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Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial.

ABSTRACT: The transition to primary school appears crucial for a child's future academic and psychological well-being. Addressing conditions which negatively affect children during this period, such as poor sleep, may improve these outcomes. Sleep problems are common and in a previous efficacy randomised controlled trial, we demonstrated that sleep problems can be identified and improved using school-based screening followed by a brief behavioural intervention. This trial will determine whether the same intervention is beneficial and cost-effective when delivered by an existing school-based health workforce.We will recruit 334 children with sleep problems from approximately 40 schools after screening for behavioural sleep problems in the first year of formal education (Grade Prep). Schools in Melbourne, Australia will be invited to participate from a randomly ordered list of eligible schools and we will approach all caregivers of Grade Prep children. Children who have a parent-reported moderate or severe sleep problem will be randomised into either 'usual care' or 'intervention' groups. Trained nurses from the Primary School Nursing programme will deliver the sleep intervention programme.Two to three contacts between the nurse and the parent; initial 45 min face-to-face meeting or phone call, 15 min phone call 2 weeks later and an optional second 30 min face-to-face meeting.6 and 12 months postrandomisation using parent and teacher surveys and child face-to-face assessments.child psychosocial functioning at 6 months.child psychosocial functioning at 12 months and child sleep, behaviour, working memory, academic achievement and parent mental health at 6 and 12 months. Cost-effectiveness analysis will compare incremental costs to difference in child psychosocial functioning at 6 months.International Standard Randomised Controlled Trial Number Register (ISRCTN92448857).

SUBMITTER: Quach J

PROVIDER: S-EPMC3816243 | biostudies-other | 2013

REPOSITORIES: biostudies-other

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Project description:BackgroundApproximately one-third of the healthy population suffer from sleep problems, but only a small proportion of those affected receive professional help. Therefore, there is an urgent need for easily accessible, affordable, and efficacious sleep interventions.ObjectiveA randomized controlled study was conducted to investigate the efficacy of a low-threshold sleep intervention consisting of either (i) sleep data feedback plus sleep education or (ii) sleep data feedback alone in comparison with (iii) no intervention.Material and methodsA total of 100 employees of the University of Salzburg (age: 39.51 ± 11.43 years, range: 22-62 years) were randomly assigned to one of the three groups. During the 2-week study period, objective sleep parameters were assessed via actigraphy. In addition, an online questionnaire and a daily digital diary were used to record subjective sleep parameters, work-related factors, as well as mood and well-being. After 1 week, a personal appointment was conducted with participants of both experimental group 1 (EG1) and experimental group 2 (EG2). While the EG2 only received feedback about their sleep data from week 1, the EG1 additionally received a 45-min sleep education intervention containing sleep hygiene rules and recommendations regarding stimulus control. A waiting-list control group (CG) did not receive any feedback until the end of the study.ResultsResults indicate positive effects on sleep and well-being following sleep monitoring over the course of 2 weeks and minimal intervention with a single in-person appointment including sleep data feedback. Improvements are seen in sleep quality, mood, vitality, and actigraphy-measured sleep efficiency (SE; EG1), as well as in well-being and sleep onset latency (SOL) in EG2. The inactive CG did not improve in any parameter.ConclusionResults suggest small and beneficial effects on sleep and well-being in people being continuously monitored and receiving (actigraphy-based) sleep feedback when paired with a single-time personal intervention.

Project description:INTRODUCTION:The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes. METHODS AND ANALYSIS:This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted. ETHICS AND DISSEMINATION:Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families. PRE-RESULTS TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).

Project description:BackgroundThe Nutrition Embedded Evaluation Programme Impact Evaluation (NEEP-IE) study is a cluster randomised controlled trial designed to evaluate the impact of a childcare centre-based integrated nutritional and agricultural intervention on the diets, nutrition and development of young children in Malawi. The intervention includes activities to improve nutritious food production and training/behaviour-change communication to improve food intake, care and hygiene practices. This paper presents the rationale and study design for this randomised control trial.MethodsSixty community-based childcare centres (CBCCs) in rural communities around Zomba district, Malawi, were randomised to either (1) a control group where children were attending CBCCs supported by Save the Children's Early Childhood Health and Development (ECD) programme, or (2) an intervention group where nutritional and agricultural support activities were provided alongside the routine provision of the Save the Children's ECD programme. Primary outcomes at child level include dietary intake (measured through 24-h recall), whilst secondary outcomes include child development (Malawi Development Assessment Tool (MDAT)) and nutritional status (anthropometric measurements). At household level, primary outcomes include smallholder farmer production output and crop-mix (recall of last production season). Intermediate outcomes along theorised agricultural and nutritional pathways were measured. During this trial, we will follow a mixed-methods approach and undertake child-, household-, CBCC- and market-level surveys and assessments as well as in-depth interviews and focus group discussions with project stakeholders.DiscussionAssessing the simultaneous impact of preschool meals on diets, nutrition, child development and agriculture is a complex undertaking. This study is the first to explicitly examine, from a food systems perspective, the impact of a preschool meals programme on dietary choices, alongside outcomes in the nutritional, child development and agricultural domains. The findings of this evaluation will provide evidence to support policymakers in the scale-up of national programmes.Trial registrationISRCTN registry, ID: ISRCTN96497560 . Registered on 21 September 2016.

Project description:BACKGROUND:Child maltreatment has a pervasive, detrimental impact on children's wellbeing. Despite a growing focus on prevention through school based education, few programmes adopt a whole- school approach, are multi-component, seek to address all forms of maltreatment, or indeed have been robustly evaluated. This paper describes a cluster randomised controlled trial designed to evaluate a school based child maltreatment prevention programme: 'Keeping Safe' in primary schools in Northern Ireland. The intervention has been designed by a non-profit agency. Programme resources include 63 lessons taught incrementally to children between four and 11 years old, and is premised on three core themes: healthy relationships, my body, and being safe. There are programme resources to engage parents and to build the capacity and skills of school staff. METHODS/DESIGN:A cluster Randomised Controlled Trial (RCT) will be conducted with children in 80 schools over a two-year period. The unit of randomisation is the school. Schools will be allocated to intervention or wait-list control groups using a computer-generated list. Data will be collected at three time points: baseline, end of year one, and end of year two of programme implementation. Primary outcomes will include: children's understanding of key programme concepts, self-efficacy to keep safe in situations of maltreatment, anxiety arising from programme participation, and disclosure of maltreatment. Secondary outcomes include teachers' comfort and confidence in teaching the programme and parents' confidence in talking to their children about programme concepts. DISCUSSION:This RCT will address gaps in current practice and evidence regarding school based child maltreatment prevention programmes. This includes the use of a whole- school approach and multi-component programme that addresses all maltreatment concepts, a two-year period of programme implementation, and the tracking of outcomes for children, parents, and teachers. Methodologically, it will extend our understanding and learning in: capturing sensitive outcome data from young children, adapting and using standardised measures with children of different ages, the use of school level administrative data on staff reports/children's disclosure of maltreatment as behavioural outcomes, and the conduct of complex trials within the busy school environment. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02961010 (Retrospectively registered 8 November 2016).

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Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial.

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