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Prevention of Depression and Anxiety in Adolescents with a High Familial Risk.


- candidate number14030
- NTR NumberNTR3720
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2012
- Secondary IDs 
- Public TitlePrevention of Depression and Anxiety in Adolescents with a High Familial Risk.
- Scientific TitlePrevention of Depression and Anxiety in Adolescents with a High Familial Risk.
- ACRONYM
- hypothesisThe effectiveness of an indicated indicated depression and anxiety prevention program ('Een Sprong Vooruit') will be tested in a Dutch sample of adolescents (aged 12-16) with high familial risk. It is expected that the adolescents who receive the intervention will show lower levels of depressive and anxiety symptoms during follow-up, compared to the control group.
- Healt Condition(s) or Problem(s) studiedPrevention, Depression, Anxiety, Adolescents, Parental psychopathology
- Inclusion criteria- adolescent is aged between 11-15 years old;
- shows increased levels of depression and or anxiety;
- at least one of the parents shows symptoms of a depression or anxiety disorder;
- both adolescent and parents have sufficient knowledge of the Dutch language
- Exclusion criteria- absence of parental permission;
- adolescent already receives treatment for mental health problems
- presence of prominent suicide ideation (score of 2 CDI 2 suicide item)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-mrt-2015
- Target number of participants166
- InterventionsThe children with symptoms of depression and/or anxiety and with parents with elevated levels of depression and/or anxiety randomly assigned to the intervention or control condition. Participants in the intervention condition receive the program, consisting of 6 sessions of 90 minutes that will be implemented at school. Participants in the intervention and participants in the control condition will fill in questionnaires at six moments during the study. After the study, adolescents in the control condition will also get the chance to follow the lessons.
- Primary outcome1. Depression;
- Secondary outcome- Anxiety - Suicidal ideation - Response style - Cognitive errors - Relational support - Parental psychopathology - Parenting stress - Child depression according to parents - Child anxiety according to parents
- Timepoints1. Baseline;
2. Intervention phase 1 (after session 2);
3. Intervention phase 2 (after session 4);
4. Post-intervention (after session 6);
5. Follow-up 1 (6 months);
6. Follow-up 2 (12 months).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.P.A. Rasing
- CONTACT for SCIENTIFIC QUERIESProf. Dr. R.C.M.E. Engels
- Sponsor/Initiator GGZ Oost Brabant
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn this randomized controlled trial (RCT with 2 conditions, intervention and control group) the effectiveness of an indicated and selective prevention program aimed at depression and anxiety for adolescents (aged 11-15) with high familial risk will be tested. Adolescents in the intervention condition receive the program consisting of the 6 sessions of 90 minutes that will be implemented at school. Measurements of primary and secondary outcomes will be conducted in the intervention and control group at baseline, immediately after each session 2, 4 and 6 (post-intervention), at 6 months and 12 months follow-up.
- Main changes (audit trail)- Hypothesis: 11-15 instead of 12-16
- Target number of participants: daar staat 160 instead of 166.
- RECORD24-nov-2012 - 6-nov-2013


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