|- candidate number||14063|
|- NTR Number||NTR3737|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2012|
|- Secondary IDs||2012-2711-069 ECG|
|- Public Title||A randomized controlled trial comparing school-based (Op Volle Kracht) and computerized (SPARX) depression prevention programs with adolescent girls.|
|- Scientific Title||A randomized controlled trial comparing school-based (Op Volle Kracht) and computerized (SPARX) depression prevention programs with adolescent girls.|
|- hypothesis||The effectiveness of school-based ('Op Volle Kracht') and computerized ('SPARX') depression prevention programs will be tested in a Dutch sample of adolescent girls with elevated depressive symptoms. The programs will be tested separately and combined. It is expected that the adolescent girls who receive one or both of the interventions will show lower levels of depressive symptoms during posttreatment and follow-up, compared to the control group.|
|- Healt Condition(s) or Problem(s) studied||Depression, Prevention, Adolescents|
|- Inclusion criteria||1. Adolescent girls in 7th and 8th grade, middle school (ages 12-14);|
2. Informed consent from children and parents;
3. Elevated depressive symptoms. In line with other indicated prevention studies (see for a meta-analytic review Horowitz & Garber, 2009) and earlier studies with the SPARX (Fleming et al., 2012; Merry et al., 2012; Lucassen et al., in preparation) girls with a RADS-2 score of above the 70th percentile will be included.
|- Exclusion criteria||1. No informed consent from children and parents;|
2. Children with severe depressive score and suicidal ideation (score 3 on item 9 of the CDI);
3. Children currently receiving mental health care.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-mei-2014|
|- Target number of participants||200|
|- Interventions||Girls with elevated depressive symptoms are randomly assigned to one of four conditions. |
1. The first condition, 'Op Volle Kracht', will consist of the first 8 lessons of 50 minutes of the 'Op Volle Kracht' program (including homework assignments), which the girls will receive at their school during or after school time under supervision of a psychologist.
2. In the second condition, ‘SPARX’, girls play one 30 minute level of the ‘SPARX’ video game at home each week, until they have completed all seven levels.
3. The third condition, ‘Op Volle Kracht and SPARX’, consists of both the first 8 lessons of ‘Op Volle Kracht’ (as received by the girls in the first condition) and the seven levels of ‘SPARX’ (as received by the girls in the second condition).
4. Finally, the control condition, will receive an intervention after the completion of the study (either OVK or SPARX), but no intervention during the study. Participating girls in all conditions fill out weekly questionnaires during the programs.
|- Primary outcome||Depressive symptoms: Reynolds Adolescent Depression Scale Second Edition (RADS-2).|
|- Secondary outcome||1. Daily stressors. Daily stressors will be measured by asking adolescents if they experienced a negative event last week. Questions include what kind of event it was, who was involved in the event, what emotion(s) were most prominent during the event, what the intensity was of the emotion and if the stress from the event has been resolved or not;|
2.. Motivation. Adapted version of the Autonomous and Controlled Motivations for Treatment Questionnaire (ACMTQ);
3. Cognitive coping. Cognitive Emotion Regulation Questionnaire (CERQ);
4. Cognitive errors. Revised Children’s Negative Cognitive Errors Questionnaire (CNCEQ-R);
5. Active coping. Brief-COPE;
6. Self-efficacy. Self Efficacy Questionnaire for Children (SEQ-C);
7. Hopefulness. General Positive Expectancies (GPE);
8. Theory of emotion. Implicit Theory of Emotion scale (ITE);
9. Depression Anxiety Stress Scale (DASS 21).
|- Timepoints||1. Screening (all primary and secondary outcomes);|
2. Pretreatment (all primary and secondary outcomes);
3. Immediately after each lesson (Depressive symptoms (RADS-2); Suicidal ideation; Daily stressors);
4. Midtreatment (all primary and secondary outcomes);
5. Posttreatment (all primary and secondary outcomes);
6. Three months after the last lesson (follow-up; all primary and secondary outcomes);
7. Six months after last lesson (all primary and secondary outcomes);
8. Twelve months after last lesson(all primary and secondary outcomes).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Marlou Poppelaars|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Anna Lichtwarck-Aschoff|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud Universiteit Nijmegen, Behavioural Science Institute|
|- Brief summary||In this randomized controlled trial (RCT with 4 conditions, 3 intervention conditions and control group), the effectiveness of school-based ('Op Volle Kracht') and computerized ('SPARX') depression prevention programs will be tested in a Dutch sample of adolescent girls with elevated depressive symptoms. Girls with elevated depressive symptoms are randomly assigned to one of four conditions. The first condition will consist of 8 lessons of 50 minutes at school during or after school time. The second condition consists of seven 30 minute levels of a video game which girls play at home. The third condition consists of both the 8 school-based lessons and the seven levels of the video game. Measurements of primary and secondary outcomes will be conducted in all groups at baseline, immediately after each lesson, three, six and twelve months after the last lesson.|
|- Main changes (audit trail)|
|- RECORD||5-dec-2012 - 28-dec-2012|