No registrations found.
ID
Source
Health condition
Depression, Suicide, Prevention, Adolescents, School-based
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depressive symptoms: Child Depression Inventory 2 (CDI 2) and Anxiety Disorder Interview Schedule for Children (ADIS-C; section of affective disorders)
Secondary outcome
1. 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)
Background summary
In 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.
Study objective
The 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.
Study design
1. 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)
Intervention
The 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.
Karlijn Heesen
Oss 5342 JW
The Netherlands
0412 – 84 7001
kwj.heesen@ggzoostbrabant.nl
Karlijn Heesen
Oss 5342 JW
The Netherlands
0412 – 84 7001
kwj.heesen@ggzoostbrabant.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5618 |
NTR-old | NTR5725 |
Other | NL55328.091.15 : 2016-02 CMO Arnhem-Nijmegen |