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Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [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]

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]

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]

Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [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]

Objectives Lipoatrophy is a long-term adverse effect of some antiretrovirals that affects quality of life, compromises adherence and may limit the clinical impact of HIV treatments. This paper explores the effect of tenofovir/emtricitabine ( TDF/ FTC) on the amount of limb fat in patients with virological suppression. Methods A randomized, prospective clinical trial was performed to compare continuation on a zidovudine/lamivudine ( ZDV/3TC)-based regimen with switching to a TDF/ FTC-based regimen in terms of the effect on limb fat mass as assessed by DEXA over a 72-week period. Results Eighty patients were included (39 in the TDF/ FTC arm and 41 in the ZDV/3 TC arm) and 73 completed the study (37 and 36, respectively). In the switch arm, limb fat increased by a median of 540 g from baseline ( P = 0.022), while in the ZDV/3TC arm it decreased by a median of 379 g ( P = 0.112; p between groups = 0.007). Subjects with baseline limb fat ≤ 7200 g, previous time on ZDV > 5 years or a body mass index > 25 kg/m2 experienced higher limb fat gains than other subjects, and these differences were statistically significant. Haemoglobin increased by a median of 1.0 g/d L in the TDF/ FTC arm ( P < 0.001) and remained unchanged in the ZDV/3TC arm (p between groups = 0.0002). There were no significant differences between groups in other secondary endpoints (body weight, total body and trunk fat content, total body bone mineral density, laboratory parameters, CD4 cell count and viral load). Conclusions Switching from a ZDV/3TC-based to a TDF/ FTC-based regimen led to a statistically significant improvement in limb fat, in contrast to the progressive loss of limb fat in subjects continuing ZDV/3TC. [ABSTRACT FROM AUTHOR]

Objective This paper explores the lessons learned from a series of three randomized controlled trials that included 498 community-living frail older adults (≥65 years) using home care services in Southern Ontario, Canada. Each study was designed to evaluate the effectiveness of different multi-component nurse-led health promotion and disease prevention (HPDP) interventions. Methods The nurse-led HPDP interventions were 6- or 12-month multi-component and evidence-based strategies targeting known risk factors for functional decline and frailty. Across the three studies, a common approach was used to measure the change in health-related quality of life (HRQOL) (SF-36) and the costs of use of health services (Health and Social Services Utilization Inventory) from baseline to the end of the intervention. Results The main lesson learned from the three studies is that nurse-led HPDP interventions for frail older home care clients provide greater improvements in HRQOL compared with usual home care. Such approaches are highly acceptable to this population and can be implemented using existing home care resources. Nurse-led HPDP interventions should include multiple home visits, multidimensional screening and assessment, multi-component evidence-based HPDP strategies, intensive case management, inter-professional collaboration, providers with geriatric training and experience, referral to and coordination of community services, and theory use. Conclusion The results of the three trials underscore the need to reinvest in nurse-led HPDP interventions in home care to optimize HRQOL and promote ageing in place in the target population of frail older adults. More studies are needed to evaluate the effectiveness of additional nurse-led HPDP interventions in other contexts and settings. [ABSTRACT FROM AUTHOR]

Objective This paper presents the final analysis of once-daily darunavir/ritonavir ( DRV/r) vs. lopinavir/ritonavir ( LPV/r) in treatment-naïve HIV-1-infected adults. Methods ARTEMIS ( AntiRetroviral Therapy with TMC114 ExaMined In naïve Subjects; NCT00258557) was a randomized, open-label, phase- III, 192-week trial. Patients were stratified by baseline HIV-1 RNA and CD4 count, and randomized to once-daily DRV/r 800/100 mg or LPV/r 800/200 mg total daily dose (either once or twice daily) plus tenofovir/emtricitabine. Results Of 689 randomized patients receiving treatment ( DRV/r: 343; LPV/r: 346), 85 and 114 patients in the DRV/r and LPV/r arms, respectively, had discontinued by week 192. Noninferiority was shown in the primary endpoint of virological response ( HIV-1 RNA < 50 copies/ mL) [ DRV/r: 68.8%; LPV/r: 57.2%; P < 0.001; intent to treat ( ITT)/time to loss of virological response; estimated difference in response 11.6% (95% confidence interval 4.4-18.8%)]. Statistical superiority in virological response of DRV/r over LPV/r was demonstrated for the primary endpoint ( P = 0.002) and for the ITT non-virological-failure-censored analysis (87.4% vs. 80.8%, respectively; P = 0.040). No protease inhibitor ( PI) primary mutations developed and only low levels of nucleoside reverse transcriptase inhibitor ( NRTI) resistance developed in virological failures in both groups. Significantly fewer discontinuations because of adverse events were observed with DRV/r (4.7%) than with LPV/r (12.7%; P = 0.005). Grade 2-4 treatment-related diarrhoea was significantly less frequent with DRV/r than with LPV/r (5.0% vs. 11.3%, respectively; P = 0.003). DRV/r was associated with smaller median increases in total cholesterol and triglyceride levels than LPV/r. Changes in low- and high-density lipoprotein cholesterol were similar between groups. Similar increases in aspartate aminotransferase and alanine aminotransferase for DRV/r and LPV/r were observed. Conclusion Over 192 weeks, once-daily DRV/r was noninferior and statistically superior in virological response to LPV/r, with a more favourable gastrointestinal profile, demonstrating its suitability for long-term use in treatment-naïve patients. [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]

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]

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]

Exclusive breastfeeding (EBF) for the first 6 months has established benefits, yet had slow improvements globally. Little is known about electronic job aid‐assisted counselling to support EBF. As a secondary outcome of a cluster randomized controlled trial in Bangladesh, we assessed the effect of electronic job aid‐supported nutrition counselling and practical demonstration on EBF. We randomized pregnant women to one of five study arms in the trial and followed mother–child dyads until 2 years of age. Community health workers (CHWs) provided breastfeeding counselling with or without prenatal and complementary nutrient supplements in all four intervention arms. The comparison arm continued with the usual practice where mothers could receive nutrition counselling at routine antenatal and postnatal care, and during careseeking for childhood illnesses. We assessed breastfeeding indicators at birth and monthly until the child was 6 months old, in both intervention and comparison arms. To evaluate the effect of nutrition counselling on breastfeeding, we combined all four intervention arms and compared them with the comparison arm. Intervention newborns had half the risk (relative risk [RR]: 0.54, 95% confidence interval [CI]: 0.39, 0.76) of receiving prelacteal feeds than those in the comparison arm. EBF declined steeply in the comparison arm after 3 months of age. EBF was 16% higher in the intervention than the comparison arm at 4 months (RR: 1.16, 95% CI: 1.08, 1.23) and 22% higher at 5 months of age (RR: 1.22, 95% CI: 1.12, 1.33). Maternal background and household characteristics did not modify the intervention effect, and we observed no difference in EBF among caesarean versus vaginal births. Breastfeeding counselling and practical demonstration using an electronic job aid by CHWs are promising interventions to improve EBF and are scalable into existing community‐based programmes. Key messages: Using an electronic job aid, repeated, one‐to‐one counselling and practical demonstration to mothers by locally recruited CHWs reduced prelacteal feeding and improved EBF practice by delaying the early introduction of complementary food.The positive effect of counselling on EBF remains similar with or without nutrient supplementation.Electronic job aid supported counselling to promote breastfeeding should be integrated into existing community‐based maternal and child health programmes. [ABSTRACT FROM AUTHOR]

Aims: To examine the effects of e‐learning on intimate partner violence (IPV) knowledge, preparatory/reinforcing behaviors for supporting IPV victims, and IPV screening of midwives and nurses. Methods: Participants were randomly assigned to the intervention group (IG: e‐learning) and control group (CG: no e‐learning). The primary outcome was the mean change in knowledge score. The secondary outcomes were the mean number of types of practiced preparatory/reinforcing behaviors and the proportions of participants who practice screening. Unpaired t tests were performed in intention‐to‐treat analysis. Results: Of the 88 participants, 45 were randomly assigned to the IG and 43 to the CG. For the post‐1‐test, the IG had a mean change in the knowledge score of 8.5 points with a significant difference from the 1.4 points in the CG (mean difference [MD] 7.1, 95% CI [4.1, 10.1]). The mean change between the pre‐test and the post‐2‐test was significantly larger in the IG (7.9 points) than in the CG (1.3 points) (MD 6.6, 95% CI [3.3, 9.9]). The mean number of types of practiced behaviors at the post‐1‐test and post‐2‐test was significantly higher in the IG than in the CG (MD 1.4, 95% CI [0.1, 2.8]). There was no significant difference in the proportions of participants who practice screening between the two groups postintervention. Conclusions: The e‐learning effectively improved knowledge and promoted preparatory/reinforcing behaviors. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [ABSTRACT FROM AUTHOR]

Child undernutrition in Cambodia is a persistent public health problem requiring low‐cost and scalable solutions. Rising cellphone use in low‐resource settings represents an opportunity to replace in‐person counselling visits with phone calls; however, questions remain on relative effectiveness. Our objective was to evaluate the impact of two options for delivering a World Vision infant and young child feeding (IYCF) counselling programme: (1) traditional Positive Deviance/Hearth (PDH) programme with in‐person visits or (2) PDH with Interactive Voice Calling (PDH‐IVC) which integrates phone calls to replace 62.5% of face‐to‐face interaction between caregivers and volunteers, compared to the standard of care (SOC). We conducted a longitudinal cluster‐randomised controlled trial in 361 children 6–23 months. We used an adjusted difference‐in‐difference approach using baseline, midline (3 months) and endline (12 months) surveys to evaluate the impact on child growth among the three groups. At baseline, nearly a third of children were underweight, and over half were food insecure. At midline the PDH group and the PDH‐IVC groups had improved weight‐for‐age z‐scores (0.13 DID, p = 0.011; 0.13 DID, p = 0.02, respectively) and weight‐for‐height z‐score (0.16 DID, p = 0.038; 0.24 DID, p = 0.002), relative to SOC. There were no differences in child height‐for‐age z‐scores. At endline, the impact was sustained only in the PDH‐IVC group for weight‐for‐age z‐score (0.14 DID, p = 0.049), and the prevalence of underweight declined by 12.8 percentage points (p = 0.036), relative to SOC. Integration of phone‐based IYCF counselling is a potentially promising solution to reduce the burden of in‐person visits; however, the modest improvements suggest the need to combine it with other strategies to improve child nutrition. [ABSTRACT FROM AUTHOR]

In this study, we investigated the validity of a stealth assessment of physics understanding in an educational game, as well as the effectiveness of different game‐level delivery methods and various in‐game supports on learning. Using a game called Physics Playground, we randomly assigned 263 ninth‐ to eleventh‐grade students into four groups: adaptive, linear, free choice and no‐treatment control. Each condition had access to the same in‐game learning supports during gameplay. Results showed that: (a) the stealth assessment estimates of physics understanding were valid—significantly correlating with the external physics test scores; (b) there was no significant effect of game‐level delivery method on students' learning; and (c) physics animations were the most effective (among eight supports tested) in predicting both learning outcome and in‐game performance (e.g. number of game levels solved). We included student enjoyment, gender and ethnicity in our analyses as moderators to further investigate the research questions. [ABSTRACT FROM AUTHOR]

Childhood obesity has been associated with consumption of energy‐dense foods such as caloric beverages and fast foods. Many low‐ and middle‐income countries like Bangladesh are now experiencing a rising problem of noncommunicable diseases along with the long‐standing problem of stunting and undernutrition. WASH Benefits Bangladesh was a large community‐based cluster randomized controlled trial conducted in rural Bangladesh. Study clusters were randomized into seven arms: single nutrition (N); water (W); sanitation (S); hygiene (H); combined water, sanitation, and hygiene (WSH); WSH and nutrition (N + WSH); and a double sized control (C). Nutrition intervention messages included four promotional components: maternal nutrition, breastfeeding, complementary feeding, and lipid‐based nutrient supplements. The World Health Organization infant food frequency questionnaire (24‐hr recall and 7‐day recall) was administered at Year 1 and Year 2 of intervention. The likelihood of any snack food consumption was significantly lower (odds ratio 0.37: 95% confidence interval [0.28, 0.49]) in the nutrition intervention arms compared to the control arm in Year 2 follow‐up. In addition, in the water intervention arm, fewer children (about 50% less) consumed soft drinks, but not the other sugar‐sweetened beverages, compared with control in Year 2. There were no other differences between groups. Simple messages about balanced diet and feeding family foods were effective in lowering commercially produced snack food consumption of the young children in low‐income rural communities of Bangladesh. Provision of safe water apparently encouraged mothers to reduce offering unhealthy beverages to the young children. [ABSTRACT FROM AUTHOR]

Prenatal nutritional supplements may improve birth outcomes. This study aims to examine the effect of prenatal lipid‐based nutrient supplements (LNS), compared with iron and folic acid (IFA), on general newborn physical condition and feeding behaviours. We conducted a cluster‐randomized effectiveness trial that enrolled 4,011 pregnant women at ≤20 gestational weeks. LNS and IFA were provided to women in 48 and 16 clusters, respectively, for daily consumption until delivery. We collected data on household socio‐economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72 hr of delivery. We analysed intervention effects on these secondary outcomes using mixed models with analysis of covariance for continuous outcomes and logistic regression for dichotomous outcomes. Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr. If the mother perceived her infant to be healthy, EIBF was more likely (OR [95% CI]: 2.08 [1.46, 2.97]) and frequency of breastfeeding in the first 24 hr was greater (mean difference [95% CI]: 3.0 [1.91, 4.01]), but there was no difference in exclusive breastfeeding in the first 24 hr. Newborn condition and early breastfeeding practices were not affected by giving mothers prenatal LNS versus IFA. However, early breastfeeding practices were related to maternal perception of her newborn's condition. Thus, interventions to improve breastfeeding practices for newborns with poorer perceived health status may be useful. [ABSTRACT FROM AUTHOR]

Background: Pre‐labour rupture of membranes (PROM) at term is a common event with early induction of labour reducing infectious morbidity without increasing the caesarean rate. Syntocinon is commonly used for induction but prostaglandins are also routinely used. Large studies have shown no difference in the maternal and neonatal outcomes with either method. Aim: To assess the safety and efficacy of vaginal prostaglandin (PG) compared to syntocinon for induction of labour in term‐PROM. Method: This was a single‐centre randomised controlled trial at Ipswich Hospital of women presenting at ≥37 weeks gestation with PROM. Women were randomised and managed in labour as per local guidelines. Analysis was by intention to treat. Results: One hundred and eighty‐four women were recruited, 90 in the PG group and 94 in the oxytocin group. Women in both arms were of similar demographics and 53% of women in the PG group did not require any oxytocin. There was a statistically significant lower incidence of fetal heart rate abnormality in the PG group, 4.4% versus 12.8%. There was no difference in epidural use, caesarean section, maternal infection, admission to special care nursery or neonatal sepsis. Time to onset of labour was significantly longer in the PG group, 25.7 h versus 19.7 h but with no difference in the length of first stage. Maternal satisfaction was high in both groups with no significant difference in breastfeeding rates. Conclusion: Induction of labour with oxytocin or vaginal prostaglandins are safe and efficacious options for women in the context of PROM at term. [ABSTRACT FROM AUTHOR]

Abstract: Background: Parent‐reported measures of early communication have limitations for use with infants experiencing adversity. Observational measures of early non‐verbal and verbal communicative behaviours and mother–child turn‐taking may provide a complementary method of capturing early communication skills for these children. Aims: To explore the predictive validity of verbal and non‐verbal behaviours and mother–child conversational turn‐taking (fluency and connectedness) at child age 12 months in relation to language measures at 24 and 36 months in a cohort of infants experiencing adversity. Methods & Procedures: Pregnant women experiencing adversity were recruited from maternity hospitals in Australia. At 12 months, 190 infants were videoed during mother–child free‐play. Verbal and non‐verbal communicative behaviours and fluency and connectedness were measured from the 12‐month videos. Predictive validity of 12‐month behaviours was calculated in relation to mean length of utterance and number of unique words at 24 months and Clinical Evaluation of Language Fundamentals Preschool—Second Edition (CELF‐P2) Core Language scores at 36 months. Outcomes & Results: All 12‐month behaviours had adequate specificity but poor sensitivity when compared with other predictive validity studies using published early language measures. However, in adjusted regression models, fluency and connectedness and verbal behaviours at 12 months predicted unique words at 24 months. Fluency and connectedness also predicted CELF‐P2 scores at 36 months. Conclusions & Implications: Findings reconfirm the difficulty in early identification of children at risk of later language difficulties. All 12‐month measures were more accurate at identifying those children who will have better language than those children who will not. As fluency and connectedness was the only measure to predict 24‐ and 36‐month language in adjusted regression models, it may be an important factor to consider when measuring early language skills for infants experiencing adversity. Future research could combine observational measures of early communication and fluency and connectedness with other predictors of language to try to increase prediction accuracy. [ABSTRACT FROM AUTHOR]

Abstract: Background: Identifying risk and protective factors for language development informs interventions for children with developmental language disorder (DLD). Maternal responsive and intrusive communicative behaviours are associated with language development. Mother–child interaction quality may influence how children use these behaviours in language learning. Aims: To identify (1) communicative behaviours and interaction quality associated with language outcomes; (2) whether the association between a maternal intrusive behaviour (directive) and child language scores changed alongside a maternal responsive behaviour (expansion); and (3) whether interaction quality modified these associations. Methods & Procedures: Language skills were assessed at 24, 36 and 48 months in 197 community‐recruited children who were slow to talk at 18 months. Mothers and 24‐month‐olds were video‐recorded playing at home. Maternal praise, missed opportunities, and successful and unsuccessful directives (i.e., whether followed by the child) were coded during a 10‐min segment. Interaction quality was rated using a seven‐point fluency and connectedness (FC) scale, during a 5‐min segment. Linear regressions examined associations between these behaviours/rating and language scores. Interaction analysis and simple slopes explored effect modification by FC. Outcomes & Results: There was no evidence that missed opportunities or praise were associated with language scores. Higher rates of successful directives in the unadjusted model and unsuccessful directives in the adjusted model were associated with lower 24‐month‐old receptive language scores (e.g., unsuccessful directives effect size (ES) = −0.41). The association between unsuccessful directives and receptive language was weaker when adjusting for co‐occurring expansions (ES = −0.34). Both types of directives were associated with poorer receptive and expressive language scores in adjusted models at 36 and 48 months (e.g., unsuccessful directive and 48‐month receptive language, ES = −0.66). FC was positively associated with 24‐, 36‐ and 48‐month language scores in adjusted models (e.g., receptive language at 24 months, ES = 0.21, at 48 months, ES = 0.18). Interaction analysis showed the negative association between successful directives and 24‐month receptive language existed primarily in poorly connected dyads with low FC levels. Conclusions & Implications: These findings illustrate the effects of the combined interaction between different maternal communicative behaviours and features of the interaction itself on child language development, and the need to consider both in research and practice. Whilst more intrusive directives were associated with poorer language scores, this association attenuated when adjusting for co‐occurring responsive expansions, and the association was strongest for children in lower quality interactions. This work may inform clinical practice by helping clinicians target the most appropriate communicative behaviours for specific mother–child dyads. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND Teen pregnancy rates and related risks remain elevated among Latino teens. We tested the impact on youth sexual behaviors of a brief, culturally targeted, bilingual media intervention designed for parents of young adolescents. METHODS Salud y éxito ( Health & Success) uses dramatic audio stories to model positive parenting practices. After completing classroom surveys, 27 urban schools in the Northeast and Southwest serving low-income Latino communities were randomized so that all families of seventh grade students were sent either: (1) booklets on healthy eating and exercise; (2) Salud-50, where families either received booklets or the intervention, or (3) Salud-100, where all families received the intervention. Postintervention follow-up surveys were conducted at 3- and 12-months. Multilevel analyses tested intervention effects, controlling for sociodemographics. RESULTS Compared with controls, at 12-months postintervention (8th grade spring), youth in Salud-100 report lower sexual risks (touching, AOR 1.46, CI 1.19-0.84, p < .001; lifetime sex ( AOR 0.74, CI 0.61-0.90, p < .01); and sex intentions ( AOR 0.78, CI 0.63-0.96, p < .05). Consistent with a dose-response, Salud-50 results are between those from Salud-100 and control schools. CONCLUSIONS Salud y éxito is an effective parenting intervention that can augment school-based health and sexuality education and help Latino parents support their children during early adolescence. [ABSTRACT FROM AUTHOR]

Feeding behaviors have an important impact on children's nutritional status and are essential to consider when implementing nutrition programs. The objective of this study was to explore and compare feeding behaviors related to supplementary feeding with corn-soy blends (CSB) and lipid-based nutrient supplements (LNS) based on best practice feeding behaviors. The study was conducted as part of a randomized controlled trial assessing the effectiveness of new formulations of CSB and LNS and comprised 1,546 children from 6 to 23 months. The study included a mixed methods approach using questionnaires, focus group discussions and home visits and interviews with a subsample of 20 caretakers of trial participants. We found that LNS, compared to CSB, were more likely to be mixed into other foods (OR [95% CI] 1.7 [1.3-2.2], p = <.001), served with a meal (OR [95% CI] 1.6 [1.1-2.3], p = <.018)or between meals (OR [95% CI] 1.5 [1.1-1.9], p = <.005), and fed using an encouraging feeding style (mean difference in percentage points [95% CI] 23% [6%:40%], p = .01). CSB were more likely to be fed using a forced feeding style (mean difference in percentage points [95% CI] 18% [3%:33%], p = .02) and were often observed to be served unprepared. The main differences in feeding behaviors between the two diet groups were linked to how and when supplements were served. Educational instructions should therefore be adapted according to the supplement provided; when providing CSB, efforts should be made to promote an encouraging feeding style, and emphasis should be made to ensure preparations are made according to recommendations. [ABSTRACT FROM AUTHOR]

Cardiac disease and type 2 diabetes are prevalent diseases globally. Cardiac rehabilitation and diabetes self-management programs empower patients' self-management to improve their health outcomes. However, inappropriate delivery modes and continuing low participation rates indicate some programs are less than optimal. A previous study demonstrated the feasibility of incorporating telephone and text messages into a cardiac-diabetes self-management program in Australia; however, the program did not specifically address patients' cultural backgrounds. This current study used a randomized blocked design to evaluate short-term efficacy of the cardiac-diabetes self-management program incorporating telephone and text-messaging across different cultural contexts in Australia and Taiwan in comparison to usual care. No significant differences between groups were observed for outcomes of self-care behavior, self efficacy, knowledge and health-related quality of life, with patients in both groups demonstrating improvements. Patient-reported outcomes indicated some evidence of an interaction effect between country of origin and group allocation. Findings indicated an improved tendency of outcome measures between the baseline and follow-up assessments within usual care and intervention groups. Further research is required to clarify components of the program work for each cultural group. [ABSTRACT FROM AUTHOR]

ABSTRACT Background As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. Aims To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers ( FC) in delirium management following cardiac surgery. Design A randomized pilot study. Methods A total of 30 patient/ FC dyads were recruited and randomized to usual care ( n = 14) or intervention ( n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. Results The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with control group patients ( p = 0·01). Mean delirium severity scores showed similar trajectories on days 1, 2 and 3 in both groups. Conclusion The mentoring intervention was acceptable and feasible and shows promising results in improving patients and FC outcomes. Relevance to clinical practice Nurses should involve, if willing, FC to participate in activities that optimise patient well-being FC to use recognized delirium management strategies like reorientation and reassurance. [ABSTRACT FROM AUTHOR]

Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow-ups. Setting United States. Participants Smokers ( n = 94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output ( n = 48; abstinent contingent group, AC), or based on submitting CO samples ( n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. Conclusions A contingency management/financial incentive program delivered via the internet improved short-term abstinence rates compared with an internet program without the incentives. [ABSTRACT FROM AUTHOR]

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol −0.71, MMN −0.63, PE −0.64, PE + MMN −0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (−0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Aim To assess the impact on fear of hypoglycaemia and treatment satisfaction with an artificial pancreas system used for 2 consecutive months, as well as participant acceptance of the artificial pancreas system. Methods In a randomized crossover trial patient-related outcomes associated with an evening-and-night artificial pancreas and sensor-augmented pump therapy were compared. Both intervention periods lasted 8 weeks. The artificial pancreas acceptance questionnaire (range 0-90, higher scores better), Hypoglycaemia Fear Survey II (range 0-72, higher scores worse) and Diabetes Treatment Satisfaction Questionnaire (range 0-36, higher scores better) were completed by 32 participants. Semi-structured interviews were conducted after study completion in a subset of six participants. Outcomes were compared using a repeated-measures anova model or paired t-test when appropriate. Results The total artificial pancreas acceptance questionnaire score at the end of the artificial pancreas period was 69.1 ( sd 14.7; 95% CI 63.5, 74.7), indicating a positive attitude towards the artificial pancreas. No significant differences were found among the scores at baseline, end of sensor-augmented pump therapy period or end of the artificial pancreas period with regard to fear of hypoglycaemia [28.2 ( sd 17.5), 23.5 ( sd 16.6) and 23.5 ( sd 16.7), respectively; P = 0.099] or diabetes treatment satisfaction [29.0 ( sd 3.9), 28.2 ( sd 5.2) and 28.0 ( sd 7.1), respectively; P = 0.43]. Themes frequently mentioned in the interviews were 'positive effects at work', 'improved blood glucose', 'fewer worries about blood glucose', but also 'frequent alarms', 'technological issues' and 'demand for an all-in-one device'. Conclusions The psychological outcomes of artificial pancreas and sensor-augmented pump therapy were similar. Current artificial pancreas technology is promising but user concerns should be taken into account to ensure utility of these systems. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Background Research has established a negative association between household material hardship and children's mental health. This study examines whether Child Development Accounts (CDAs), an economic intervention that encourages families to accumulate assets for children's long-term development, mitigate the association between material hardship and children's social-emotional development. Methods Researchers conducted a randomized experiment of CDAs in Oklahoma, USA, with a probability sample ( N = 7328) of all infants born in two 3-month periods in 2007. After agreeing to participate in the experiment, caregivers of 2704 infants completed a baseline survey and were assigned randomly to the treatment ( n = 1358) or control group ( n = 1346). The intervention exposed the treatment group to a CDA, which consisted of an Oklahoma 529 College Savings Plan account, financial incentives and financial information. Results Material hardship has a negative association with the social-emotional development of children around the age of 4 years. Estimates from regression analysis indicate that CDAs mitigate about 50% of the negative association between material hardship and children's social-emotional development. Conclusions Although they do not provide direct support for consumption in households experiencing material hardship, CDAs may improve child development by influencing parenting practices and parents' expectations for their children. We discuss the implications of using asset-building programmes to improve child development. [ABSTRACT FROM AUTHOR]

Background Alcohol use disorder (AUD) is a highly prevalent public health problem associated with considerable individual and societal costs. Abstinence from alcohol is the most widely accepted target of treatment for AUD, but it severely limits treatment options and could deter individuals who prefer to reduce their drinking from seeking treatment. Clinical validation of reduced alcohol consumption as the primary outcome of alcohol clinical trials is critical for expanding treatment options. One potentially useful measure of alcohol treatment outcome is a reduction in the World Health Organization (WHO, International Guide for Monitoring Alcohol Consumption and Related Harm. Geneva, Switzerland, 2000) risk levels of alcohol use (very high risk, high risk, moderate risk, and low risk). For example, a 2-shift reduction in WHO risk levels (e.g., high risk to low risk) has been used by the European Medicines Agency (2010, Guideline on the Development of Medicinal Products for the Treatment of Alcohol Dependence. UK) to evaluate nalmefene as a treatment for alcohol dependence (AD; Mann et al. 2013, Biol Psychiatry 73, 706-13). Methods The current study was a secondary data analysis of the COMBINE study ( n = 1,383; Anton et al., ) to examine the association between reductions in WHO risk levels and reductions in alcohol-related consequences and mental health symptoms during and following treatment in patients with AD. Results Any reduction in WHO risk drinking level during treatment was associated with significantly fewer alcohol-related consequences and improved mental health at the end of treatment and for up to 1 year posttreatment. A greater reduction in WHO risk drinking level predicted a greater reduction in consequences and greater improvements in mental health. Conclusions Changes in WHO risk levels appear to be a valid end point for alcohol clinical trials. Based on the current findings, reductions in WHO risk drinking levels during treatment reflect meaningful reductions in alcohol-related consequences and improved functioning. [ABSTRACT FROM AUTHOR]

Aims To compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes. Design Randomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56). Setting Clinics in Minnesota, USA. Participants Smokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white. Measurements During the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers. Findings There were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition ( Ps < 0.05). Fewer combusted products were smoked at almost all visits ( Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97). Conclusion The offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates. [ABSTRACT FROM AUTHOR]

Strategies for preventing undernutrition comprise a range of interventions, including education, provision of complementary food and cash transfer. Here, we compared monthly distributions of two different lipid‐based nutrient supplements (LNS), large‐quantity LNS (LNS‐LQ) and medium‐quantity LNS (LNS‐MQ) for 15 months on prevention of undernutrition among children 6 to 23 months. Both groups also received cash transfer for the first 5 months of the intervention. We conducted a prospective intervention study in Maradi, Niger, between August 2011 and October 2012. Six and 11 villages were randomly allocated to LNS‐LQ/Cash and LNS‐MQ/Cash, respectively. Children measuring 60–80 cm were enrolled in the respective groups and followed up monthly. Poisson regression was used to assess differences between interventions and adjust for baseline characteristics, intervention periods and child‐feeding practices. The analysis included 2586 children (1081 in the LNS‐LQ/Cash group and 1505 in the LNS‐MQ/Cash group). This study suggests that provision of LNS‐LQ (reference) or LNS‐MQ had, overall, similar effect on incidence of severe acute malnutrition (RR = 0.97; 95% CI: 0.67–1.40; P = 0.88), moderate acute malnutrition (RR = 1.20; 95% CI: 0.97–1.48; P = 0.08), severe stunting (RR = 0.94; 95% CI: 0.70–1.26; P = 0.69), moderate stunting (RR = 0.95; 95% CI: 0.76–1.19; P = 0.67) and mortality (RR = 0.83; 95% CI: 0.41–1.65; P = 0.59). Compared with LNS‐LQ, LNS‐MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56–0.94; P = 0.01. These results highlight the need to design context‐specific programmes. Provision of LNS‐LQ might be more appropriate when food insecurity is high, while when food security is better, distribution of LNS‐MQ might be more appropriate. [ABSTRACT FROM AUTHOR]

Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource‐challenged settings. We designed a community‐based participatory nutrition promotion (CPNP) programme adapting a Positive Deviance/Hearth approach that engaged mothers in 2‐week nutrition sessions using the principles of ‘learning by doing’ around child feeding. We aimed to test the effectiveness of the CPNP for improving child growth in rural Ethiopia. A cluster randomized trial was implemented by adding the CPNP to the existing government nutrition programmes (six clusters) vs. government programmes only (six clusters). A total of 1790 children aged 6 to 12 months (876 in the intervention and 914 in the control areas) were enrolled and assessed on anthropometry every 3 months for a year. Multi‐level mixed‐effect regression analysis of longitudinal outcome data (n = 1475) examined the programme impact on growth, adjusting for clustering and enrollment characteristics. Compared with children 6 to 24 months of age in the control area, those in the intervention area had a greater increase in z scores for length‐for‐age [difference (diff): 0.021 z score/month, 95% CI: 0.008, 0.034] and weight‐for‐length (diff: 0.042 z score/month, 95% CI: 0.024, 0.059). At the end of the 12‐month follow‐up, children in the intervention area showed an 8.1% (P = 0.02) and 6.3% (P = 0.046) lower prevalence of stunting and underweight, respectively, after controlling for differences in the prevalence at enrollment, compared with the control group. A novel CPNP programme was effective in improving child growth and reducing undernutrition in this setting. © 2016 John Wiley & Sons Ltd [ABSTRACT FROM AUTHOR]

Aim To assess patient-reported outcome measures ( PROMs), aesthetics and stability of root coverage procedures from a previous 6-month RCT after 1 year. Material & Methods Forty-five patients (90 recessions) had received a coronally advanced flap ( CAF = control) only or a xenogeneic collagen matrix in addition ( CAF + CMX = test). Visual analogue scales ( VAS) and questionnaires were used for PROMs and the root coverage aesthetic score ( RES) for professional aesthetic evaluations. Results VAS scores (patient satisfaction) amounted to 8.58 ± 1.86 (test) versus 8.38 ± 2.46 (control). Six patients preferred CAF + CMX concerning surgical procedure and aesthetics, six preferred CAF and 29 were equally satisfied. RES was 7.85 ± 2.42 for the test group versus 7.34 ± 2.90 for the controls. Root coverage ( RC) was 76.28% for test and 75.05% for control defects. The mean increase in keratinized tissue width was higher in test (from 1.97 to 3.02 mm) than in controls (from 2.00 to 2.64 mm) ( p = 0.0413). Likewise, test sites showed more gain in gingival thickness (0.52 mm) than control sites (0.27 mm) ( p = 0.0023). Compared to 6 months, clinical outcomes were stable. Conclusions Results for PROMs, RES and RC did not significantly differ between treatment groups. Thickness and width of keratinized tissue were enhanced following CAF + CMX compared to CAF alone. [ABSTRACT FROM AUTHOR]

Objectives Mental ill-health has become a large health problem and it is important for caregivers to provide effective treatment alternatives. REGASSA is a randomized controlled study performed in primary care to study the effects of 12 weeks of Internet-based cognitive behaviour therapy ( ICBT) and physical exercise ( PE) compared with treatment as usual ( TAU) in patients with mild-to-moderate mental ill-health. The present study aimed to examine the results of these treatment alternatives on psychological functioning, stress, and sleep disturbances. Methods The study comprised 879 patients with mental ill-health taking part in the REGASSA study. Data were collected by Interactive Voice Response ( IVR), a computerized, automated telephone technique. The treatments were compared at baseline, twice during treatment, at the end of treatment and at three follow-ups after treatment. Measures used were the Outcome Questionnaire-45, the short versions of the Perceived Stress Scale, and the Karolinska Sleep Questionnaire. Results Linear mixed models showed that the patients in ICBT and PE had better results than in TAU on psychological functioning and sleep disturbances, p < .001 , with weak-to-moderate effect sizes. On stress there were no differences; all groups made improvements. Women had stronger effects than men. More patients recovered on psychological functioning ( OQ-45) in ICBT and PE than in TAU. Conclusions Internet-based cognitive behaviour therapy and PE proved to be effective treatment alternatives for patients with mild-to-moderate mental ill-health in improving psychological functioning, stress, and sleep disturbances and could be useful alternatives in primary care. Practitioner points Internet-based cognitive behaviour therapy and physical exercise proved to be effective treatment alternatives for mental ill-health patients in primary care., Automated techniques (Interactive Voice Response) could be useful for following treatment course in large groups of patients in the health care., It is important to use measures that capture different aspects of patients' health problems., The recruitment of participants was based on patients' interest and inclusion criteria which may have affect the generalizability. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND Bullying behavior in schools can lead to psychosocial problems. School-based interventions are important in raising student awareness, developing their skills and in planning to reduce bullying behavior. METHODS A randomized controlled trial, using a school-based educational intervention to reduce verbal bullying, was conducted among grade 10 students in 16 urban and rural schools in KwaZulu-Natal, South Africa in 2013. Baseline and postintervention questionnaires, developed using the Integrated Model for Behavior Change theoretical model, were used to assess changes in verbal bullying. RESULTS Postintervention there were reduced verbal bullying experiences. Improved social norms and awareness of verbal bullying were associated with reduced verbal bullying experiences and behavior. Although less likely to bully others verbally, girls were more likely to experience verbal bullying. Students with no living father were more likely to bully others verbally. CONCLUSIONS The study findings indicate that a school-based intervention can positively impact on verbal bullying experiences and behavior. [ABSTRACT FROM AUTHOR]

We tested both Rogers's hypothesis that listening enables speakers to experience psychological safety and our hypothesis that the benefit of listening for psychological safety is attenuated by avoidance-attachment style. We tested these hypotheses in six laboratory experiments, a field correlational study, and a scenario experiment. We meta-analyzed the results of the laboratory experiments and found that listening increased psychological safety on average but that the variance between the experiments was also significant. The between experiment variance in the effect of listening manipulation on psychological safety exposes a methodological challenge in choosing a research paradigm of good-versus-normal listening, as opposed to normal-versus-poor listening. More importantly, we found, as expected and across all designs, that the higher the avoidance-attachment style was, the lower the effect of listening on psychological safety. This finding has implications both for practice and for placing a theoretical boundary on Rogers's theory. [ABSTRACT FROM AUTHOR]

Background Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification ( CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Methods Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Results Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. Conclusions This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low-cost adjunctive treatment to improve treatment outcomes for alcohol-dependent patients. [ABSTRACT FROM AUTHOR]

Aims We tested two aims: (1) the teachable moment (TM): whether second-hand smoke exposure (SHSe) feedback motivates cessation in parents of children with asthma versus parents of healthy children (HC); and (2) whether greater intervention intensity [enhanced-precaution adoption model (PAM)] produces greater cessation than a previously tested intervention (PAM). Design and interventions Aim 1: two home visits (asthma education or child wellness), and cessation induction using motivational interviewing and SHSe feedback. Aim 2: post-home-visits, parents with asthmatic children were randomized to PAM (n = 171; six asthma education calls) or enhanced-PAM (n = 170; six asthma education/smoking cessation calls + repeat SHSe feedback). Setting Rhode Island, USA. Participants Parents of asthmatic (n = 341) or healthy (n = 219) children who did not have to want to quit smoking to enroll. Measurements Measurements were given at baseline, 2, 4, 6 and 12 months. Abstinence was bioverified. Outcomes were 7-day and 30-day point prevalence abstinence (ppa) and SHSe (primary) and asthma morbidity (secondary). Findings Aim 1: the TM was supported: parents of asthmatic children were more than twice as likely to achieve 30-day [odds ratio (OR) = 2.60, 95% confidence interval (CI) = 1.22-5.54] and 7-day ppa (OR = 2.26, 95% CI = 1.13-4.51) at 2 months (primary end-point) and have non-detectable levels of SHSe than HCs. Greater treatment intensity yielded stronger TM effects (OR = 3.60; 95% CI = 1.72-7.55). Aim 2: enhanced-PAM was more likely to achieve 30-day ppa at the primary end-point, 4 months (OR = 2.12, 95% CI 1.09-4.12) and improved asthma outcomes versus PAM. Conclusions Smoking cessation intervention (Motivational Interviewing plus biomarker feedback) appear to motivate smoking cessation more strongly among parents of asthmatic children than among parents of healthy children. Increased intervention intensity yields greater smoking cessation among parents of asthmatic children and better asthma outcomes. [ABSTRACT FROM AUTHOR]

HIV prevalence among Chinese men who have sex with men has rapidly increased in recent years. In this randomized, controlled study, we tested the feasibility and efficacy of motivational interviewing to reduce high-risk sexual behaviors among this population in Changsha, China. Eighty men who have sex with men were randomly assigned to either the intervention group, in which participants received a three-session motivational interviewing intervention over 4 weeks, or the control group, in which participants received usual counseling from peer educators. High-risk behavior indicators and HIV knowledge level were evaluated at baseline and 3 months after the intervention. Motivational interviewing significantly improved consistent anal condom use. However, there was no significant change in consistent condom use for oral sex or in the number of sexual partners over time. HIV knowledge scores improved equally in both groups. This study demonstrated that an intervention using motivational interviewing is feasible and results in increased condom use during anal sex for Chinese men who have sex with men. However, further work must be done to increase the use of condoms during oral sexual encounters. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective This study reports follow-up data from a multicenter randomized controlled trial ( n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. Methods Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. Results There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m2 for SSCM and 2.25 kg/m2 for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. Discussion Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800) [ABSTRACT FROM AUTHOR]

Background Heavy alcohol use during pregnancy can cause considerable developmental problems for children, but effects of light-moderate drinking are uncertain. This study examined possible effects of moderate drinking in pregnancy on children's conduct problems using a Mendelian randomisation design to improve causal inference. Methods A prospective cohort study ( ALSPAC) followed children from their mother's pregnancy to age 13 years. Analyses were based on 3,544 children whose mothers self-reported either not drinking alcohol during pregnancy or drinking up to six units per week without binge drinking. Children's conduct problem trajectories were classified as low risk, childhood-limited, adolescence-onset or early-onset-persistent, using six repeated measures of the Strengths and Difficulties Questionnaire between ages 4-13 years. Variants of alcohol-metabolising genes in children were used to create an instrumental variable for Mendelian randomisation analysis. Results Children's genotype scores were associated with early-onset-persistent conduct problems ( OR = 1.29, 95% CI = 1.04-1.60, p = .020) if mothers drank moderately in pregnancy, but not if mothers abstained from drinking ( OR = 0.94, CI = 0.72-1.25, p = .688). Children's genotype scores did not predict childhood-limited or adolescence-onset conduct problems. Conclusions This quasi-experimental study suggests that moderate alcohol drinking in pregnancy contributes to increased risk for children's early-onset-persistent conduct problems, but not childhood-limited or adolescence-onset conduct problems. [ABSTRACT FROM AUTHOR]

Background Reducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal. Methods Between June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U. S.-based sites. Daily smokers not currently interested in quitting ( n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content ( NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content ( VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers ( n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal. Results Over time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals). Conclusions The findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875). [ABSTRACT FROM AUTHOR]

Although cognitive interventions for obsessive-compulsive disorder (OCD) have been tested in randomized trials, there are few trials that have tested the specific mechanisms of cognitive interventions, i.e. how they achieve their effects. In this study, we aimed to investigate the mediating effects of a short cognitive intervention in the treatment of OCD and used data from a recently conducted randomized controlled trial where 101 participants were allocated to either Internet-based CBT (ICBT) or to a control condition. Obsessive beliefs were measured at pre-treatment, at the time they had received the cognitive intervention, and also at post-treatment. Weekly OCD symptoms were measured throughout the 10 weeks of treatment. We hypothesized that (1) the ICBT group would have greater reductions in obsessive beliefs (controlling for change in OCD symptoms) after completing the cognitive intervention, and that (2) this reduction would, in turn, predict greater OCD symptom reduction throughout the rest of the treatment period. Contrary to our expectations, the longitudinal mediation analysis indicated that (1) being randomized to ICBT actually increased the degree of obsessive beliefs after receiving the cognitive intervention at weeks 1-3, and (2) increase in obsessive beliefs predicted better outcome later in treatment. However, when repeating the analysis using cross-sectional data at post-treatment, the results were in line with the initial hypotheses. Results were replicated when the control condition received ICBT. We conclude that, although obsessive beliefs were significantly reduced at post-treatment for the ICBT group, early increase rather than decrease in obsessive beliefs predicted favourable outcome. [ABSTRACT FROM AUTHOR]