Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
01/10/2007
Last edited
26/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We aim of this study is to test whether a school-based depression prevention programme developed in Australia, the Resourceful Adolescent Programme (RAP), is effective at reducing depressive symptoms in high-risk children in the UK.

Who can participate?
Children aged 13-16 from 9-12 mixed comprehensive schools in Bath, Bristol, Nottingham and Swindon

What does the study involve?
Participants complete a questionnaire. Their scores are used to categorise them as either low or high risk of depression or probably depressed. We want to find out what happens to the high risk group (about 20% of each class). Whole classes of children are randomly assigned to receive either the RAP, a placebo (dummy) intervention, or treatment as usual (Personal Health and Social Education - PHSE). For RAP and the placebo intervention each student has a workbook and sessions are led by trained and supervised mental health professionals. We assess children's mood, negative thoughts and self-image before we start and again at 6 and 12 months. This allows 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 work out how much it costs and what it saves.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Royal United Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2008 to December 2011

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof. Paul Stallard
paul.stallard@awp.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Stallard

ORCID ID

Contact details

Department of Child and Family Psychiatry
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
+44 (0)1225 383860
paul.stallard@awp.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/37/04

Study information

Scientific 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

Acronym

Study hypothesis

Group based CBT delivered in schools is effective and cost effective in preventing depression in adolescents at high risk of depression.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/063704
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/51378/PRO-06-37-04.pdf

Ethics approval

University of Bath Ethical Committee: School for Health: School Research Ethics Approval Panel (SREAP), 18/12/2007

Study design

Cluster randomised controlled trial.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Depression

Intervention

Interventions will be provided during the usual Personal, Social and Health Education (PSHE) sessions (1 hour per session, total of 11 sessions over one school term).

Arm A: Group CBT. CBT recognises the importance of negative thoughts and low self-worth/image in the onset and maintenance of depression. These are therefore actively targeted during CBT with core treatment components including psycho education, identifying and challenging negative/dysfunctional thoughts, identifying personal strengths (thereby enhancing self-esteem/image), managing social problems, and learning to problem solve.

Arm B: Attention placebo. The attention placebo intervention will involve similar time and contact with an external group leader but will not include the active components of the CBT intervention. The content will be based upon the PSHE provided in schools but will be provided by leaders from outside of the school. This will therefore control for the non-specific effects of interventions that are considered important in studies of depression.

Arm C: Usual PSHE

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes in depression symptoms as assessed by the short form Mood and Feelings Questionnaire at 12 months follow-up.

Secondary outcome measures

1. Changes in self-image and negative thoughts. These will be assessed at 12 months by the following questionnaires:
1.1. Self Image Profiles (SIP-A). An easily competed 25-item scale for adolescents assesses how they perceive themselves and how they would like to be. Twelve items assess positive attributes (e.g. confident, fun to be with), twelve assess negative attributes (e.g. annoying, moody) and one is neutral (i.e. feel different from others).
1.2. Children's Automatic Thoughts Scale (CATS). This self-completed scale assesses a range of negative self statements in children and young people aged 7-16. For each item the child is asked to rate whether they have had a similar thought over the past week. Each item is rated as "not at all" (scores 0), "sometimes" (scores 1), "fairly often" (scores 2), "often" (scores 3) or "all the time" (scores 4). The 10-item personal failure sub-scale will be used.
2. Cost effectiveness at 12 months

Overall trial start date

01/09/2008

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All children aged 13-16 attending participating schools (n = 8-12)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

5,000 children of whom 1,000 will be at "high risk" of depression.

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/09/2008

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal United Hospital
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

University of Bath (UK)

Sponsor details

School for Health
Bath
BA2 7AY
United Kingdom

Sponsor type

University/education

Website

http://www.bath.ac.uk/health/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21114808
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24172024
2014 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/24813670

Publication citations

  1. Results

    Stallard P, Montgomery AA, Araya R, Anderson R, Lewis G, Sayal K, Buck R, Millings A, Taylor JA, Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE)., Trials, 2010, 11, 114, doi: 10.1186/1745-6215-11-114.

  2. Results

    Stallard P, Phillips R, Montgomery AA, Spears M, Anderson R, Taylor J, Araya R, Lewis G, Ukoumunne OC, Millings A, Georgiou L, Cook E, Sayal K, A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents., Health Technol Assess, 2013, 17, 47, vii-xvii, 1-109, doi: 10.3310/hta17470.

  3. Anderson R, Ukoumunne OC, Sayal K, Phillips R, Taylor JA, Spears M, Araya R, Lewis G, Millings A, Montgomery AA, Stallard P, Cost-effectiveness of classroom-based cognitive behaviour therapy in reducing symptoms of depression in adolescents: a trial-based analysis., J Child Psychol Psychiatry, 2014, doi: 10.1111/jcpp.12248.

Additional files

Editorial Notes

26/05/2016: Plain English summary added. 29/04/2008: due to a delay in ethics approval, the overall trial start and end dates were updated again. The previous dates were: Overall trial start date: 01/01/2008. Overall trial end date: 30/04/2012. 11/01/2008: the overall trial end date was changed from 30/04/2012 to 30/04/2011.