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van CCT (UK)

van CCT (UK)

VRIENDEN voor het Leven.
FRIENDS for Life.

- candidate number8191
- NTR NumberNTR2397
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2010
- Secondary IDsNL32979.029.10 / 50-50405-98-142 ; CCMO / ZonMw
- Public TitleVRIENDEN voor het Leven.
FRIENDS for Life.
- Scientific TitleFRIENDS for Life: Process and effect evaluation of an indicated school-based prevention programme for childhood anxiety and depression.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedDepressive disorders, Anxiety disorders, Prevention
- Inclusion criteria10 children of grade 7 and 8 of Dutch primary school (age 10-12) scoring highest on the Revised Anxiety and Depression Scale (RCADS) and identified by teacher and care coordinator as having mild symtoms of anxiety and/or depression.
- Exclusion criteria1. Presence of a clinical anxiety or depressive disorder;
2. Externalising behaviour problems;
3. Substantial learning disabilities or a developmental delay (teachers’ evaluations);
4. Children who are not willing or not motivated to participate in the programme.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 19-aug-2010
- planned closingdate1-jun-2012
- Target number of participants200
- InterventionsFRIENDS for Life is a cognitive-behavioural programme that teaches children the skills to cope more effectively with feelings of anxiety and depression and builds emotional resilience, problem-solving abilities and self-confidence. The programme is based on the theoretical model of prevention and early intervention of anxiety, which addresses cognitive, psychological and behavioural processes that interact in the development, maintenance and experience of anxiety. FRIENDS for Life consists of 10 weekly sessions plus 1 booster sessions. Booster session 1 will be held one month after finishing the programme. The programme also includes 2 parent sessions. Parent sessions will be held after session 3 or 4 of the programme. A FRIENDS for Life group consists of about ten children aged 10-12 years (grades 7 and 8 of Dutch primary schools) and is run by two prevention workers per group. Prevention workers of a local mental health care organisation organise and conduct the programme.

Control group: Care as usual.
- Primary outcomeSymptoms of anxiety and depression.
- Secondary outcome1. Programme integrity;
2. Children’s evaluation of the programme;
3. Parent’s evaluation of the programme;
4. Response to FRIENDS for Life in gender, age, and ethnic group.
- TimepointsOutcome name: RCADS.
Timepoints: Pre-intervention, immediately after intervention, 6 months after intervention, 12 months after intervention.

Outcome name: Peer-nominations.
Timepoints: Pre-intervention, immediately after intervention, 6 months after intervention, 12 months after intervention.

Methods of measurement:
1. Questionnaires:
A. Revised Anxiety and Depression Scale (RCADS);
B. Peer-nomination measure.
2. Programme-integrity:
A. Observations;
B. Programme and attendance logs.
3. Parents'evaluation: Telephone interviews;
4. Childrens' evaluations: Online focusgroups.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center, GGD Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe aim of the project is to evaluate the effectiveness of FRIENDS for Life as selective school-based prevention programme for children aged 8-12 years with early or mild signs of anxiety or depression. Various aspects of the programme’s effectiveness and implementation will be investigated:
1. This controlled trial includes a pre-intervention assessment and three follow-up assessments (directly after, and 6 and 12 months after the end of the programme). The primary outcome measure is symptoms of anxiety and depression;
2. We will investigate whether differences occur in the extent to which specific groups of children (with regard to severity of symptoms at the start of the programme, gender, age, and ethnic group) benefit from FRIENDS for Life;
3. A process evaluation will be conducted to investigate whether the programme has been executed according to protocol (programme integrity) and to evaluate children’s and parents’ opinions about FRIENDS for Life using online focus groups and interviews.

Countries of recruitment: the Netherlands.
- Main changes (audit trail)
- RECORD30-jun-2010 - 24-mrt-2011

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