PHR - 09/3000/03: A cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of a school-based cognitive behavioural therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10 years
|Project title||A cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of a school-based cognitive behavioural therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10 years|
|Research type||Primary Research|
|Start date||January 2011|
|Link to journal publication|
|Chief Investigator||Professor Paul Stallard|
|Co-investigators||Professor Rob Anderson (University of Exeter), Ms Sue Anderson, Professor Harry Daniels (Oxford University), Dr Rhiannon Phillips (University of Bath), Dr Neil Simpson, Dr Gordon Taylor (University of Bath)|
|Contractor||Oxfordshire & Buckinghamshire Mental Health NHS Foundation Trust|
|Plain English summary||Why is this important? Emotional problems of anxiety and low mood in children are unfortunately common. These emotional problems have significant effects upon everyday life and increase the likelihood of further problems in adulthood. Whilst effective help is available many of these children are not recognised as needing help and so are not refereed for specialist treatment. An alternative way of helping these children is to provide emotional health interventions in schools. Reviews suggest that school based emotional health prevention programmes can be effective but these have not been evaluated in the UK. What we want to do? One school based emotional health programme that has shown particularly good results is the Australian FRIENDS programme. This programme addresses a number of the important factors identified in reviews, i.e. it is based upon a robust theoretical model (Cognitive Behaviour Therapy); teaches children a range of different skills and has sessions and information for parents. However FRIENDS has not been widely used in the UK and no robust evaluations have been undertaken to determine whether it does have a positive effect upon mood and anxiety. We want to check whether FRIENDS is effective and cost effective if delivered by a teacher or a health professional. How and where? Children aged 9/10 from approximately 45-54 schools will be allocated to either teacher led or health professional led FRIENDS or a no treatment control group. Outcomes. We will check children's anxiety, mood, self-esteem and bullying before FRIENDS, after finishing the programme and at 12 months. This will help to see whether FRIENDS is effective, if these gains last and whether teachers are as good at delivering FRIENDS as health professionals. We also want to know if FRIENDS is good value for money and so we will work out what it costs and what it saves. Ethical issues. FRIENDS will be provided as part of the standard school curriculum. However, only those children and carers who consent/assent will participate in the programme and will complete the assessments. We will have a no treatment group because we do not know whether FRIENDS is better or worse than other health promotion programmes that schools are already providing. The no treatment group will be offered the FRIENDS programme after the one year follow-up is completed. A mental health expert who is part of the local child services will be identified as the link for each local school. The mental health link will be available to discuss and offer advice about any additional help that may be required for those children identified with significant mental health problems.|
|Scientific summary||DESIGN: Randomised controlled cluster trial comparing FRIENDS (delivered by health professional or school) vs. treatment as usual for the reduction and prevention of anxiety symptoms and low mood (i.e. reduced symptoms of depression) in children aged 9/10. SETTING: 45-54 junior schools in Bath and North East Somerset and Wiltshire. INTERVENTION BEING EVALUATED: FRIENDS is a manualised cognitive behaviour therapy (CBT) programme designed to improve children's mental health. Each child has a workbook and group leaders a comprehensive manual detailing the content and structure of each session. FRIENDS involves 10, 60-minute weekly sessions delivered to whole classes as part of the school PSHE programme. FRIENDS teaches children practical skills to identify their feelings; to learn to relax; to identify unhelpful thoughts and to replace them with more helpful thoughts; and how to face and overcome their problems and challenges. Initial training and regular supervision of leaders will be provided by a specialist CBT expert. An additional session for parents/carers is provided at the start of FRIENDS to provide an overview of the programme, the CBT rationale and the skills the children will be taught. Parents will receive a sheet at the end of each session summarising what the children have discussed and the ideas they will be practicing each week so that they can reinforce and encourage their use at home. MEASUREMENT OF OUTCOMES AND DURATION OF FOLLOW-UP: (a). Psychological functioning: The primary outcomes will be reduced levels of anxiety and improved mood (i.e. reduced symptoms of depression) as assessed on continuous measures at 6 & 12 months. Secondary outcomes are improved self-esteem, and reductions in bullying. Assessments at 3 different times: Time 1, baseline; Time 2, post FRIENDS (6 months); Time 3, 12 month. Parents will complete a behavioural screening questionnaire at all 3 time points. (b). Acceptability: Children will rate FRIENDS on 10 dimensions e.g. enjoyment, acquisition and use of new skills, etc. (c). Delivery: Leaders will assess FRIENDS on factors such as child engagement, school support, etc. (d). Treatment fidelity will be assessed by observing a random selection of 10% of FRIENDS sessions and assessing whether learning points and exercises were covered. (e). Parent Interviews at baseline and 6 months: For the economic evaluation, a purposeful sample of carers/parents of 300 children, 100 from each condition, will complete the Client Receipt of Services Questionnaire about their child s use of health, social and educational services. Qualitative interviews with 20 parents from the FRIENDS group to assess how and why the intervention might benefit children e.g. changes in friendships; family relationships; educational progress and engagement in out of school social and recreational activity. (f). Cost and cost-effectiveness: an analysis comparing the two versions of FRIENDS vs. treatment as usual. The cost-effectiveness analysis will be based on the primary outcome measures. Both the cost analysis and the cost-effectiveness analysis will be from the joint perspective of the health (NHS) and education/social services sector. The research will identify, measure and value the resource consequences of each alternative (applying opportunity cost as the main principle for valuation. PLANNED ANALYSIS: Analysis and presentation of data will be in accordance with CONSORT guidelines. The primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals for the between-arm comparisons. Descriptive student- and class-level statistics will be used to ascertain any marked imbalance between the arms at baseline. The primary analysis will employ a mixed effect linear regression model to compare the active CBT interventions versus treatment as usual, adjusting for stratification variables and baseline score, and taking appropriate account of the hierarchical nature of the data (repeated measures, students, classes and schools). Sensitivity analyses making different assumptions will be conducted to investigate the potential effects of missing data. Secondary analyses will include: 1) repeating the primary analysis adjusting for any variables exhibiting marked imbalance at baseline to examine whether this influences the findings; 2) comparison of children who score high and low on anxiety and mood questionnaires at baseline to examine who most benefits form these interventions; 3) similar analyses for other secondary outcomes (using appropriate multi-level models and adjusting p-values for multiple testing); 4) investigation of process measures such as number of sessions attended. PROJECT TIMETABLE: Mth 1-2: Recruitment, establish project infra-structure. Mth 3-6: School recruitment; recruit FRIENDS leaders. Mth 7-8; Randomisation; prepare assessments. Mth 9; Training; consent. Mth 10-12: Baseline assessments; deliver interventions. Mth 13-15: data entry, cleaning and checking. Mth 16-18: Baseline analysis & 6 month assessments. Mth 19-21: 6 month data entry, cleaning and checking. Mth 22-24: analysis and 12 month follow-up. Mth 25-27: 12 month data entry, cleaning and checking. Mth 28-30: analysis. Mth 31-36: Project write up and dissemination. RECRUITMENT RATES: Local pilot work in 30 junior schools indicates that less than 1% of children opt out of FRIENDS and that approximately 90% complete baseline and follow-up assessments. Conservatively, we predict 90% of the eligible population will participate and of these 80% will complete follow-ups.|
Protocol (PDF File - 287.8 KB)
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