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A Randomized Controlled Trial Testing the Effectiveness of an Indicated Depression Prevention Program ('Op Volle Kracht') Among Adolescent Girls with Elevated Depressive Symptoms.


- candidate number10498
- NTR NumberNTR3126
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2011
- Secondary IDs2011-01 Stichting Olim
- Public TitleA Randomized Controlled Trial Testing the Effectiveness of an Indicated Depression Prevention Program ('Op Volle Kracht') Among Adolescent Girls with Elevated Depressive Symptoms.
- Scientific TitleA Randomized Controlled Trial Testing the Effectiveness of an Indicated Depression Prevention Program ('Op Volle Kracht') Among Adolescent Girls with Elevated Depressive Symptoms.
- ACRONYM
- hypothesisThe effectiveness of a school-based indicated depression prevention program ('Op Volle Kracht') will be tested in a Dutch sample of adolescent girls with elevated depressive symptoms (aged 12-14 years). It is expected that the adolescent girls who receive the intervention will show lower levels of depressive symptoms during follow-up, compared to the control group. Moreover, we will examine whether implicit self-esteem predicts or mediates treatment outcome.
- Healt Condition(s) or Problem(s) studiedDepression, Prevention, Adolescents, Implicit self-esteem
- Inclusion criteria1. Adolescents in 8th grade, middle school (ages 12-14);
2. Middle school grade 8 (VMBO-t, HAVO, VWO, Gymnasium);
3. Informed consent from children and parents;
4. CDI-score > 16.
- Exclusion criteria1. Parents (on behalf of their child) do not allow their child to participate in the study;
2. Children with CDI-score > 19 and suicidal ideation (score 2 on item 9).
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-jul-2012
- Target number of participants100
- InterventionsThe girls with elevated depressive symptoms of the participating schools are at random assigned to the intervention or control condition. The participating girls in the intervention condition receive the program, consisting of the first 8 lessons of 50 minutes that will be implemented after schooltime. They will also fill in questionnaires after each lesson. The participating girls in the control condition will only fill in the questionnaires at the same time points. After the study, they will also get the chance to follow the lessons.
- Primary outcome1. Implicit Self-esteem: Implicit Association Task (IAT);
2. Depressive symptoms: Child Depression Inventory (CDI).
- Secondary outcome1. Implicit Self-esteem: Name Letter Task (NLT);
2. Depressive symptoms: Center for Epidemiologic Studies Depression Scale (CES-D scale);
3. Self-esteem: Rosenberg Self-Esteem Scale (RSES);
4. Self-esteem: State Self-Esteem Scale (SSES);
5. Anxiety: State Trait Anxiety Inventory (STAI);
6. Positive & Negative affect: Positive and Negative Affect Schedule (PANAS);
7. Relationship best friend;
8. Loneliness: UCLA loneliness scale (UCLA);
9. Emotional Eating Behaviour: Nederlandse Vragenlijst voor Eetgedrag (NVE);
10. Psychopathology Parents.
- Timepoints1. 0 (start);
2. Immediately after each lesson;
3. One month after last lesson (follow-up);
4. Six months after last lesson.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lieke Wijnhoven
- CONTACT for SCIENTIFIC QUERIESDrs. Daan Creemers
- Sponsor/Initiator GGZ Oost Brabant
- Funding
(Source(s) of Monetary or Material Support)
Stichting Olim
- PublicationsN/A
- Brief summaryIn this randomized controlled trial (RCT with 2 conditions, intervention and control group) the effectiveness of an indicated depression prevention program for adolescent girls with elevated depressive symptoms (12-14 years of age) will be tested. Adolescents in the intervention condition receive the program consisting of the first 8 lessons of 50 minutes that will be implemented after schooltime. Measurements of primary and secondary outcomes will be conducted in the intervention and control group at baseline, immediately after each lesson and one month after the last lesson.
- Main changes (audit trail)
- RECORD3-nov-2011 - 17-dec-2011


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