Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
A single blind randomised controlled trial to determine the effectiveness of group cognitive behaviour therapy (CBT) in the prevention of depression in high risk adolescents |
Project ref: |
06/37/04 |
Cost: |
£1,029,065 |
Chief Investigator : |
Professor Paul Stallard, Professor, Child and Family Mental Health, School for Health, University of Bath |
Start Date: |
September 2008 |
Estimated date of publication in HTA journal series: |
Early 2013. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
THE RESEARCH: We aim to test whether a school based depression prevention programme developed in Australia, the Resourceful Adolescent Programme (RAP), is effective in reducing depressive symptoms in high risk children in the UK. Children aged 13-16 from 9-12 mixed comprehensive schools in Bath, Bristol, Nottingham and Swindon will complete a screening questionnaire. These scores will be used to categorise children as either low risk, high risk of depression or probably depressed. We want to find out what happens to the high risk group (approximately 20% of each class). Whole classes of children will be randomly assigned to receive RAP, a placebo intervention or treatment as usual (Personal Health and Social Education - PHSE). For RAP and the attention placebo each student will have a workbook and sessions will be led by trained and supervised mental health professionals. We will assess children's mood, negative thoughts and self image before we start (at baseline) and again at 6 & 12 months. This will help us to see whether RAP is effective and if these gains last. We also want to find out whether RAP is good value and so we will work out how much it costs and what it saves. ETHICAL ISSUES: The interventions will be provided as part of the school curriculum and so all children will take part. However, only those who provide signed consent/assent will complete questionnaires. Those children/carers who score highly on the questionnaire assessing mood (i.e. suggesting possible clinical depression) will be contacted and advised to contact their GP if they would like further help. In each locality there will be a qualified mental health expert who can be contacted if concerns about the mental health of a child arise during the project. EXPERTISE OF TEAM: We are experienced in using prevention programmes with children in schools and in undertaking large studies. We have links with three Universities (Bath, Bristol, Plymouth & Exeter); experienced statistician who can analyse our data and who has links with a Clinical Trials Unit; a health economist who can look at costs and cost benefits; a service user who can provide a user perspective and experienced clinicians in each area who can help if any concerns arise. COSTS: These include researcher, academic & user time, materials, travel, stationary and office/computing costs. |
Project Abstract: |
Classes of children aged 13-16 will be randomised to one of three, 10 week, Personal Social Health and Education (PSHE) conditions. The experimental condition will be based upon cognitive behaviour therapy and will specifically target depressive cognitions and mood. The second will be an attention control condition involving similar time and contact with external group leaders but will not include the active components of the CBT intervention. The third will be treatment as usual, i.e. PSHE delivered by the school. Symptoms of depression (Mood and Feelings Questionnaire), cognitions (Children's Automatic Thoughts Scale) and self-image (Self Image Profile) will be assessed at baseline, 6 and 12 months and an economic evaluation undertaken at 12 months. The primary analysis will explore the preventative effect of the intervention on children identified as "at risk" of depression i.e. those scoring high on the Mood and Feelings Questionnaire at initial screen and baseline assessment. Secondary analysis will explore the effect upon cognitions and self-image. Finally the preventative effects upon all participating students and the impact of possible mediating mechanism of self-harm, drug and alcohol misuse will be investigated. |
ISRCTN* number: | ISRCTN 19083628 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN19083628 |
Project Protocol: |
Project protocol (pdf format, 250 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1667 |
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