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Strong teens and resilient minds: School-based prevention of depression and suicide


- candidate number24104
- NTR NumberNTR5725
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2016
- Secondary IDs2016-02 CMO Arnhem-Nijmegen NL55328.091.15
- Public TitleStrong teens and resilient minds: School-based prevention of depression and suicide
- Scientific TitleStrong teens and resilient minds: School-based prevention of depression and suicide
- ACRONYM
- hypothesisThe effectiveness of a school-based indicated depression prevention program ('Op Volle Kracht') will be tested in a Dutch sample of adolescents with elevated depressive symptoms (aged 12-14 years). It is expected that the adolescents who receive the intervention will show lower levels of depressive symptoms during follow-up, compared to the control group. Moreover, it is expected that the intervention will be cost-effective and screening and intervening will reduce suicide risk.
- Healt Condition(s) or Problem(s) studiedDepression, Suicide, Adolescents, Prevention
- Inclusion criteria1. Adolescents in their second year of secondary school (11-15 years)
2. Informed consent from children and parents
3. Sufficient knowledge of the Dutch language
4. CDI 2-score > 14.
- Exclusion criteria1. Absence of parental permission
2. Adolescent already receiving treatment for mood problems
2. Children with suicidal ideation (score 2 on item 8 CDI 2) or servere depression (measured with clinical interview) will be excluded from the intervention
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jul-2020
- Target number of participants160
- InterventionsThe adolescents with symptoms of depression will be randomly assigned to the intervention or control condition. Participants in the intervention condition receive the program, consisting of 8 sessions of 60 minutes that will be implemented at school. Participants in the intervention and participants in the control condition will fill in questionnaires at seven moments during the study. After the study, the participants in the control condition will also get the chance to follow the lessons.
- Primary outcomeDepressive symptoms: Child Depression Inventory 2 (CDI 2) and Anxiety Disorder Interview Schedule for Children (ADIS-C; section of affective disorders)
- Secondary outcome1. Suicidal ideation: item 8 of CDI 2
2. Anxiety: State Trait Anxiety Inventory (STAI)
3. Suicide risk: VOZZ-Screen
4. Healthcare costs: cost diary (Bodden et al., 2008; Stikkelbroek et al., 2013)
5. Health Status: EQ-5D-5L
6. Somatic complaints: Children’s Somatization Inventory (CSI)
7. Cognitive errors: The Children’s Negative Cognitive Errors questionnaire-Revised (CNCEQ-R)
8. Independant and personal negative life-events: The Adolescent Live Event Questionnaire-Revised (ALEQ-R)
9. Academic functioning: School grades, drop-outs, non-attendance, and truancy (obtained in collaboration with schools)
10. Depression symptoms according to the parents: Child Depression Inventory 2 for parents (CDI 2-P)
- Timepoints1. Baseline
2. Post-intervention (after session 8)
3. Follow-up 1 (6 months)
4. Follow-up 2 (12 months)
5. Follow-up 3 (24 months)
6. Follow-up 4 (36 months)
7. Follow-up 5 (48 months)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Karlijn Heesen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rutger 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 prevention program aimed at depression will be tested. Adolescents in their second year of secondary school (11-15 years) will be screened for depression by the mental health service of school (GGD). Adolescents with presence of suicidal ideation or severe depressive symptoms will be seen and eventually redirected to mental health care. Adolescents with clinical level of depressive symptoms will be randomly assigned to the experimental and control condition. Participants in the experimental condition will receive the prevention program ‘Op Volle Kracht’ consisting of 8 sessions of 60 minutes that will be implemented at school. Participants in the control condition will receive psycho-educational information. Measurements of primary and secondary outcomes will be conducted in the intervention and control group at baseline, post-intervention, at 6-, 12-, 24-, 36-, and 48 months follow-up.
- Main changes (audit trail)
- RECORD11-mrt-2016 - 9-mei-2016


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