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

Background: The language of the science curriculum is complex, even in the early grades. To communicate their scientific observations, children must produce complex syntax, particularly complement clauses (e.g., I think it will float; We noticed that it vibrates). Complex syntax is often challenging for children with developmental language disorder (DLD), and thus their learning and communication of science may be compromised. Aims: We asked whether recast therapy delivered in the context of a science curriculum led to gains in complement clause use and scientific content knowledge. To understand the efficacy of recast therapy, we compared changes in science and language knowledge in children who received treatment for complement clauses embedded in a first‐grade science curriculum to two active control conditions (vocabulary + science, phonological awareness + science). Methods & Procedures: This 2‐year single‐site three‐arm parallel randomized controlled trial was conducted in Delaware, USA. Children with DLD, not yet in first grade and with low accuracy on complement clauses, were eligible. Thirty‐three 4–7‐year‐old children participated in the summers of 2018 and 2019 (2020 was cancelled due to COVID‐19). We assigned participants to arms using 1:1:1 pseudo‐random allocation (avoiding placing siblings together). The intervention consisted of 39 small‐group sessions of recast therapy, robust vocabulary instruction or phonological awareness intervention during eight science units over 4 weeks, followed by two science units (1 week) taught without language intervention. Pre‐/post‐measures were collected 3 weeks before and after camp by unmasked assessors. Outcomes & Results: Primary outcome measures were accuracy on a 20‐item probe of complement clause production and performance on ten 10‐item unit tests (eight science + language, two science only). Complete data were available for 31 children (10 grammar, 21 active control); two others were lost to follow‐up. Both groups made similar gains on science unit tests for science + language content (pre versus post, d = 2.9, p < 0.0001; group, p = 0.24). The grammar group performed significantly better at post‐test than the active control group (d = 2.5, p = 0.049) on complement clause probes and marginally better on science‐only unit tests (d = 2.5, p = 0.051). Conclusions & Implications: Children with DLD can benefit from language intervention embedded in curricular content and learn both language and science targets taught simultaneously. Tentative findings suggest that treatment for grammar targets may improve academic outcomes. What this paper adds: What is already known on the subject: We know that recast therapy focused on morphology is effective but very time consuming. Treatment for complex syntax in young children has preliminary efficacy data available. Prior research provides mixed evidence as to children's ability to learn language targets in conjunction with other information. What this study adds: This study provides additional data supporting the efficacy of intensive complex syntax recast therapy for children ages 4–7 with Developmental Language Disorder. It also provides data that children can learn language targets and science curricular content simultaneously. What are the clinical implications of this work?: As SLPs, we have to talk about something to deliver language therapy; we should consider talking about curricular content. Recast therapy focused on syntactic frames is effective with young children. [ABSTRACT FROM AUTHOR]

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]

Many studies have demonstrated the crucial role of vocabulary in predicting reading performance in general. More recent work has indicated that one particular facet of vocabulary (its depth) is more closely related to language comprehension, especially inferential comprehension. On this basis, we developed a training application to specifically improve vocabulary depth. The objective of this study was to test the effectiveness of a mobile application designed to improve vocabulary depth. The effectiveness of this training was examined on 3rd and 4th grade children's vocabulary (breadth and depth), decoding and comprehension performances. A randomized waiting‐list control paradigm was used in which an experimental group first received the intervention during the first 4 weeks (between pretest and post‐test1), thereafter, a waiting control group received the training for the next 4 weeks (between postest1 and posttest2). Results showed that the developed application led to significant improvements in terms of vocabulary depth performance, as well as a significant transfer effect to reading comprehension. However, we did not observe such a beneficial effect on either vocabulary breadth or written word identification. These results are discussed in terms of the links between vocabulary depth and comprehension, and the opportunities the app presents for remedying language comprehension deficits in children. Lay Description: What is already known about this topic:Vocabulary is a powerful predictor of both word identification and text comprehensionVocabulary depth rather than breadth is more closely related to language comprehensionDepth of vocabulary is particularly predictive of inferencing skills What this paper adds:We develop a new training application specifically targeting vocabulary depthThe training led to significant gain in children's knowledge for the taught wordsWe also observe a transfer effect with significant improvements in reading comprehension Implications for practice and/or policy:Vocabulary depth trainings represent a good way for remedying language comprehension deficits [ABSTRACT FROM AUTHOR]

We used a randomized controlled trial to investigate if a mobile game, GraphoLearn (GL), could effectively support the learning of first graders (N = 70), who have severe difficulties in reading and spelling. We studied the effects of two versions of the game: GL Reading, which focused on training letter‐sound correspondence and word reading; and GL Spelling, which included additional training in phonological skills and spelling. During the spring of first grade, the children trained with tablet computers which they could carry with them during the six‐week intervention. The average exposure time to training was 5 hr 44 min. The results revealed no differences in the development of reading or spelling skills between GL players and the control group. However, pre‐training self‐efficacy moderated the effect among GL Reading players: children with high self‐efficacy developed more than the control group in word reading fluency, whereas children with low self‐efficacy developed less than the control group in spelling. Lay Description: What is already known: Serious games can support children's reading achievement, but less is known about their effects in mobile learning.GraphoLearn (GL) is a serious game designed to support reading acquisition, but previous studies suggest its effect on word‐level reading is limited.Explicit training of phonological skills and spelling could facilitate transfer to word reading.Self‐efficacy predicts persistence and effort in achievement situations but its role in mobile game‐based learning is not well known. What this paper adds: A randomized controlled trial was used to study if mobile game‐based learning supports children with reading difficulties.A new GL version, training phonological and spelling skills, had no effect on the development of reading and spelling skills.Children with high self‐efficacy benefited from training with the standard GL. Implications for practitioners: When using mobile games as support tools, close attention should be paid to learner characteristics and game design.Children with high self‐efficacy may be better able to regulate their behaviour during independent training with mobile games, leading to better learning outcomes. [ABSTRACT FROM AUTHOR]

Sound‐augmented toys producing factual knowledge were thought to encourage incidental, playful learning in children with visual impairments (VIs). A group of 15 children with VIs and 22 sighted controls played with a sound‐augmented savannah landscape and listened to an informative story in a counterbalanced order. Children's knowledge about savannah animals was assessed at baseline and after each condition in order to quantitatively compare knowledge gains between conditions. Results indicated that children with VIs gained more knowledge than sighted controls from playing with the sound‐augmented toy. Furthermore, offering both the augmented toy and the informative story led to higher knowledge gains than a single medium, especially in children with VIs. Sound‐augmented toys could therefore be a useful addition to the current curriculum in special education for children with VIs. Lay Description: What is already known about this topic: Game‐based learning is becoming more popular as educational context.Children with visual impairments are often unable to benefit from a predominantly visual learning context.Augmented environments encourage exploratory learning by enhancing physical materials with technology.Sound‐augmented toys might encourage playful learning in children with visual impairments. What this paper adds: This empirical study compared an innovative sound‐augmented toy with traditional verbal instruction.Both children with visual impairments and a sighted comparison group participated.The targeted learning outcome was factual knowledge about animals.Children gained comparable knowledge from the augmented environment as from verbal instruction.The augmented toy was a more effective learning context for children with visual impairments than in sighted children. Implications for practice and/or policy: Sound‐augmented environments encourage object interaction and playful learning in children with visual impairments.Sound‐augmented toys can be a useful addition to the current curriculum of children with visual impairments in special education. [ABSTRACT FROM AUTHOR]

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Background: Children's pain in dentistry has undesirable short‐ and long‐term consequences; therefore, less invasive treatments merit consideration. Aim: To investigate procedural pain scores for two treatments for carious primary molars in New Zealand primary care. Design: This study was a split‐mouth randomised control trial, with secondary outcome analysis. Children (4–8 years) with proximal carious lesions on matched primary molars had one tooth treated with the Hall technique (HT) and one treated with a conventional stainless steel crown (CT); treatment type and order of treatment were randomly allocated (allocation concealment). The Wong–Baker self‐report pain scale measured pretreatment dental pain, procedural pain at each treatment and post‐operative pain. Results: Data were analysed for 103 children: 49 children had the HT first and 54 children had the CT first. Procedural pain scores did not differ by treatment type, with 71.8% and 76.7% of children reporting low pain for the HT and the CT, respectively. Fewer children reported low procedural pain for the second treatment than the first (p =.047). Most children reported low procedural pain for both treatments (58.3%), although 41.7% experienced moderate–high procedural pain with at least one treatment. Conclusions: The HT caused pain for as many children as the CT. There is an opportunity for better dental pain management in this setting. [ABSTRACT FROM AUTHOR]

Background: Needle‐free injection systems can contribute to the prevention of needle‐related pain during palatal infiltration anesthesia (PIA) in children. Research on this topic in children is required. Aim: The purpose of this clinical study was to evaluate the effectiveness and patient preference of a needle‐free system versus traditional anesthesia (TA) on pain perception during PIA in children. Design: The study was designed as a randomized, controlled crossover clinical study with 48 children aged 6–12 years requiring dental treatment with PIA in bilateral maxillary primary molars. TA was applied on one side and the Comfort‐in™ injection system (CIS) on the other side in two separate sessions. Then, patient preference was recorded. The pain perception during PIA was evaluated using the Wong–Baker FACES Pain Rating Scale (PRS) and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The data were analyzed for statistical significance (p <.05). Results: There were statistically significant differences between the TA and the CIS according to the PRS and FLACC Scale scores. On both scales, significantly higher pain ratings were observed in the TA group during PIA (p <.001). There was a statistically significant difference in terms of patient preference (p <.001). Although 77.1% (n = 37) of the children preferred the CIS, 22.9% (n = 11) preferred the TA. Moreover, patient preference for the CIS was significantly higher in older children (p <.01). Conclusions: The application of a needle‐free system during PIA ensured a decrease in pain perception in children. [ABSTRACT FROM AUTHOR]

Micronutrient supplementation is widely used to prevent stunting in children under 5 years in low‐ and middle‐income countries (LMIC), but the impact of treatment has been disappointing, possibly due to non‐compliance. Our aim was to deliver long‐term micronutrient supplementation via a novel, culturally acceptable liquid food to improve linear growth in a high stunting prevalence region. In a randomised control trial, 971 children aged 6–72 months received either 'Chispuditos®' (n = 681), a hot drink (atole) fortified with micronutrients (atole + MN) (9 mg/zinc, 12.5 mg/iron), or lactose‐free milk (n = 290) for 18 months. Primary outcomes were changes in length/height‐for‐age (HAZ) score and the prevalence of stunting at 18‐month follow‐up. Adherence was monitored monthly, and 73% children in atole + MN group consumed at least half their daily zinc and iron requirement. At 18 months, there was no difference between the treatments in growth [mean change in HAZ −0.02 (95% CI −0.12, 0.08)] or stunting [atole + MN 41%, milk 41%; RR 0.99 (95% CI 0.84, 1.19)]. There were no differences in haemoglobin (HB), ferritin or zinc. No children had iron deficiency anaemia (IDA) at outcome, but zinc deficiency remained equally prevalent in both groups: atole + MN 35%, milk 35% [RR 1.02 (95% CI 0.83, 1.24)]. There was no difference in morbidity between the groups, and micronutrient status was unrelated to HAZ. Long‐term micronutrient supplementation via a culturally acceptable food had no impact on stunting or morbidity, raising the question of whether large‐scale micronutrient supplementation is worthwhile. [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]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

Purpose: Child participation in type 1 diabetes (T1D) self‐care is needed in developing countries due to a lack of resources, especially during the school day. This pilot study evaluated the feasibility of a therapeutic play intervention (ITP) versus standard education (SE) on the ability of children with T1D to correctly perform insulin injection technique. Design and Methods: Children with T1D (7–12 years) were recruited at two diabetes clinics in Brazil and randomized to ITP or SE. Registered nurses received protocol training to deliver the intervention and perform data collection. ITP group received an education that included a story about a child with T1D who self‐injects insulin at school; SE group received routine clinic‐based education. Preintervention, children were video‐recorded giving insulin injections to a doll; postintervention, children were rerecorded giving the doll an injection. The research team reviewed the videos and assessed the injection technique using validated checklists. Parents reported children's self‐injection practices at baseline and 30 days. Results: Children (N = 20, 40% male) were 9.6 ± 1.3 years old and had T1D for 3.6 ± 2.3 years; HbA1c was 9.1 ± 2.0%; 20% of ITP and 50% of SE children used syringes (vs. pens) for injections. At baseline, 80% of both groups knew how to self‐inject; most were taught by a parent/relative. Injection technique scores were low in both groups; ITP group increased their scores significantly postintervention. Practices of self‐injection did not change in either group after 30 days. Practice Implications: The play‐based intervention appeared to improve the injection technique in the short‐term. Pilot findings support the development of a larger trial to evaluate the effectiveness of ITP on educating children on insulin injections. [ABSTRACT FROM AUTHOR]

Multiple micronutrient deficiencies (MNDs) co‐exist, often because of poor intakes and adversely impact health. Habitual diets were assessed in 300 school children (6–17 years old) recruited from two government schools by simple random sampling. Probability of adequacy (PA) for 11 micronutrients and mean probability of adequacy (MPA) was calculated. Haemoglobin, plasma ferritin, folic acid, vitamin B12 and C‐reactive protein were estimated. Descriptive statistics and regression analysis were used to estimate magnitude and factors associated with MNDs. The contribution of fortified foods and/or supplements in addressing inadequacies and excessive intakes was modelled. The PA ranged from 0.04 for folate to 0.70 for zinc, and the MPA was 0.27. Prevalence of anaemia (53%), iron deficiency (57%; ID), iron deficiency anaemia (38%; IDA), folate deficiency (24%) and B12 deficiency (43%) was high. Dietary inadequacy of iron, zinc and a low MPA was associated with anaemia and IDA. Inclusion of double fortified salt (DFS), fortified rice (FR) or iron folic acid (IFA) supplements individually in habitual diet reduced probability of iron inadequacy significantly from 82% to ≤13%. Inclusion of DFS and FR simultaneously led to disappearance of iron inadequacy, but risk of excessive intake increased to 16%. Inclusion of DFS, FR and IFA together increased risk of excess iron intake to 40%. Nevertheless, intakes of folate and B12 remained inadequate even with FR and/or IFA. These results indicate a high risk of dietary MNDs in children and suggest need for more systematic intake measurements in representative sample and adjustment of iron dosages to avoid excessive intakes. [ABSTRACT FROM AUTHOR]

There are no guidelines for the optimal protein quality of ready‐to‐supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double‐blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein‐optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6–59 months of age treated with 75 kcal/kg/day of either control or protein quality‐optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein‐optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, −2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness. [ABSTRACT FROM AUTHOR]

Adding amylase to fortified blended foods can improve energy density, and increase child's energy and nutrient intake. The efficacy of this strategy is unknown for the World Food Programme's Super Cereal Plus (SC+) and Super Cereal (SC) blends. The primary goal of this study was to investigate the increased energy intake from amylase-containing SC+ and SC compared to control porridges in Burkinabe children. Secondly, energy intake from amylase-containing porridges compared to CERELAC®, Vitazom, and eeZeeBAR™ was studied. Thirdly, caregivers' ( n = 100) porridge acceptability was investigated. The design was a randomized double-blind controlled cross-over trial studying the effect of amylase addition to SC+ and SC flours on porridge energy and nutrient intake in healthy Burkinabe children aged 12-23 ( n = 80) and 24-35 months ( n = 40). Amylase added to porridges increased energy density from 0.68 to 1.16 kcal/g for SC+ and from 0.66 to 1.03 kcal/g for SC porridges. Among children aged 12-23 months, mean energy intake from all porridges with amylase (135-164 kcal/meal) was significantly higher compared to control SC+ porridges (84-98 kcal/meal; model-based average). Among children aged 24-35 months, mean energy intakes were also significantly higher from all porridges with amylase added (245-288 kcal/meal) compared to control SC porridges (175-183 kcal/meal). Acceptability of the porridges among caregivers was rated neutral to good, both for amylase-added and non-amylase-containing porridges. These findings suggest that, among 12-35-month-old, adding amylase to fortified blended foods significantly increased energy and consequently nutrient intake per meal by 67% for SC+ and 47% for SC. Moreover, amylase-containing porridges were well accepted by the caregivers. [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]

Aim A split-mouth randomized clinical trial was carried out to assess the effectiveness of a school-based dental sealant ( SBDS) program for French children from low-income backgrounds within 3 years of follow-up. The secondary objectives were to determine the risk factors for the occurrence of new carious lesions ( ICDAS 3-6) on first permanent molars, to evaluate the effectiveness of the program according to risk factors and to assess sealant retention. Methods The study included 276 6- to 7-year old pupils (457 pairs of first permanent molars) from Nice. The sealing was performed in first- or second-grade children. The first permanent molars were randomized into two groups: One received resin-based sealant and the other formed a nontreatment group. Carious lesions ICDAS 3-6 on permanent and primary teeth, visible plaque, streptococcus mutans and/or lactobacillus counts were recorded at baseline to assess individual caries risk ( ICR). The putative confounders recorded at baseline were sex, grade level, and characteristics of first permanent molars. An intent-to-treat analysis was performed, where the study outcome was the occurrence of new carious lesions within 3 years of follow-up. Univariate and multivariate Cox proportional hazards models (hazard risk, HR) using the procedure PHREG with the option of Covsandwich were performed in SAS to assess the effectiveness of the SBDS program. Results At 3 years of follow-up, 228 children (378 tooth pairs) remained in the analysis. The survival analysis showed that first permanent molars that received sealants had 67% (adjusted HR: 0.33; 95% CI: 0.24-0.46) less risk of developing new carious lesions during all the follow-up than molars without sealant. In addition, children with carious lesions ICDAS 3-6 on permanent and primary teeth, that is, high ICR, had three times the risk of having a new carious lesion than others without, independently of the sealant treatment (adjusted HR: 3.00; 95% CI: 1.55-5.75). Effectiveness of the SBDS program at 3 years of follow-up depended on the presence of carious lesions ICDAS 3-6 ( HR in 173 children with carious lesions: 0.32; 95% CI: 0.23-0.46) at baseline ( HR in 103 children without carious lesions: 0.42; 95% CI: 0.16-1.12). Finally, the overall retention rate was 32.3%. Conclusion The effectiveness of the SBDS program was demonstrated in low socioeconomic areas. Selection of schoolchildren according to the presence of carious lesions ICDAS 3-6 should be considered in a SBDS program. [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]

Background Failed restorations in primary teeth are not always re-restored. Is re-restoration not required anymore? Objective To compare survival rates of primary molars with intact and defective amalgam and ART restorations. Methods A total of 649 restored primary molars, of which 162 were assessed with defective restorations for mechanical reasons, from a cluster-randomised controlled clinical trial, were followed up over a period of 3.5 years. Restored primary molars, extracted because of dental sepsis or toothache, were considered a failure. Primary molars with defective restorations were followed up from the time they were assessed defective. Data were analysed using PHREG model with frailty correction, Wald test, t-test, and jackknife procedure. Results The survival rate of primary molars with intact restorations (96.3%) was statistically significantly higher than that of primary molars with defective restorations (75.9%) over a 3-year period ( P < 0.0001). Neither the effect of treatment protocol (amalgam or ART) ( P = 0.05) nor the type of surface (single or multiple) ( P = 0.73) was observed with respect to the survival rate of restored primary molars. Conclusions Survival rates for primary molars with intact and defective amalgam and ART restorations were high. The 3-year survival rate of primary molars with intact restorations was significantly higher than that of primary molars with defective restorations. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND We examined the effects of short bouts of structured physical activity (SBS-PA) implemented within the classroom setting as part of designated gross-motor playtime on preschoolers PA. METHODS Preschools were randomized to SBS-PA (centers, N = 5; participants, N = 141) or unstructured free playtime (UPA) (centers, N = 5; participants, N = 150). SBS-PA consisted of structured PA implemented in the classroom during the first 10 minutes of gross-motor playtime followed by 20 minutes of free playtime. UPA consisted of 30 minutes of unstructured free playtime. Teachers implemented both conditions for 5 days/week for 6 months. PA was assessed with accelerometers (preschool-day) and direct observation (30-minute sessions). Generalized linear mixed models were used to examine the impact of the intervention. RESULTS Regarding the 30-minute sessions, significant group main effects were observed for intervals spent at light (p < .001) and moderate-to-vigorous PA (MVPA, p < .001). Regarding the preschool-day PA, significant group by visit interaction was observed for percent time spent in total preschool-day MVPA (F (2, 254) = 3.54, p = .03). Percent of time spent in MVPA significantly decreased in both groups at 3 months and at 6 months. CONCLUSION SBS-PA can be implemented in classroom settings; however, further research is needed to examine its impact on preschoolers PA levels. [ABSTRACT FROM AUTHOR]

Background Extended-release guanfacine hydrochloride ( GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder ( ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6-17 years) with ADHD received open-label GXR (1-7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase ( RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure ( TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; Eudra CT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group ( p = 0.006). TTF was significantly longer in GXR versus placebo ( p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. [ABSTRACT FROM AUTHOR]

Asthma morbidity and mortality is higher among older school‐age children and early adolescents than other age groups across the lifespan. NIH recommended expanding asthma education to schools and community settings to meet cognitive outcomes that have an impact on morbidity and mortality. Guided by the acceptance of asthma model, an evidence‐guided, comprehensive school‐based academic health education and counseling program, Staying Healthy—Asthma Responsible & Prepared™ (SHARP), was developed. The program complements existing school curricula by integrating biology, psychology, and sociology content with related spelling, math, and reading and writing assignments. Feasibility, benefits, and efficacy have been established. We compared the effectiveness of SHARP to a non‐academic program, Open Airways for Schools, in improving asthma knowledge and reasoning about symptom management. A two‐group, cluster‐randomized, single‐blinded design was used with a sample of 205 students in grades 4–5 with asthma and their caregivers. Schools were matched prior to randomization. The unit of analysis was the student. Certified elementary school teachers delivered the programs during instructional time. Data were collected from student/caregiver dyads at baseline and at 1, 12, and 24 months after the intervention. In multilevel modeling, students enrolled in the academic SHARP program demonstrated significant (p< .001) improvement in asthma knowledge and reasoning over students enrolled in the non‐academic program. Knowledge advantages were retained at 24 months. Findings support delivery in schools of the SHARP academic health education program for students with asthma. © 2015 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Low nutritional value of complementary foods is associated with high incidence of childhood growth stunting in low‐income countries. This study was done to test a hypothesis that dietary complementation with lipid‐based nutrient supplements (LNS) promotes linear growth and reduces the incidence of severe stunting among at‐risk infants. A total of 840 6‐month‐old healthy infants in rural Malawi were enrolled to a randomised assessor‐blinded trial. The participants received 12‐month supplementation with nothing, milk–LNS, soy–LNS, or corn–soy blend (CSB). Supplements provided micronutrients and approximately 280 kcal energy per day. Outcomes were incidence of severe and very severe stunting [length‐for‐age z‐score, (LAZ) < −3.00 and <−3.50, respectively], and change in LAZ. The incidence of severe stunting was 11.8%, 8.2%, 9.1% and 15.5% (P = 0.098) and that of very severe stunting 7.4%, 2.9%, 8.0% and 6.4% (P = 0.138) in control, milk–LNS, soy–LNS and CSB groups, respectively. Between 9 and 12 months of age, the mean change in LAZ was −0.15, −0.02, −0.12 and −0.18 (P = 0.045) for control, milk–LNS, soy–LNS and CSB groups, respectively. There was no significant between‐group difference in linear growth during other age‐intervals. Although participants who received milk–LNS had the lowest incidence of severe and very severe stunting, the differences between the groups were smaller than expected. Thus, the results do not provide conclusive evidence on a causal association between the LNS supplementation and the lower incidence of stunting. Exploratory analyses suggest that provision of milk–LNS, but not soy–LNS promotes linear growth among at‐risk infants mainly between 9 and 12 months of age. [ABSTRACT FROM AUTHOR]

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy‐dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn–soy blend (CSB) or lipid‐based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8–18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24‐h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37–250; P < 0.001) and 46 (1.5–7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non‐supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non‐supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings. [ABSTRACT FROM AUTHOR]

Anaemia affects 46% of preschool‐aged children in Nepal. A cluster‐randomised study was conducted in rural Nepal to test whether providing micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education, could lead to a higher reduction in anaemia compared with providing only EHFP. This sub‐study enrolled 335 children aged 6–9 months into one of three groups: (1) EHFP + MNP; (2) EHFP; or (3) control. The EHFP + MNP group received 60 sachets of MNP for flexible consumption at the start and 6 months later for a total supplementation period of 11 months. The MNP contained 15 micronutrients including iron (10 mg encapsulated ferrous fumarate). Haemoglobin and anthropometry were measured at baseline and post‐MNP supplementation. Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non‐significant increase in the EHFP + MNP and EHFP compared with control (difference‐in‐differences: 4.1 g L−1 for EHFP + MNP vs. control; 3.6 g L−1 for EHFP vs. control; 0.5 g L−1 for EHFP + MNP vs. EHFP). Anaemia decreased at a slightly higher magnitude in the EHFP + MNP [51.5 percentage points (PP)] than the EHFP (48.6 PP) and control (39.6 PP), with adjusted odds ratios (95% CI) at post‐supplementation of 0.52 (0.25–1.12) for EHFP + MNP and 0.69 (0.35–1.36) for EHFP, compared with control. There was no impact on child growth. Combining EHFP and MNP programmes yielded a marginally significant reduction in anaemia among children. [ABSTRACT FROM AUTHOR]

Background Longer and more complex dental procedures could negatively affect patient's acceptability of minimal invasive techniques. Aims and Methods Therefore, this short communication aims to show the preliminary findings regarding children's discomfort reported after some minimal invasive treatments in treating initial caries lesions on approximal surfaces: flossing instruction, silver diamine fluoride ( SDF) application and caries resin infiltration. Results Children allocated in the infiltration group showed higher levels of discomfort than those in the SDF and control groups. Conclusions These findings suggest that the simplest interventions for approximal initial caries lesions cause less discomfort for children and should be applied where possible. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the impact of dental caries treatment on oral health-related quality of life (OHRQoL) among schoolchildren and the responsiveness of the Child Perceptions Questionnaire (CPQ8-10) instrument. Brazilian schoolchildren, 8-10 yr of age, were randomly selected and assigned to two groups - dental caries treatment (DCT) and caries-free (CF) - according to their caries experience [decayed, missing, or filled primary teeth (dmft) and decayed, missing or filled secondary teeth (DMFT) values of ≥0]. The CPQ8-10 instrument was administered at baseline and at 4 wk of follow-up (i.e. 4 wk after completion of dental treatment). In the DCT group, increases in CPQ8-10 scores were observed between the baseline and follow-up results. However, longitudinal evaluation of the CF group demonstrated no statistically significant difference in CPQ8-10 scores. Responsiveness of the CPQ8-10 instrument (magnitude of change in CPQ8-10 scores) in the DCT group was greater (effect size >0.7) than in the CF group. The findings of this study show that dental caries treatment has an important impact on OHRQoL of children. The CPQ8-10 was considered an acceptable instrument for longitudinal measurement of changes in OHRQoL. [ABSTRACT FROM AUTHOR]

Background. Dental biofilm removal is difficult and can be ineffective in individuals with cerebral palsy. Objective. Determine the effectiveness of brushing with an electric toothbrush on and off in comparison with manual brushing for the removal of biofilm in children aged four to 16 years with cerebral palsy. Methods. A crossover, randomized, simple-blind, clinical trial was conducted. The examiner was blinded to the brushing method (G1: manual; G2: electric toothbrush on; and G3: electric toothbrush off). The order was determined randomly. The participants (n = 40) were examined before and after brushing performed by caregivers using the Turesky-Quigley-Hein biofilm index. Statistical analysis involved the paired t-test, Wilcoxon, Kruskal-Wallis, and ANOVA tests. Results. Biofilm was significantly reduced with the three brushing methods (P < 0.001) (mean reductions: 47.6% in G1; 47.4% in G2; 44.5% in G3). Significant differences were found between G1 and G3 (P < 0.001) and between G2 and G3 (P = 0.007). No significant difference was found between G1 and G2 (P = 0.06). Conclusion. All methods reduced biofilm. Effectiveness was similar between manual brushing and with the electric toothbrush on, whereas both these methods achieved better results in comparison with the electric toothbrush switched off. [ABSTRACT FROM AUTHOR]

Optimal infant and young child feeding (IYCF) practices can help ensure nutrient adequacy and support healthy growth and development. Small-quantity lipid-based nutrient supplements (SQ-LNS) have been proposed to help fill nutrient gaps, but little is known about the impact of provision of SQ-LNS on breastfeeding or complementary feeding practices. In the context of four coordinated randomized controlled nutrient supplementation trials in diverse sites in Africa, we compared IYCF practices at infant age 18 months (after 9-12 months of supplementation) between those receiving and not receiving SQ-LNS. Practices were assessed by caregiver recall. Continued breastfeeding ranged from 74% (Ghana site) to 97% (Burkina Faso site) and did not differ between groups in any site; prevalence of frequent breastfeeding also did not differ. In two sites (Burkina Faso and Malawi), infants receiving SQ-LNS were more likely to meet the World Health Organization recommendations for frequency of feeding (percentage point differences of 12-14%, P < 0.0001 and P = 0.005, respectively; the remaining two sites did not have data for this indicator). Most indicators of infant dietary diversity did not differ between groups in any site, but in the same two sites where frequency of feeding differed, infants receiving SQ-LNS were less likely to have low frequency of consumption of animal-source foods in the previous week (percentage point differences of 9-19% for lowest tertile, P = .02 and P = 0.04, respectively). We conclude that provision of SQ-LNS did not negatively impact self-reported IYCF practices and may have positively impacted frequency of feeding. [ABSTRACT FROM AUTHOR]