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Aims: The experiment tested the effects of a web‐push survey research protocol, compared with the standard mailed paper‐and‐pencil protocol, among young adults aged 19–30 years in the 'Monitoring the Future' (MTF) longitudinal study. Design, Setting and Participants: The US‐based MTF study has measured substance use trends among young adults in panel samples followed biennially, using consistent mailed survey procedures from 1977 to 2017. In 2018, young adult participants in the MTF longitudinal component scheduled to be surveyed at ages 19–30 in 2018 (from high school senior cohorts of 2006–17, n = 14 709) were randomly assigned to receive the standard mail/paper survey procedures or new web‐push procedures. Measurements Primary outcomes were responding to the survey and prevalence estimates for past 30‐day use of alcohol, cigarettes, marijuana and illicit drugs. Findings The web‐push response rate was 39.07% [95% confidence interval (CI) = 37.889, 40.258]; this was significantly better than the standard MTF response rate of 35.12% (95% CI = 33.964, 36.285). After adjusting for covariates, the web‐push condition was associated with a 19% increase in the odds of responding compared with standard MTF (adjusted odds ratio = 1.188; 95% CI = 1.096, 1.287). Substance use prevalence estimates were very similar and differences became negligible when using attrition weights and controlling for socio‐demographic characteristics. Conclusions: The web‐push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future panel study, without substantially affecting estimates of substance use once attrition weights and socio‐demographic variables were factored in. [ABSTRACT FROM AUTHOR]

Background and Aims: Increasing numbers of school‐based drug surveys are transitioning data collection to electronic tablets from paper‐and‐pencil, which may produce a survey mode effect and consequent discontinuity in time trends for population estimates of drug prevalence. This study tested whether (a) overall, self‐reported drug use prevalence is higher on electronic tablets versus paper‐and‐pencil surveys, (b) socio‐demographics moderate survey mode effects and (c) levels of missing data are lower for electronic tablet versus paper‐and‐pencil modes. Design A randomized controlled experiment. Setting: Results are nationally representative of students in the contiguous United States. Participants: A total of 41 866 8th, 10th and 12th grade students who participated in the 2019 Monitoring the Future school‐based survey administration. Intervention and comparator: Surveys were administered to students in a randomly selected half of schools with electronic tablets (intervention) and with paper‐and‐pencil format (comparator) for the other half. Measurements Primary outcome was the total number of positive drug use responses. Secondary outcomes were the percentage of respondents completing all drug questions, percentage of drug questions unanswered and mean number of missing drug items. Findings The relative risk (RR) for total number of positive drug use responses for electronic tablets versus paper‐and‐pencil surveys were small and their 95% confidence intervals (CI) included the value of one for reporting intervals of life‐time (RR = 1.03; 95% CI, 0.93–1.14), past 12 months (RR = 1.01; 95% CI, 0.91–1.11), past 30 days (RR = 1.05; 95% CI, 0.93–1.20) and for heavy use (RR = 1.10; 95% CI, 0.93–1.29). Multiplicative interaction tests indicated no moderation of these relative risks by race (white versus non‐white), population density, census region, public/private school, year of school participation, survey version or non‐complete drug responses. Levels of missing data were significantly lower for electronic tablets versus paper‐and‐pencil surveys. Conclusions: Adolescent drug prevalence estimates in the United States differed little across electronic tablet versus paper‐and‐pencil survey modes, and showed little to no effect modification by socio‐demographics. Levels of missing data were lower for electronic tablets. [ABSTRACT FROM AUTHOR]

Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

Background Studies: Captioning and repetition are widely used multimedia instructional devices for non‐native students. Generally, studies in this area have tended to focus on second language literacy skills rather than on learning new content knowledge. Additionally, posttests were administered immediately after the treatments, while the delayed influences of captioning and repetition have never been investigated. Objectives: This paper addressed these research gaps in two separate studies. More specifically, this study attempted to examine the influences of captioning and repetition on non‐native students' immediate and relayed retention. Methods: In Study One, three captioning conditions; word‐by‐word captions, closed captions, and no‐captions; were compared to examine their efficacies in immediate and delayed content knowledge retention on 82 Chinese university students. To address the limitations in Study One as the multimedia lesson was short and played only once, Study Two incorporated captioning and two repetition types in its design. One hundred and eleven Chinese university students watch a video lesson in one of four captioning and repetition conditions. Results: The statistical analyses of Study One indicated that there were no significant differences in both immediate and delayed retention test scores across the three captioning condition. Similarly, in Study Two, there were no significant differences in retention tests scores across the four captioning and repetition conditions. Findings: Neither the availability of captions nor the repetition types had any impact on the Chinese students' immediate or delayed content knowledge retention, which lent support to existing studies. Based on the research results, the limitations and future study possibilities are discussed. Lay Description: What Is Already Known About This TopicEmpirical studies on captioning have focused on immediate learning right after the treatment, so have studies on repetition.Empirical studies on multimedia lessons for non‐native students have focused on English language learning. What This Paper AddsThree types of captioning were compared to examine their efficacies in both immediate and delayed content retention of Chinese students.Two types of repetition were compared to examine their efficacies in both immediate and delayed content retention of Chinese students. Implications for Practice and/or Policy:Neither the availability of captions nor the repetition types had any impact on the Chinese students' immediate or delayed content knowledge retention.The availability of textual keywords adjacent to their corresponding graphics might have compromised the efficacy of captioning. [ABSTRACT FROM AUTHOR]

Introduction: Media comparison studies examining the effectiveness of immersive virtual reality in education have yielded inconclusive findings, leaving the question of its impact on learning compared to conventional media unanswered. To address this issue, our study employs a novel approach that combines media comparison with an investigation on the influence of broader educational context. Methods: In the experiment, 262 students from two distinct types of lower secondary schools—comprehensive school and multi‐year gymnasium (a selective academic school)—participated. The students received a lesson on topography and contour line interpretation, using either an immersive virtual environment or a PowerPoint slideshow. A transfer test was carried out before, immediately after, and 1 month after the lesson to measure knowledge application. Results: The impact of the media (immersive virtual reality vs. PowerPoint slideshow) on learning outcomes was found to be minimal, with no clear advantage of one over the other in any experimental condition. In contrast, a significant influence on learning gains was observed due to school type. Multi‐year gymnasium students consistently outperformed comprehensive school students in the pre‐test and demonstrated greater learning gains, regardless of the learning media. Conclusion: The present study employs an innovative approach by integrating a comparative analysis of different media types with an investigation into the impact of learner characteristics. By including students from distinct types of schools, the study provides insights into the differential effects of immersive virtual reality in varied educational contexts. Lay Description: What is already known about this topic: Media comparison studies typically assess the effectiveness of immersive virtual reality as a learning medium in comparison to other instructional methods in education.The findings of these studies differ markedly.Numerous factors impact learning outcomes in an immersive virtual environment. What this paper adds: Recommendation that research in the field should explore not only if but also when and how IVR learning is effective.Evidence that learning achievements may not be affected by the medium used.Evidence that the type of school can significantly influence learning gains.Evidence that cognitive dispositions, such as spatial abilities, can be another factor that influence learning outcomes. Implications for practice: A technology‐centred approach alone does not allow for a proper evaluation of the learning gain potential of IVR, learner characteristics and broader educational context should also be taken into account.IVR as a learning medium may not be appropriate for all students and every educational setting.To ensure reliable evaluation of learning gains, it is necessary to align the content and format of the intervention in both learning mediums as closely as possible.Measuring learning gains not only immediately after the intervention but also with a significant time delay can contribute to a more comprehensive understanding. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. Method A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Results Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Conclusions Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. [ABSTRACT FROM AUTHOR]

Background: Limited research on the effectiveness of additional online and face‐to‐face practise opportunities for promoting active learning among Chinese EFL learners in higher education. Current understanding of self‐regulated and collaborative learning theories in educational contexts. Objectives: To establish the efficacy of interactive online and face‐to‐face practise opportunities for enhancing active learning among Chinese EFL learners. Methods: Employed mixed methods research to assess the impact of different types of practise opportunities on 116 EFL learners. Utilised methodological triangulation of QUAN + QUAL data and one‐way ANOVA for interpretation. Results and conclusions: The study demonstrated the effectiveness of integrating online and face‐to‐face practise opportunities to enhance active learning. Empirical evidence supports the pedagogical and theoretical benefits of these opportunities for promoting active learning among EFL learners. Lay Summary: What is currently known about this topic: Limited scholarly exploration of supplementary practise opportunities for active learning among Chinese EFL learnersExisting understanding of self‐regulated and collaborative learning theories in educational contexts What does this paper add: Establishes the effectiveness of interactive online and face‐to‐face practise opportunities for promoting active learningProvides empirical evidence supporting the integration of these opportunities to enhance active learning Implications for practise/or policy: Advocates for the combined use of online and face‐to‐face practise opportunities to enrich engagement, problem‐solving, feedback, and motivation among EFL learnersSuggests the development of instructional frameworks based on self‐regulated and collaborative learning theories for enhanced CALL courses [ABSTRACT FROM AUTHOR]

Objective: Few studies evaluated low concentrations of hydrogen peroxide protocols. The aim of this paper was evaluated two application protocols using 4% hydrogen peroxide in at‐home bleaching. Materials and Methods: Eighty‐six patients with upper canines' shade A2 or darker were randomly allocated under two experimental conditions: two daily applications of 1 h each or a 2‐h single application. Color change was evaluated using Vita Classical, Vita Bleachedguide, and digital spectrophotometer weekly and 1 month after the bleaching procedure through one‐way ANOVA. The risk and intensity of tooth sensitivity (TS) was assessed through visual and numeric rating scale and measured by Fisher's exact test, Mann–Whitney test and one‐way ANOVA respectively. Results: After 3 weeks, the mean difference for the ΔSGU Vita Classical (1.0; 95% CI −0.1 to 2.0), ΔEab (0.7; 95% CI −1.4 to 2.8), ΔE00 (0.1; 95% CI −1.4 to 1.6) and Wi (1.8; 95% CI ‐1.9 to 5.5) presented no difference (p > 0.08). The relative risk for TS was 0.91 (0.72 to 1.14) without significant difference neither in the risk (p = 0.6) nor in the TS intensity for both pain scales (p > 0.65). Conclusions: The application protocols evaluated (two daily applications of 1 h each or a 2‐h single application) for at‐home bleaching with 4% hydrogen peroxide did not showed differences in color change and tooth sensitivity. Clinical Relevance: Higher amount of active hydrogen peroxide in two daily applications for at‐home bleaching neither accelerate bleaching nor increase the risk or intensity of tooth sensibility. [ABSTRACT FROM AUTHOR]

Background: The articulatory accuracy of patients with dysarthria is one of the most affected speech dimensions with a high impact on speech intelligibility. Behavioural treatments of articulation can either involve direct or indirect approaches. The latter have been thoroughly investigated and are generally appreciated for their almost immediate effects on articulation and intelligibility. The number of studies on (short‐term) direct articulation therapy is limited. Aims: To investigate the effects of short‐term, boost articulation therapy (BArT) on speech intelligibility in patients with chronic or progressive dysarthria and the effect of severity of dysarthria on the outcome. Methods & Procedures: The study consists of a two‐group pre‐/post‐test design to assess speech intelligibility at phoneme and sentence level and during spontaneous speech, automatic speech and reading a phonetically balanced text. A total of 17 subjects with mild to severe dysarthria participated in the study and were randomly assigned to either a patient‐tailored, intensive articulatory drill programme or an intensive minimal pair training. Both training programmes were based on the principles of motor learning. Each training programme consisted of five sessions of 45 min completed within one week. Outcomes & Results: Following treatment, a statistically significant increase of mean group intelligibility was shown at phoneme and sentence level, and in automatic sequences. This was supported by an acoustic analysis that revealed a reduction in formant centralization ratio. Within specific groups of severity, large and moderate positive effect sizes with Cohen's d were demonstrated. Conclusions & Implications: BArT successfully improves speech intelligibility in patients with chronic or progressive dysarthria at different levels of the impairment. What this paper addsWhat is already known on the subjectBehavioural treatment of articulation in patients with dysarthria mainly involves indirect strategies, which have shown positive effects on speech intelligibility. However, there is limited evidence on the short‐term effects of direct articulation therapy at the segmental level of speech. This study investigates the effectiveness of BArT on speech intelligibility in patients with chronic or progressive dysarthria at all severity levels.What this paper adds to existing knowledgeThe intensive and direct articulatory therapy programmes developed and applied in this study intend to reduce the impairment instead of compensating it. This approach results in a significant improvement of speech intelligibility at different dysarthria severity levels in a short period of time while contributing to exploit and develop all available residual motor skills in persons with dysarthria.What are the potential or actual clinical implications of this work?The improvements in intelligibility demonstrate the effectiveness of a BArT at the segmental level of speech. This makes it to be considered a suitable approach in the treatment of patients with chronic or progressive dysarthria. [ABSTRACT FROM AUTHOR]

Given the widespread use of touch screen devices, the effect of the users' fingers on information processing and learning is of growing interest. The present study drew on cognitive load theory and embodied cognition perspectives to investigate the effects of pointing and tracing gestures on the surface of a multimedia learning instruction. Learning performance, cognitive load and visual attention were examined in a one‐factorial experimental design with the between‐subject factor pointing and tracing gestures. The pointing and tracing group were instructed to use their fingers during the learning phase to make connections between corresponding text and picture information, whereas the control group was instructed not to use their hands for learning. The results showed a beneficial effect of pointing and tracing gestures on learning performance, a significant shift in visual attention and deeper processing of information by the pointing and tracing group, but no effect on subjective ratings of cognitive load. Implications for future research and practice are discussed. Lay Description: What is currently known about the subject matter? Pointing and tracing gestures enhance learning with multimediaThe effect is true for paper based and digital learning instructionsLess is known about the cause of this effect with regard to complex learningDifferent theoretical explanations are currently discussed What our paper adds to this A detailed analysis of the effect using eye‐tracking and touch screen dataEvidence that the effect of pointing and tracing is mediated by eye‐movementsRelevant information concerning the discussion about theoretical explanations The implications of study findings for practitioners Pointing and tracing gestures can guide the learners' visual focus of attentionPointing and tracing gestures can increase the learners' visual attentionPointing and tracing gestures foster information processing when learning with multimediaLearners can or even should use pointing and tracing gestures to support learning [ABSTRACT FROM AUTHOR]

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Supportive counseling and facilitated referrals to support organizations have shown positive effects on mental health and coping with domestic and family violence. However, the reasons why and how such effects are significant remain unknown. The current paper used data from a randomized controlled trial of a psychosocial intervention implemented in Nepal among 140 abused pregnant women. The hypothesized mediating effects of self‐efficacy and social support on mental health and quality of life of abused pregnant women were tested using serial mediation analyses. Significance of parameter estimates and bias‐corrected 95% confidence intervals (CIs) for the indirect effects were generated using bootstrapping. The postintervention changes in self‐efficacy and social support were found to have significant mediating effects on the relationship between the intervention and changes in both mental health and quality of life of participants post intervention. The positive effects on outcomes were seen at follow‐up as well, though to a lesser extent. Further interventions should focus on enhancing abused women's self‐efficacy and social support to ensure their positive mental health and better lives. [ABSTRACT FROM AUTHOR]

Background: Though pedagogical artificial agents are expected to play a crucial role in the years to come, earlier studies provide inconsistent results regarding their effect on learning. This might be because their potential for exhibiting subtle nonverbal behaviours we know from human teachers has been untapped. What is more, there is little evidence of the processes underlying the effect of nonverbal behaviours of teachers (either human or artificial) on learning, so as to better guide their practical application. Objectives: The aims of the current research were threefold: firstly, to examine the effect of an artificial agent's vocal expressiveness on non‐verbal immediacy (teachers' ability to increase psychological closeness through nonverbal communication). Secondly, to test whether an artificial agent showing strong vocal expressiveness will enhance affective and cognitive learning (perceived and actual), as compared to an artificial agent that shows weak vocal expressiveness. Thirdly, to examine whether the underlying mechanisms of motivation and attention explain the effect of immediacy (and thereby also of vocal expressiveness) on the two learning outcomes. Methods: The study used a between‐participants design, with the participants being randomly assigned to one of the two experimental conditions: artificial modelling with strong expressiveness and artificial modelling with weak vocal expressiveness. Results and conclusions: Results showed that an artificial agent with strong vocal expressiveness increased affective and perceived cognitive learning. Partial support was found for actual cognitive learning. What is more, our findings revealed that vocal expressiveness is related to affective and perceived cognitive learning because it promotes nonverbal immediacy. Finally, results provided evidence of motivation as a mediator of the path from immediacy to affective learning. Major takeaways: The current findings verify the important role of nonverbal immediacy found in traditional educational settings. However, showing that these results also apply to artificial teachers is essential, given that the educational landscape is changing and reshaping by artificial intelligence. Thus, taking into consideration the role of vocal expressiveness in the development of artificial teachers or voice assistants like Alexa, Siri, and Google assistant, as a way to enhance immediacy and affective experience of learners is of imperative value, since they will be found more and more in our societies. Lay Description: What is currently known about the subject matter: There is a positive effect of nonverbal cues of human teachers on students' learningThe artificial agent's voice is important for learning. What their paper adds to this: Provides strong evidence of the positive effect of vocal expressiveness of artificial agents on learning outcomes.Reveals that vocal expressiveness is related to learning outcomes because it enhances immediacy.Examines the proposed mechanisms of motivation and attention as mediators of the path from immediacy to affective and cognitive learning. Implications of study findings for practitioners: Taking into consideration vocal expressiveness of artificial agents during the design process is essential for increased learning.The combination of the vocal parameters of pitch and speech rate is effective for constructing vocal expressiveness.By showing the underlying mechanisms of artificial agents' nonverbal cues (i.e., vocal cues) on learning, it helps designers to make a better decisions during construction.The study's findings are also pertinent for human teachers in improving students' learning in traditional educational settings. [ABSTRACT FROM AUTHOR]

Learning and teaching algebra concepts are frequent problems for both students and teachers alike. Students struggle to learn algebra, and teachers struggle to identify the best way to teach algebra. It is recurrent that teachers use instructional methods that promote memorization, and, consequently, the learning process may prove unsatisfactory. This paper introduces Virtual Algebra Tiles, an open educational resource whose purpose is to enable students to use algebra tiles from a computer to enhance their knowledge of algebra concepts. To evaluate the effectiveness of the system, we designed a case study. The participants were 40 students of engineering degrees who were randomly assigned to experimental or control groups. Results indicate that the system has a large effect size (ES = 0.83, p < 0.001) on learning effectiveness and a promising long‐term knowledge retention (ES = 0.79, p < 0.001). Students concluded that this version of algebra tiles is more motivating than other versions, because it is presented in a format that stands natural to them. Students feel more comfortable in virtual environments, and therefore, the learning process becomes a more pleasant task. Lay Description: What is already known about this topic: Inadequate teaching methodologies can lead to student failure.It is necessary to decrease the emphasis on memorization and to favour active learning techniques.The use of mathematical manipulatives increases students' learning gains.Algebra tiles are an educational resource that helps students understand algebra concepts by using geometric figures. What this paper adds: Virtual Algebra Tiles is a multimedia version of the educational resource algebra tiles.Virtual Algebra Tiles has a large effect size on students' learning achievements.Virtual Algebra Tiles improves students' long‐term knowledge retention. Implications for practices and/or policy: Teachers should participate in the development of digital pedagogical material to enrich their lectures.It is necessary to develop more open educational resources, which can be accessed by students and teachers.Digital educational resources must take into account the special needs of particular users. [ABSTRACT FROM AUTHOR]

Developing oral presentation skills is an essential objective of higher education. While previous research emphasized the importance of practice for developing oral presentation skills (OPS), it remains unclear what the optimal amount of practice is. This experimental field study examined the added benefit of an extra practice session in virtual reality (VR) on the progression of 35 graduate students in OPS, using a pre‐test post‐test design. In addition, the mediating effect of public speaking anxiety (PSA) was examined and the relation between PSA, preparation practices, perceived utility of VR and OPS was explored. Questionnaires and performance assessments were used in data collection. Results showed that participants gained benefits from practicing a third time before a virtual audience. Both anxious and non‐anxious participants progressed similarly on presentation skills and experienced the VR intervention comparably. However, the optimal number of practice presentations remains unclear and should be further investigated. Lay Description: What is currently known about the subject matter: Presenting is recognized as a core competence for higher educated professionals in various domains.The opportunity to practice oral presentations is considered a crucial learning environment characteristic.Modern technological solutions can offer time‐ and place‐independent practice opportunities.It remains unclear what the optimal amount of practice is for developing oral presentation skills. What this paper adds to this: This study aims to provide empirical evidence for the optimal number of practice sessions on oral presentation performance.Results showed that participants gained benefits from practicing a third time before a virtual audience.Both anxious and non‐anxious participants progressed similarly on presentation skills and experienced the VR intervention comparably.The optimal number of practice presentations remains unclear and should be further investigated. The implications of study findings for practitioners: Practicing several times in front of a (virtual) audience should be facilitated by educational institutions.VR can be a useful tool to facilitate repeated practice sessions, by saving both in‐class time and offering the opportunity to practice independently.VR can be used in presentation trainings for several target groups, including those with high communication‐related anxieties. [ABSTRACT FROM AUTHOR]

As immersive virtual reality (IVR) systems proliferate in classrooms, it is important to understand how they affect learning outcomes and the underlying affective and cognitive processes that may cause these outcomes. Proponents argue that IVR could improve learning by increasing positive affective and cognitive processing, thereby supporting improved performance on tests of learning outcome, whereas opponents of IVR contend that it could hurt learning by increasing distraction, thereby disrupting cognitive learning processes and leading to poorer learning outcomes. In a media comparison study, students viewed a biology lesson either as an interactive animated journey in IVR or as a slideshow on a desktop monitor. Those who viewed the IVR lesson performed significantly worse on transfer tests, reported higher emotional arousal, reported more extraneous cognitive load and showed less engagement based on EEG measures than those who viewed the slideshow lesson, with or without practice questions added to the lessons. Mediational analyses showed that the lower retention scores for the IVR lesson were related to an increase in self‐reported extraneous cognitive load and emotional arousal. These results support the notion that immersive environments create high affective and cognitive distraction, which leads to poorer learning outcomes than desktop environments. Lay Description: What is already known about the topic: IVR is gaining popularity in classrooms, and it is important to understand its effects on learning.Some theories suggest IVR could help learning because it may increase motivation.Other theories suggest IVR could hurt learning because it causes distraction. What this paper adds: The biology lesson displayed in IVR led to less learning than a PowerPoint lesson.Viewing the IVR lesson caused higher emotional arousal than viewing the PowerPoint lesson.The IVR lesson led to more distraction based on self‐report and EEG measures than the PowerPoint lesson.These results suggest that IVR creates high emotional and cognitive distraction, which leads to less learning. Implications for practice: Using IVR to replace traditional classroom lessons may not yet be useful.However, because students report enjoying IVR, it may be useful to use in addition to conventional lessons.Future research should determine how specific factors of the technology and the learners affect learning outcomes. [ABSTRACT FROM AUTHOR]

Intravaginal rings (IVRs) are an established option for continuous administration of drugs in women. The combination of anastrozole (ATZ) and levonorgestrel (LNG) in an IVR with an intended 4‐week wearing period has been considered for long‐term treatment of endometriosis‐associated pelvic pain. A randomized, parallel‐group, multicenter phase 2b study to assess the efficacy and safety of different dose combinations in women with symptomatic endometriosis has recently been performed. This paper will focus on the investigation of pharmacokinetic (PK) effects of ATZ on LNG using data collected from this study. Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 μg/day alone or in combination with ATZ 300 μg/day, 600 μg/day, or 1050 μg/day for 12 weeks. PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84). The primary PK parameter was the plasma concentration in apparent steady state of ATZ and LNG at the end of each IVR wearing period. Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, respectively). All point estimates for LNG concentration in apparent steady state ratios between the mono and combination IVR groups were close to 1, and the 90% confidence interval limits were in the 0.80 to 1.25 range (1.01 [0.85‐1.19], 1.03 [0.88‐1.20], 0.94 [0.80‐1.10]). In conclusion, our data indicate there is no evidence of drug‐drug interaction of ATZ on LNG. [ABSTRACT FROM AUTHOR]

Behaviour change communication (BCC) can improve infant and young child nutrition (IYCN) knowledge, practices, and health outcomes. However, few studies have examined whether the improved knowledge persists after BCC activities end. This paper assesses the effect of nutrition sensitive social protection interventions on IYCN knowledge in rural Bangladesh, both during and after intervention activities. We use data from two, 2-year, cluster randomised control trials that included nutrition BCC in some treatment arms. These data were collected at intervention baseline, midline, and endline, and 6-10 months after the intervention ended. We analyse data on IYCN knowledge from the same 2,341 women over these 4 survey rounds. We construct a number correct score on 18 IYCN knowledge questions and assess whether the impact of the BCC changes over time for the different treatment groups. Effects are estimated using ordinary least squares accounting for the clustered design of the study. There are 3 main findings: First, the BCC improves IYCN knowledge substantially in the 1st year of the intervention; participants correctly answer 3.0-3.2 more questions (36% more) compared to the non-BCC groups. Second, the increase in knowledge between the 1st and 2nd year was smaller, an additional 0.7-0.9 correct answers. Third, knowledge persists; there are no significant decreases in IYCN knowledge 6-10 months after nutrition BCC activities ended. [ABSTRACT FROM AUTHOR]

Responsive feeding serves as an important protective factor for infant growth and overall health development. This study based on self‐determination theory (SDT) aimed to assess the effects of a responsive breastfeeding (RBF) intervention programme on maternal breastfeeding and infant growth and development. A total of 110 mother–infant pairs were recruited and randomly divided into an intervention group (n = 55) and a control group (n = 55). The primary outcomes were breastfeeding motivation score, breastfeeding self‐efficacy (BSE) and exclusive breastfeeding rate; the secondary outcomes were infant physical development at 6 weeks and 3 months. A repeated measures ANOVA indicated that the intervention group had significantly higher Enjoyment scores compared to the control group at three time points: at discharge (MD: 5.28; 95% CI: 3.68 to 6.89; p < 0.001), 6 weeks post‐partum (MD: 5.06; 95% CI: 3.80 to 6.31; p < 0.001) and 3 months post‐partum (MD: 5.24; 95% CI: 4.12 to 6.35; p < 0.001). Similarly, the intervention group reported significantly higher connection and mother's self‐perception scores at discharge (MD: 4.31; 95% CI: 3.07 to 5.56; p < 0.001), 6 weeks post‐partum (MD: 4.69; 95% CI: 3.71 to 5.68; p < 0.001) and 3 months post‐partum (MD: 4.93; 95% CI: 4.14 to 5.72; p < 0.001), compared to the control group. In contrast, the pressure from significant others scores were higher in the control group relative to the intervention group at discharge (MD: −2.09; 95% CI: −2.88 to −1.31; p < 0.001), 6 weeks post‐partum (MD: −4.35; 95% CI: −5.20 to −3.49; p < 0.001) and 3 months (MD: −4.89; 95% CI: −5.70 to −4.08; p < 0.001). Finally, the intervention group also reported higher Instrumental Needs scores at all three time points: at discharge (MD: 1.96; 95% CI: 1.35 to 2.58; p < 0.001), 6 weeks post‐partum (MD: 3.58; 95% CI: 3.05 to 4.11; p < 0.001) and 3 months post‐partum (MD: 1.18; 95% CI: 0.68 to 1.69; p < 0.001). BSE scores were significantly higher in the intervention group compared to the control group at discharge (MD: 14.29; 95% CI: 10.38 to 18.21; p < 0.001), 6 weeks post‐partum (MD: 14.04; 95% CI: 11.05 to 17.02; p < 0.001) and 3 months post‐partum (MD: 6.80; 95% CI: 4.66 to 8.94; p < 0.001). The rates of exclusive breastfeeding were higher in the intervention group than in the control group at each stage of the intervention (p < 0.01). At 6 weeks post‐partum, the intervention group's infants showed slower weight (t = −0.90, p = 0.371) and length (t = −0.69, p = 0.495) growth compared to the control group, though not significantly. By 3 months post‐partum, there was a significant difference in both weight (t = −3.46, p = 0.001) and length (t = −2.95, p = 0.004) between the groups. The findings in this study suggest that the RBF intervention programme based on SDT may be effective in improving mothers' motivation to breastfeed, building breastfeeding self‐confidence and increasing the rate of exclusive breastfeeding. The effects of the intervention on infant physical development will need to be verified with longer follow‐up in future research. Key messages: This study validated the application of responsive breastfeeding (RBF) intervention during the exclusive breastfeeding phase of Chinese infants.The RBF intervention may help to increase mothers' level of autonomous motivation for breastfeeding, enhance breastfeeding self‐efficacy and increase exclusive breastfeedingrates. The intervention had no significant effect on the weight and length of 6 week old infants but significantly impacted 3monthold infants, with slower growth observed in the intervention group compared to the control group.Future intervention programmes shouldinclude extended follow‐up periods to investigate the long‐term effects of RBF on infant growth and development. [ABSTRACT FROM AUTHOR]

Millions of children in low-income and middle-income countries falter in linear growth and neurobehavioral development early in life. This faltering may be caused by risk factors that are associated with both growth and development, such as insufficient dietary intake and infection in infancy. Alternatively, these risk factors may be indicative of an environment that constrains both linear growth and development through different mechanisms. In a cluster-randomized trial in Burkina Faso, we previously found that provision of lipid-based nutrient supplements plus malaria and diarrhoea treatment from age 9 to 18 months resulted in positive effects of ~0.3 standard deviation on length-for-age z-score (LAZ) and of ~0.3 standard deviation on motor, language and personal-social development scores at age 18 months. In this paper, we examined whether the effect of the intervention on developmental scores was mediated by the effect on LAZ, or, alternatively, whether the intervention had independent effects on growth and development. For motor, language, and personal-social z-scores, the effect of the intervention decreased from 0.32 to 0.21, from 0.33 to 0.27 and from 0.35 to 0.29, respectively, when controlling for change in LAZ from 9 to 18 months. All effects remained significant. These results indicate that the intervention had independent positive effects on linear growth and development, suggesting that these effects occurred through different mechanisms. © 2016 John Wiley & Sons Ltd [ABSTRACT FROM AUTHOR]

Objective Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs). Methods We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT. Results Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT ( P = 0.02). Conclusion We have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc. [ABSTRACT FROM AUTHOR]

Background/aim Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness. Methods Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults. Results Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation ( ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores. Conclusions ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time. [ABSTRACT FROM AUTHOR]

Prenatal iron supplementation improves children's health and cognitive performance, but few studies explore behavioural development. This study assessed the effects of adjusting prenatal iron supplementation to maternal iron stores during early pregnancy on children's behavioural problems. Randomized controlled trial conducted in Tarragona (Spain) involving 230 nonanaemic pregnant women and their children after a 4‐year follow‐up. Based on haemoglobin (Hb) levels before gestational week (GW) 12, women receive different iron doses: those with Hb = 110–130 g/L were randomized to receive 80 or 40 mg/day and those with Hb > 130 g/L were randomized to receive 20 or 40 mg/day. Maternal iron stores at GW12 were classified using serum ferritin (SF) as low (SF < 15 µg/L), normal (SF = 15–65 µg/L), and normal‐high (SF > 65 µg/L). Children's behaviour was assessed by parents using the Child Behaviour Checklist for ages 1.5–5 years and the Behaviour Rating Inventory of Executive Function‐Preschool Version, and by teachers using the Teacher's Report Form for ages 1.5–5 years. Multivariable regression models were performed. Taking 80 mg/day of iron improved child behaviour when women had low iron stores but worsened it when mothers had normal–high iron stores, except for depressive and attention/hyperactivity problems. Taking 20 mg/day of iron improved behaviour only in those children whose mothers had SF > 65 µg/L in early pregnancy. Additionally, executive functioning improved at high doses of prenatal iron when maternal baseline SF < 15 µg/L. Adjusting prenatal iron supplementation to both maternal baseline Hb levels and iron stores reduces behavioural problems in 4‐year‐old children. Key messages: Prenatal iron supplementation succeeds in improving maternal haematological outcomes and cognitive performance of children, but few studies have focused on behavioural development.Prenatal iron supplementation adjusted to maternal iron stores reduces behavioural problems in 4‐year‐old children.Maternal iron stores early in pregnancy should be measured in addition to haemoglobin concentration.These findings contribute greatly to the advancement of public health by giving physicians the tools to prescribe the most appropriate dose of iron supplementation to contribute to better child development. [ABSTRACT FROM AUTHOR]

To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P =.0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P =.0391,.0391, and.0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P =.03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P =.0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites. [ABSTRACT FROM AUTHOR]

Background: No previous studies have reported predictors and moderators of outcome of psychological therapies for depression experienced by adults with intellectual disabilities (IDs). We investigated baseline variables as outcome predictors and moderators based on a randomised controlled trial where behavioural activation was compared with guided self‐help. Methods: This study was an exploratory secondary data analysis of data collected during a randomised clinical trial. Participants (n = 161) were randomised to behavioural activation or guided self‐help and followed up for 12 months. Pre‐treatment variables were included if they have previously been shown to be associated with an increased risk of having depression in adults with IDs or have been reported as a potential predictor or moderator of outcome of treatment for depression with psychological therapies. The primary outcome measure, the Glasgow Depression Scale for Adults with Learning Disabilities (GDS‐LD), was used as the dependant variable in mixed effects regression analyses testing for predictors and moderators of outcome, with baseline GDS‐LD, treatment group, study centre and antidepressant use as fixed effects, and therapist as a random effect. Results: Higher baseline anxiety (mean difference in outcome associated with a 1 point increase in anxiety 0.164, 95% confidence interval [CI] 0.031, 0.297; P = 0.016), lower performance intelligence quotient (IQ) (mean difference in outcome associated with a 1 point increase in IQ 0.145, 95% CI 0.009, 0.280; P = 0.037) and hearing impairment (mean difference 3.449, 95% CI 0.466, 6.432; P = 0.024) were predictors of poorer outcomes, whilst greater severity of depressive symptoms at baseline (mean difference in outcome associated with 1 point increase in depression −0.160, 95% CI −0.806, −0.414; P < 0.001), higher expectation of change (mean difference in outcome associated with a 1 point increase in expectation of change −1.013, 95% CI −1.711, −0.314; p 0.005) and greater percentage of therapy sessions attended (mean difference in outcome with 1 point increase in percentage of sessions attended −0.058, 95% CI −0.099, −0.016; P = 0.007) were predictors of more positive outcomes for treatment after adjusting for randomised group allocation. The final model included severity of depressive and anxiety symptoms, lower WASI performance IQ subscale, hearing impairment, higher expectation of change and percentage of therapy sessions attended and explained 35.3% of the variance in the total GDS‐LD score at 12 months (R2 = 0.353, F4, 128 = 17.24, P < 0.001). There is no evidence that baseline variables had a moderating effect on outcome for treatment with behavioural activation or guided self‐help. Conclusions: Our results suggest that baseline variables may be useful predictors of outcomes of psychological therapies for adults with IDs. Further research is required to examine the value of these potential predictors. However, our findings suggest that therapists consider how baseline variables may enable them to tailor their therapeutic approach when using psychological therapies to treat depression experienced by adults with IDs. [ABSTRACT FROM AUTHOR]

Nutrition‐sensitive agriculture programmes have the potential to improve child nutrition outcomes, but livestock intensification may pose risks related to water, sanitation and hygiene (WASH) conditions. We assessed the impact of SELEVER, a nutrition‐ and gender‐sensitive poultry intervention, with and without added WASH focus, on hygiene practices, morbidity and anthropometric indices of nutrition in children aged 2−4 years in Burkina Faso. A 3‐year cluster randomised controlled trial was implemented in 120 villages in 60 communes (districts) supported by the SELEVER project. Communes were randomly assigned using restricted randomisation to one of three groups: (1) SELEVER intervention (n = 446 households); (2) SELEVER plus WASH intervention (n = 432 households); and (3) control without intervention (n = 899 households). The study population included women aged 15−49 years with an index child aged 2−4 years. We assessed the effects 1.5‐years (WASH substudy) and 3‐years (endline) post‐intervention on child morbidity and child anthropometry secondary trial outcomes using mixed effects regression models. Participation in intervention activities was low in the SELEVER groups, ranging from 25% at 1.5 years and 10% at endline. At endline, households in the SELEVER groups had higher caregiver knowledge of WASH‐livestock risks (∆ = 0.10, 95% confidence interval [CI] [0.04−0.16]) and were more likely to keep children separated from poultry (∆ = 0.09, 95% CI [0.03−0.15]) than in the control group. No differences were found for other hygiene practices, child morbidity symptoms or anthropometry indicators. Integrating livestock WASH interventions alongside poultry and nutrition interventions can increase knowledge of livestock‐related risks and improve livestock‐hygiene‐related practices, yet may not be sufficient to improve the morbidity and nutritional status of young children. Key messages: Few experimental studies have examined the potential nutritional benefits and health risks of livestock‐related interventions in low‐and middle‐income settings.We conducted a 3‐year cluster randomised trial of nutrition‐ and gender‐sensitive poultry intervention in Burkina Faso.Despite low participation in the intervention activities, caregiver's knowledge of water, sanitation and hygiene‐livestock risks was higher in the intervention groups than in the control group.No effects were found on hygiene and hygiene‐livestock‐related practices (except for practices involving separation between livestock and children) nor on child morbidity symptoms and anthropometry indicators. [ABSTRACT FROM AUTHOR]

Background: Primary care settings like federally qualified health centers (FQHC) are optimal locations to identify individuals with substance use disorders (SUD) and link them to SUD treatment, yet successful linkage has proven difficult. Recovery management checkups for primary care (RMC‐PC) is a promising method for increasing linkage to care, engagement in treatment, and reducing substance use. Methods: Participants (n = 266) who received screening, brief intervention, and referral to treatment (SBIRT) at four FQHC sites and needed SUD treatment were randomized to receive SBIRT only or SBIRT+RMC‐PC. All participants received SBIRT prior to randomization as part of usual care while those in the experimental group also received quarterly checkups. All participants completed research interviews at enrollment and 3, 6, 9, and 12 months post‐enrollment. The primary outcome was whether participants received any days of SUD treatment. Key secondary outcomes were days of SUD treatment (total and by SUD level of care), days of alcohol or drug abstinence, and a reduction in days of specific substance use, all based on self‐report. Results: Relative to participants receiving SBIRT only, participants assigned to SBIRT+RMC‐PC were significantly more likely to have received any SUD treatment over 12 months (adjusted odds ratio [AOR] = 3.85) and more days of SUD treatment over 12 months (Cohen's effect size d = +0.41). The SBIRT+RMC‐PC group also reported significantly more days of abstinence over 12 months (d = +0.30), fewer days of alcohol use (d = −0.20) and cannabis use (d = −0.20), and lower combined substance use frequency (d = −0.25). Days of treatment were found to positively mediate the direct effect of SBIRT+RMC‐PC on days of abstinence. Conclusion: This study provides further evidence of the effectiveness of the "referral to treatment" component of SBIRT when combined with RMC for patients in primary care settings, including those with drug use problems. Moreover, results demonstrate the value of repeated checkups on longer‐term treatment and substance use outcomes. [ABSTRACT FROM AUTHOR]

Background: Disc displacement with reduction (DDwR) therapy should be performed only when pain or discomfort is presented. Data on treatment options for painful DDwR are very limited. Objective: The aim was to investigate whether isometric training of the lateral pterygoid muscle (LPM) is equivalent to stabilisation appliance therapy with regard to the treatment of painful DDwR. The training program is based on the science of Janda. Methods: This was a prospective, randomised study with a comparative treatment group. Sixty patients (≥18 years) with DDwR and pain were randomly assigned to two groups: (1) muscle training and (2) stabilisation appliance. The following variables were recorded at baseline examination and after 2, 4 and 6 months: changes in orofacial pain, clicking sounds of the temporomandibular joint (TMJ), force degrees for the lateral movement of the mandible and interincisal opening distance. p values of <.05 were considered statistically significant but 95% confidence intervals were also presented. Results: A decrease in orofacial pain intensity was seen in both groups (p <.0001). Registered TMJ clicking disappeared after 6 months of treatment in 37% (n = 11) of the patients in the training group and in 27% (n = 8) of the appliance group (p =.0009 and p =.0047). Muscle training showed 27 improvements in Janda force degrees at the end of the study (p <.0001). Conclusion: Muscle training and appliance therapy improved mouth opening and reduced pain intensity in both patient groups. Muscle training might be a promising option in the treatment of patients suffering from painful DDwR. [ABSTRACT FROM AUTHOR]

Background: Rates of depression are increasing among adolescents. A novel way to reduce depression is by improving sleep. We evaluated whether an app‐based intervention for insomnia improved sleep and depression, and whether changes in insomnia mediated changes in depression. Methods: We conducted a 2‐arm single‐blind randomised controlled trial at the Black Dog Institute in Australia. Adolescents 12–16 years experiencing insomnia symptoms were randomly allocated to receive Sleep Ninja, an app‐delivered cognitive behavioural therapy program for insomnia, or to an active control group involving weekly text message sleep tips. Assessments took place at baseline, 6 weeks (post‐intervention) and 14 weeks (post‐baseline). Co‐primary outcomes were symptoms of insomnia and depression at post‐intervention (primary endpoint). Intent‐to‐treat analyses were conducted. The trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12619001462178. Results: Between October 25, 2019, and September 6, 2020, 264 participants were randomised to receive Sleep Ninja (n = 131) or to the control group (n = 133). Relative to the control group, those allocated to the intervention reported a greater reduction in insomnia symptoms at 6 weeks (95% CI: −2.96 to −0.41, d =.41) and 14 weeks (95% CI: −3.34 to −0.19, d =.39), and a greater reduction in depression symptoms at 6 weeks (95% CI: −3.46 to −0.56, d =.28) but not 14 weeks (p < 1). Change in insomnia mediated change in depression. No adverse events were reported. Conclusions: An app‐delivered program for insomnia could be a practical, non‐stigmatising and scalable way to reduce symptoms of insomnia and depression among adolescents experiencing difficulties getting enough good quality sleep. [ABSTRACT FROM AUTHOR]

Background: Sensitive responsiveness is an important aspect in affect‐regulation of people with severe to profound intellectual disabilities. Aim: This randomized controlled trial evaluated the Attune & Stimulate‐checklist, a tool for detecting subtle and idiosyncratic communicative behaviours and responding adequately. Methods: Effects on the sensitive responsiveness of professional caregivers and the arousal and valence of adults with severe to profound intellectual disabilities were investigated. Video recordings of 102 interactions were analysed with several observation instruments. Results: Although no significant effect was found on the checklist‐suggestions of responsive behaviours (d = 0.33, p =.052), the intervention increased caregivers' sensitive responsive and affective behaviour (d = 0.94 – 1.10, p <.001) and clients' optimal arousal (d = 0.48, p =.019) and interactive engagement (d = 0.40 – 0.48, p =.018 ‐.050). Conclusion: This low‐intensity intervention had a medium to large immediate effect on the interaction. Future research should investigate medium‐ and long‐term effects. [ABSTRACT FROM AUTHOR]

Prolonged wound discharge is a common postoperative complication of orthopaedic procedures and a risk factor for implant‐related infection. Occlusive wound closure methods have previously been suggested to reduce or even prevent this complication. We performed a randomised controlled trial on 70 patients who underwent surgical treatment for metastatic bone disease involving the proximal femur at our centre between January 2017 and August 2018. At conclusion of the tumour resection and endoprosthetic reconstruction procedure, patients were randomised to either occlusive wound closure (n = 35), using the Dermabond Prineo‐22 skin closure system, or routine wound closure with conventional skin staples (n = 35). Skin closure with occlusive wound closure resulted in a lesser degree (P <.0001) and shorter duration of postoperative wound discharge (HR 2.89 [95% CI 1.6–5.05], P <.0018). Compared with staples, surgical wounds were already dry after a mean of 3.5 days [95% CI 3.2–3.9] versus 6.1 days [95% CI 4.8–7.3] (P <.0001). Prolonged wound discharge for 7 days or more was observed in 23% of patients (n = 8) in the Staples‐group but was entirely absent in the occlusive wound closure group (P <.003). This study provides strong evidence that occlusive wound closure reduces frequency, degree, and duration of wound discharge in a patient population at particularly high risk for this complication. [ABSTRACT FROM AUTHOR]

Objectives: The primary aim was to investigate the effect of prefabricated foot orthoses on pain and function in people with chronic nonspecific low back pain (LBP). Secondary aims were to report on the recruitment rate, adherence to and safety of these interventions, and the relationship between physical activity and pain and function. Design: A two‐arm parallel group (intervention vs. control) randomised (1:1) controlled trial. Subjects: Forty‐one participants with chronic nonspecific LBP. Intervention: Twenty participants were randomised to the intervention group (prefabricated foot orthotic and The Back Book) and 21 to the control group (The Back Book). The primary outcomes for this study were change in pain and function from baseline to 12 weeks. Results: No statistically significant difference in pain was found between the intervention and control group (adjusted mean difference −0.84, 95% CI: −2.09 to 0.41, p = 0.18) at the 12‐week follow‐up. No statistically significant difference in function was found between the intervention and control group (adjusted mean difference −1.47, 95% CI: −5.51 to 2.57, p = 0.47) at the 12‐week follow‐up. Conclusion: This study found no evidence of a significant beneficial effect of prefabricated foot orthoses for chronic nonspecific LBP. This study demonstrated that the rate of recruitment, intervention adherence and safety, and participant retention is acceptable and supportive of conducting a larger randomised controlled trial. Australian and New Zealand Clinical Trials Registry (ACTRN12618001298202). [ABSTRACT FROM AUTHOR]

Background: Exercise for people with whiplash associated disorder (WAD) induces hypoalgesic effects in some, but hyperalgesic effects in others. We investigated the exercise‐induced neurobiological effects of aerobic and strengthening exercise in individuals with chronic WAD. Methods: Sixteen participants (8 WAD, 8 pain‐free [CON]) were randomised to either aerobic or strengthening exercise. MRI for brain morphometry, functional MRI for brain connectivity, and magnetic resonance spectroscopy for brain biochemistry, were used at baseline and after the 8‐week intervention. Results: There were no differences in brain changes between exercise groups in either the WAD or CON group, therefore aerobic and strengthening data were combined to optimise sample size. After the exercise intervention, the CON group demonstrated increased cortical thickness (left parahippocampus: mean difference = 0.04, 95% CI = 0.07–0.00, p = 0.032; and left lateral orbital frontal cortex: mean difference = 0.03, 95% CI = 0.00–0.06, p = 0.048). The WAD group demonstrated an increase in prefrontal cortex (right medial orbital frontal) volume (mean difference = 95.57, 95% CI = 2.30–192.84, p = 0.046). Functional changes from baseline to follow‐up between the default mode network and the insula, cingulate cortex, temporal lobe, and somatosensory and motor cortices, were found in the CON group, but not in the WAD group. There were no changes post‐exercise in brain biochemistry. Conclusion: Aerobic and strengthening exercises did not exert differential effects on brain characteristics, however differences in structural and functional changes were found between WAD and CON groups. This suggests that an altered central pain modulatory response may be responsible for differential effects of exercise in individuals with chronic WAD. [ABSTRACT FROM AUTHOR]

Background: We assessed the change in obstetric management after implementation of a quality improvement intervention, the Nepal Perinatal Quality Improvement Package (NePeriQIP). Methods: The Nepal Perinatal Quality Improvement Package was a stepped‐wedge cluster‐randomized controlled trial conducted in 12 public hospitals in Nepal between April 2017 and October 2018. In this study, three hospitals allocated at different time points to the intervention were selected for a nested before–after analysis. We used bivariate and multivariate analyses to compare obstetric management in the control vs intervention group. Results: There were 25 977 deliveries in the three hospitals during the study period: 10 207 (39%) in the control and 15 770 (61%) in the intervention group. After adjusting for maternal age, ethnicity, education, gestational age, stage of labor at admission, complications during labor, and birthweight, the intervention group had a higher proportion of fetal heart rate monitoring performed as per protocol (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12–1.27), shorter time intervals between each fetal heart rate monitoring (aOR 2.09, 95% CI 1.96–2.23), a higher likelihood of abnormal fetal heart rate being detected (aOR 1.53, 95% CI 1.25–1.68), progress of labor more often being recorded immediately after per vaginal examination (aOR 2.73, 95% CI 2.55–2.93), and partograph filled as per standards (aOR 3.18, 95% CI 2.98–3.50). The cesarean birth rate was 2.5% in the control group and 8.2% in the intervention group (aOR 3.12, 95% CI 2.64–3.68). Conclusions: The NePeriQIP intervention has potential to improve obstetric care, especially intrapartum fetal surveillance, in similar low‐resource settings. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or first‐degree perineal tears after birth. Methods: We conducted a preliminary efficacy, open‐label, randomized, controlled, and prospective trial. This study implemented Simon's 2‐step plan (interim analysis and final analysis) to test the success rate of the digital compression strategy group. Primiparous women aged ≥18 years with isolated vaginal or first‐degree perineal tears after spontaneous vaginal birth of a cephalic presenting term (≥37 weeks) neonate were randomly allocated to the conservative management (CM) group (digital compression if bleeding followed by suture if persistent bleeding) or a systematic suture (SS) group. The primary outcome was the success of the intervention 10 days after delivery, defined by pain as evaluated using a visual analog scale < 3, satisfactory healing defined by a REEDA score ≤ 2, and no bleeding or infection. Sexual well‐being was assessed at 2 and 6 months postpartum. Results: Among 861/2209 eligible women, 143 consenting women with a superficial perineal tear were randomized: 72 in the systematic suture group and 71 in the conservative management group. Success rate was 87.8% (90% CI [70.5‐93.54]) (42/55) in the systematic suture group vs 90% (90% CI [78.3‐93.8]) (53/61) in the conservative management group. The REEDA score was significantly higher in the systematic suture group (1.4 vs 0.9; P = 0.036). Perineal pain was significantly higher at day 1 in the systematic suture group (2.38 vs 1.69; P = 0.034). For the Female Sexual Functional Index score, no significant difference was found between the two groups at inclusion or at 2 and 6 months postpartum. Conclusions: Conservative management of superficial perineal tears shows an efficacy rate ≥90%. Women in the conservative management group had less pain at the 1st day follow‐up and lower REEDA scores at the 10th day follow‐up. [ABSTRACT FROM AUTHOR]

Background: Online exercise interventions can improve physical outcomes. Online supervised exercise program is more effective than unsupervised exercise program. Objectives: The aim of this study is to determine the effect of an online supervised exercise program on fasting blood glucose, body mass index (BMI), resilience and quality of life in older people with diabetes. Methods: This parallel group randomised controlled study included 70 older patients with Type 2 diabetes. Participants were divided into online supervised and unsupervised exercise training groups. Participants in the online‐supervised exercise group were given an online‐supervised exercise program 3 days a week for 6 weeks. Personal Information Form, Short Resilience Scale and Quality of Life Scale in Older People were used to collect data. In addition, fasting blood sugar BMI and values were measured. Results: According to the results of our study, while there was no significant difference between the pre‐and post‐training scores of the supervised and unsupervised groups on the Psychological Resilience Scale and Quality of Life Scale, it was observed that there was a significant difference in both groups according to time (p <.05). When the difference between the scores of the groups before and after the training was analysed according to time, a significant difference was observed between the online‐supervised and unsupervised exercise groups (p <.05). In addition, it was seen that there was a significant difference in the fasting blood sugar and BMI results of the online‐supervised exercise group according to time (p <.05). Conclusions: Online supervised exercise program decreases fasting blood sugar and BMI, increases psychological resilience and quality of life of older patients with Type 2 diabetes. Implication for practice: Online supervised exercise program may be an additional treatment that provides benefits for older people with diabetes who cannot participate in clinical‐based rehabilitation programs. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Background and aims: The inclusion of gaming disorder (GD) in the International Classification of Diseases 11th Revision (ICD‐11) has generated scholarly debate, including claims about its potential stigmatizing effects on the wider gaming population. The present study aimed to estimate the effect of addiction‐based and non‐addiction–based conceptualizations of problem gaming on stigma of gamers. Design: This preregistered experiment involved a 2 (health information: addiction‐related or non‐addiction‐related) × 3 (vignette: problem, regular or casual gamer) randomized, between‐subjects design. Setting: An international sample of participants was recruited via Prolific in June and July 2021. Participants: Participants were eligible (n = 1228) if they were aged 35 to 50 years, played video games for no more than 6 hours per week and did not endorse DSM‐5 or ICD‐11 criteria for GD. Intervention and comparator: Participants were provided with an explanation of problem gaming as related to either an addictive disorder (i.e. 'addiction' explanation) or personal choice and lifestyle factors (i.e. 'non‐addiction' explanation). Measurements The Attribution Questionnaire (AQ) and Universal Stigma Scale (USS) assessed stigma toward each gamer vignette. Vignettes described a problem gamer (with features of GD); a regular gamer (frequent gaming; some life interference); and a casual gamer (infrequent gaming; no life interference). Findings Problem gamer vignettes (mean [M] = 113.3; 95% CI = 111.5–115.4) received higher AQ stigma ratings than regular (M = 94.0; 95% CI = 91.9–95.9) and casual gamers (M = 80.1; 95% CI = 78.2–82.1). Although significant, the effect of health information type on AQ stigma ratings was negligible (addiction group [M = 97.6; 95% CI = 95.9–99.1], non‐addiction group [M = 94.1; 95% CI = 92.6–95.8]). However, the addiction information group scored lower on USS blame and responsibility than the non‐addiction information group with at least a small effect (99.1% confidence). Conclusions: Framing of problem gaming as an addictive disorder or non‐addictive activity appears to have a negligible effect on stigma of different gamers among middle‐age adults with minimal gaming experience. The concept of 'gaming addiction' seems unlikely to be an important influence on public stigma of gaming. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the impact of sub epidermal moisture (SEM) measurement and targeted pressure ulcer (PU) prevention, versus visual skin assessment and usual care, on mean SEM delta scores and early pressure ulcer development in acute hospital patients. A quantitative quasi‐experimental observational approach was used. A total of 149 at risk acute hospital patients took part, 78 treatment, and 71 control. SEM deltas were recorded daily for a maximum of 5 days using the SEM Scanner (Bruin Biometrics LLC, Los Angeles, California), on three sites: the sacrum, the right heel, and the left heel, with enhanced and targeted PU prevention interventions occurring in those with an elevated SEM delta scores in the treatment group. Intention to treat analysis was used to guide the final composition of results. SEM PU represents PU development as identified by 2 days of sustained abnormal SEM delta scores, ≥0.5, after day one. The mean number of days completed by participants was just under 4 days, participants had many different comorbidities, with the most common being: hypertension, cancer, and chronic obstructive pulmonary disease. Results showed that following the introduction of SEM guided targeted treatments, participants in the treatment group yielded a statistically significant reduction in mean SEM delta scores (MD: 0.49; 95% CI: 0.59, 0.39; P <.0001), and in the odds of developing a SEM PU (OR: 0.59, 95% CI: 0.24 to 1.00; P =.05). In the treatment group, none of the participants developed a visual PU, whereas, in the control group, 1.41% (n = 1/71) developed a visual PU. Based on all the results, the following is concluded, (1). There was a greater reduction in mean SEM delta scores among those cared for using SEM measurement and targeted PU prevention, versus those cared for using visual skin assessment and usual care, and (2). the mean SEM delta scores was statistically significantly lower at the study end for those who received targeted treatments based on abnormal SEM scores. More research is now needed in other and larger at‐risk groups to further validate what was found in this study. [ABSTRACT FROM AUTHOR]

Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self‐efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non‐significant increase in physical activity at 12 months (between‐group difference of 0.95 mg [95% CI: −0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self‐efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (−0.91, 95% CI: −1.74 to −0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. Conclusions: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi‐ethnic populations with a history of gestational diabetes. [ABSTRACT FROM AUTHOR]

Aims: To test separatel the efficacy of a web‐based and a peer‐based brief intervention (BI), compared with an expanded usual care control (EUC) group, among military reserve component members using alcohoI in a hazardous and harmful manner. Design: In the randomized controlled trial, participants were assigned to: [1] web‐based BI with web‐based boosters (BI + web), [2] web‐based BI with peer‐based boosters (BI + peer) or [3] enhanced usual care (EUC). Setting: Michigan, USA. Participants: A total of 739 Michigan Army National Guard members who reported recent hazardous alcohol use; 84% were male, the mean age was 28 years. Intervention: The BI consisted of an interactive program guided by a personally selected avatar. Boosters were delivered either on the web or personally by a trained veteran peer. A pamphlet, given to all participants, included information on hazardous alcohol use and military‐specific community resources and served as the EUC condition. Measurements The primary outcome measure was binge drinking episodes in the past 30 days, measured at 12 months after the BI. Findings All randomized participants were included in the outcome analyses. In adjusted analyses, BI + peer [beta = −0.43, 95% confidence interval (CI) = −0.56 to −0.31, P < 0.001] and BI + web (beta = −0.34, 95% CI = −0.46 to −0.23, P < 0.001) reduced binge drinking compared with EUC. Conclusion: This satudy was a web‐based brief intervention for hazardous alcohol use, with either web‐ or peer‐based boosters, reduced binge alcohol use among Army National Guard members. [ABSTRACT FROM AUTHOR]

Purpose: We tested the feasibility of survivorship care plan (SCP) delivery with/without a lay health educator (LHE) telephone‐delivered information session among rural cancer survivors, and their effects on health‐related self‐efficacy and knowledge of cancer history. Methods: Randomized trial of cancer survivors from 3 rural oncology clinics featuring either SCP alone (control) or SCP plus LHE‐delivered information session (intervention). Participants completed a questionnaire on health‐related self‐efficacy and knowledge of cancer‐specific medical history. Responses were compared to medical records for accuracy. SCPs were then mailed to participants. Approximately 5 months later, participants completed a follow‐up questionnaire. A subset of participants took part in subsequent qualitative interviews about their study experience. Findings: Of 301 survivors approached, 72 (23.9%) were randomized (mean age 66.4 years; 3.1 years from diagnosis; 62.5% female), and 65 (90.3%) completed the study. Global mental and physical health or self‐efficacy scores did not change significantly from baseline to follow‐up for either group. In exploratory analyses, self‐efficacy increased in participants with inadequate/marginal health literacy in the intervention arm (+0.7, 95% CI = 0.1‐1.2; P =.01). Accuracy of knowledge did not improve but was high at baseline (mean 76.0±14.5%). 60.1% and 48.4% of control and intervention participants, respectively, found SCPs definitely/somewhat useful. Qualitative data (n = 20) suggested that SCPs were helpful to patients when primary and oncology care were less integrated. Conclusions: An LHE‐delivered informational session was feasible but had limited benefit to rural cancer survivors versus delivery of SCP alone but may be of benefit to patients with low health literacy or with less integrated care. [ABSTRACT FROM AUTHOR]

Objective: Evaluate the efficacy and tolerability of prazosin for prophylaxis of headaches following mild traumatic brain injury in active‐duty service members and military veterans. Background: Prazosin is an alpha‐1 adrenoreceptor antagonist that reduces noradrenergic signaling. An open‐label trial in which prazosin reduced headache frequency in veterans following mild traumatic brain injury provided the rationale for this pilot study. Methods: A 22‐week parallel‐group randomized controlled trial which included 48 military veterans and active‐duty service members with mild traumatic brain injury–related headaches was performed. The study design was based on International Headache Society consensus guidelines for randomized controlled trials for chronic migraine. Following a pre‐treatment baseline phase, participants with at least eight qualifying headache days per 4 weeks were randomized 2:1 to prazosin or placebo. After a 5‐week titration to a maximum possible dose of 5 mg (morning) and 20 mg (evening), participants were maintained on the achieved dose for 12 weeks. Outcome measures were evaluated in 4‐week blocks during the maintenance dose phase. The primary outcome measure was change in 4‐week frequency of qualifying headache days. Secondary outcome measures were percent participants achieving at least 50% reduction in qualifying headache days and change in Headache Impact Test‐6 scores. Results: Intent‐to‐treat analysis of randomized study participants (prazosin N = 32; placebo N = 16) demonstrated greater benefit over time in the prazosin group for all three outcome measures. In prazosin versus placebo participants, reductions from baseline to the final rating period for 4‐week headache frequency were −11.9 ± 1.0 (mean ± standard error) versus −6.7 ± 1.5, a prazosin minus placebo difference of −5.2 (−8.8, −1.6 [95% confidence interval]), p = 0.005 and for Headache Impact Test‐6 scores were −6.0 ± 1.3 versus +0.6 ± 1.8, a difference of −6.6 (−11.0, −2.2), p = 0.004. The mean predicted percent of participants at 12 weeks with ≥50% reduction in headache days/4 weeks, baseline to final rating, was 70 ± 8% for prazosin (21/30) versus 29 ± 12% for placebo (4/14), odds ratio 5.8 (1.44, 23.6), p = 0.013. The trial completion rate of 94% in the prazosin group (30/32) and 88% in the placebo group (14/16) indicated that prazosin was generally well tolerated at the administered dose regimen. Morning drowsiness/lethargy was the only adverse effect that differed significantly between groups, affecting 69% of the prazosin group (22/32) versus 19% of the placebo group (3/16), p = 0.002. Conclusions: This pilot study provides a clinically meaningful efficacy signal for prazosin prophylaxis of posttraumatic headaches. A larger randomized controlled trial is needed to confirm and extend these promising results. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effect of a Nordic hamstring exercise or Diver hamstring exercise intervention on biceps femoris long head, semitendinosus and semimembranosus muscle's fascicle length and orientation through diffusion tensor imaging (DTI) with magnetic resonance imaging. Methods: In this three‐arm, single‐center, randomized controlled trial, injury‐free male basketball players were randomly assigned to a Nordic, Diver hamstring exercise intervention or control group. The primary outcome was the DTI‐derived fascicle length and orientation of muscles over 12 weeks. Results: Fifty‐three participants were included for analysis (mean age 22 ± 7 years). Fascicle length in the semitendinosus over 12 weeks significantly increased in the Nordic‐group (mean [M]: 20.8 mm, 95% confidence interval [95% CI]: 7.8 to 33.8) compared with the Control‐group (M: 0.9 mm, 95% CI: −7.1 to 8.9), mean between‐groups difference: 19.9 mm, 95% CI: 1.9 to 37.9, p = 0.026. Fascicle orientation in the biceps femoris long head over 12 weeks significantly decreased in the Diver‐group (mean: ‐2.6°, 95% CI: −4.1 to −1.0) compared with the Control‐group (mean: −0.2°, 95% CI: −1.4 to 1.0), mean between‐groups difference: ‐2.4°, 95% CI: −4.7 to −0.1, p = 0.039. Conclusion: The Nordic hamstring exercise intervention did significantly increase the fascicle length of the semitendinosus and the Diver hamstring exercise intervention did significantly change the orientation of fascicles of the biceps femoris long head. As both exercises are complementary to each other, the combination is relevant for preventing hamstring injuries. [ABSTRACT FROM AUTHOR]

Background and Aims: Excessive cannabis use may lead to lower educational attainment. However, this association may be due to confounders and reverse causality. We tested the potential causal relationship between cannabis use disorder (CUD) or life‐time cannabis use (LCU) and educational attainment. Design: Bidirectional two‐sample Mendelian randomization (MR) study was conducted. Our primary method was inverse‐variance weighted (IVW) MR, with a series of sensitivity analyses. Multivariable MR (MVMR) was performed to estimate any direct effect independent of intelligence, smoking initiation or attention deficit hyperactivity disorder (ADHD). Setting and participants: European ancestry individuals. The sample sizes of the genome‐wide association study ranged from 55 374 to 632 802 participants. Measurements Genetic variants of CUD, LCU or educational attainment. Findings Using univariable MR, we found evidence of a potential causal effect of genetic liability to CUD on a lower educational attainment [MR, 95% confidence interval (CI)inverse variance weighted (IVW) = −1.2 month (−1.9 month, −0.5 month); P = 0.0008]. However, we found no evidence of an effect of genetic liability to LCU on educational attainment [MR, 95% CIIVW = 0.5 month (−1.5 month, 2.6 month), P = 0.6032]. Reverse direction analysis suggested that genetic liability to higher educational attainment had a potential causal effect on lower risk of CUD [odds ratio (OR), 95% CIIVW = 0.39 (0.29, 0.52), P = 1.69 × 10−10]. We also found evidence of potential causal effect from genetic liability to higher educational attainment to higher risk of LCU [OR, 95% CIIVW = 1.35 (1.11, 1.66), P = 0.0033]. Conclusions: Genetic liability to cannabis use disorder may lead to lower educational attainment. Genetic liability to higher educational attainment may also lead to higher life‐time cannabis use risk and lower cannabis use disorder risk. However, the bidirectional effect between cannabis use disorder and educational attainment may be due to shared risk factors (e.g. attention‐deficit hyperactivity disorder). [ABSTRACT FROM AUTHOR]

Aim: To examine the effects of breastfeeding support given by video call on anxiety, breastfeeding self‐efficacy, and newborn outcomes. Methods: We conducted a randomized controlled experimental trial with 72 women and their babies. Participants were randomly assigned to the intervention (video call) group (VCG: standard care + video call) and control group (CG: standard care). The primary outcomes of this study were the mean postpartum maternal anxiety level and the mean breastfeeding self‐efficacy level. The secondary outcome was neonatal outcomes. This study followed the CONSORT (Consolidated Standards of Reporting Trials) checklist. Results: Women in VCG had lower anxiety levels than the CG at postpartum 2 weeks (mean difference [MD] 25.42, p =.000) and 1 month (MD 47.72, p =.000). The breastfeeding self‐efficacy level of women in the VCG was higher than the CG at postpartum 2 weeks (MD 13.18, p =.007) and 1 month (MD 10.1, p =.001). The newborns in VCG had higher weight gain and daily breastfeeding frequency than the CG at the postpartum second week (MD 9.64, p =.001, MD 2.88, p =.000; respectively) and 1 month (MD 47.16, p =.000, MD 2.98, p =.000; respectively). There were lower rates of challenges of breastfeeding, hyperbilirubinemia, and feeding with formula in VCG than CG at the postpartum second week (p =.043, p =.043, p =.039; respectively). Conclusions: Breastfeeding support via video calling has positive effects on maternal anxiety, breastfeeding self‐efficacy, and newborn health. Postpartum caregivers may benefit from video calling for breastfeeding support. [ABSTRACT FROM AUTHOR]

Background: Daily skin‐to‐skin contact (SSC) during early infancy fosters the long‐term development of children born preterm. This is the first randomized controlled trial assessing the potential beneficial effects of daily SSC on executive functioning and socio‐emotional behavior of children born full‐term. Whether children of mothers who experienced prenatal stress and anxiety benefitted more from SSC was also explored. Methods: Pregnant women (N = 116) were randomly assigned to a SSC or care‐as‐usual (CAU) condition. Women in the SSC condition were instructed to perform one hour of SSC daily from birth until postnatal week five. Prenatal stress was measured with questionnaires on general and pregnancy‐specific stress and anxiety completed by the mothers in gestational week 37. At child age three, mothers filled in questionnaires on children's executive functioning, and externalizing and internalizing behavior. Analyses were performed in an intention‐to‐treat (ITT), per‐protocol, and dose–response approach. Netherlands Trial Register: NL5591. Results : In the ITT approach, fewer internalizing (95% CI = 0.11–1.00, U = 2148.50, r =.24, p =.001) and externalizing (95% CI = 0.04–2.62, t = 2.04, d = 0.38, p =.04) problems were reported in the SSC condition compared to the CAU condition. Multivariate analyses of variance did not show group differences on executive functioning. Additional analyses of covariance showed no moderations by maternal prenatal stress. Conclusions: Current findings indicate that early daily SSC in full‐term infants may foster children's behavioral development. Future replications, including behavioral observations of child behavior to complement maternal reports, are warranted. [ABSTRACT FROM AUTHOR]

Background: 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non‐inferiority of OST compared to multi‐session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi‐center, non‐inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university‐based CYP well‐being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non‐inferiority and a nested cost‐effectiveness evaluation was assessed 6‐months post‐randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal‐based outcome measure, and EQ‐5DY and CHU‐9D, collected blind at baseline and six‐months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention‐to‐treat (ITT) and per‐protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale‐adjusted mean difference for CBT compared to OST ‐0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non‐inferiority limit of 0.4, suggesting that OST is non‐inferior to CBT. No between‐group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost‐saving alternative. [ABSTRACT FROM AUTHOR]

Background and aims: Alcohol use disorder (AUD) is a chronic disorder with high relapse rates. There are currently few clinical trials of high frequency repetitive transcranial magnetic stimulation (HF‐rTMS) to reduce alcohol use among AUD patients, and results are mixed. The current study tested the effect of 10 add‐on sessions of HF‐rTMS over the right dorsolateral pre‐frontal cortex (DLPFC) on alcohol use and craving. Design: Single‐center, single blind sham‐controlled parallel‐group RCT (n = 80), with 3 and 6 months follow‐up. Setting: Clinical treatment center in Amsterdam, the Netherlands. Participants: Eighty detoxified and abstinent AUD inpatients in clinical treatment (20 females, average age = 44.35 years). Intervention: Ten sessions of active or sham HF‐rTMS (60 10 Hz trains of 5 sec at 110% motor threshold) over the right DLPFC on 10 consecutive work‐days. Measurements The primary outcome measure is the number of abstinent days over 6‐month follow‐up (FU). Secondary outcome measures are craving over 6‐month FU (alcohol urge questionnaire and obsessive‐compulsive drinking scale), time to first relapse over 6‐month FU and grams of alcohol consumed over 6‐month FU. Additional outcome measures: full abstinence over 6‐month FU and treatment success over 12‐month FU. Findings HF‐rTMS did not affect the number of abstinent days over 6 months FU [sham = 124 ± 65.9 days, active = 115 ± 69.8 days, difference: 9 days, 95% confidence interval (CI) = Poisson model: 0.578–3.547]. Moreover, HF‐rTMS did not affect craving (AUQ/OCDS) (sham = 15.38/5.28, active = 17.48/4.75, differences = 2.1/−0.53, 95% CI mixed‐effects model = −9.14 to 2.07/−1.44 to 2.40). Conclusions: There was no clear evidence that high‐frequency repetitive transcranial magnetic stimulation over the right dorsolateral pre‐frontal cortex treatment has a long‐term positive effect on alcohol use or craving as add‐on treatment for alcohol use disorder. High treatment response at 6‐month follow‐up could have limited the possibility to find an effect. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of a clinical‐based oral function intervention on oral function and care behaviours in older patients with mild dementia. Method: Participants were randomly assigned to the experimental group (EG) and control group (CG). Both groups received a leaflet on oral health‐related knowledge, and the EG also received an oral function intervention, which was a brief one‐on‐one lesson concerning oral exercise and preventive oral care. Oral exercise included turning the head, pouting lips, bulging cheeks, stretching tongue, articulation exercise and salivary gland massages. A reminder phone call was made every 2 weeks. Perceived xerostomia and dysphagia, plaque index (PI), Winkel tongue‐coating index (WTCI), repetitive saliva‐swallowing test (RSST), oral diadochokinesis (DDK) and oral care behaviours were recorded at baseline and at 3‐month follow‐up. Generalised Estimating Equations (GEE) were used to analyse the indicated effects. Results: The EG (n = 59) exhibited greater improvement to the CG (n = 55) in RSST [β = 0.7; effect size (ES) = 0.45], the syllables /pa/ (β = 3.1; ES = 0.37) and /ka/ (β = 2.7; ES = 0.40) in oral DDK, PI (β = −0.2; ES = 0.52) and WTCI (β = −0.8; ES = 0.38). Moreover, the EG exhibited better preventive behaviours in regular dental visits [adjusted odds ratio (aOR) = 2.2], daily mouth cleaning frequency (aOR = 1.6) and mouth cleaning before sleep (aOR = 1.3). Conclusion: The brief clinical‐based intervention was effective in improving the swallowing function, oral DDK and plaque control of older patients with mild dementia at 3‐month follow‐up. [ABSTRACT FROM AUTHOR]