|- candidate number||14261|
|- NTR Number||NTR3818|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jan-2013|
|- Secondary IDs||ECG2012-0910-053 RU|
|- Public Title||Test of the effectiveness and underlying mechanisms of a group-based cognitive behavioural therapy-based indicative prevention program for children with elevated anxiety levels.|
|- Scientific Title||Test of the effectiveness and underlying mechanisms of a group-based cognitive behavioural therapy-based indicative prevention program for children with elevated anxiety levels.|
|- hypothesis||The main aim of this project is to conduct a Randomized Controlled Trial (RCT) to evaluate the effectiveness of an adapted and translated version of Coping Cat in the form of an indicative group-based prevention program.
The main aim of this project is to conduct a Randomized Controlled Trial (RCT) to evaluate the effectiveness of a CBT group treatment program (ďCoping CatĒ) in the form of an indicative anxiety prevention program. The second aim it to gain insight into the mechanisms underlying its effectiveness. Coping Cat will be tested in Dutch primary school children (grades 5-8) with elevated levels of anxiety. It is hypothesized that children in the intervention condition will experience reduced levels of anxiety in comparison with the control group. Three potential mediators will be examined, namely active coping, cognitions about coping and positive cognitive restructuring.
|- Healt Condition(s) or Problem(s) studied||Anxiety, Cognitive behavior therapy, Children, Coping, Cognition, Prevention, Effective elements|
|- Inclusion criteria||1. Primary school children in grades 5 till 8 (ages 7 till 12);|
2. Screening participation: passive consent from parents;
3. SCAS-C score > 1 SD;
4. After screening: Active consent from parents.
|- Exclusion criteria||1. Parents (on behalf of their child) do not allow their child to participate;|
2. Children with SCAS-P score > 1SD and high score on suicidal item CDI (score 3 on item 9);
3. Children who score above the cut off score on the obsessive compulsive disorder scale only;
4. Child who received CBT in the last year, or are currently in therapy with a CBT basis.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||28-jan-2013|
|- planned closingdate||1-jul-2014|
|- Target number of participants||130|
|- Interventions||Children randomly assigned to the intervention condition will receive a 12-session, 1-h group therapy. Therapy will take place at the schools, after regular school hours. Children will fill in questionnaires before each lesson.
Participating children in the control condition will only fill in questionnaires at the same time points. After the 3-month follow-up assessment, they will also get the chance to follow the program.
|- Primary outcome||Child and parent report:|
1. Anxiety symptoms: Spence Children's Anxiety Scale (SCAS) & Multidimensional Anxiety Scale for Children (MASC-10).
|- Secondary outcome||Child reports:|
1. Active coping: Coping StrategieŽn Lijst voor Kinderen (CSLK);
2. Positive cognitive restructuring: Coping; StrategieŽn Lijst voor Kinderen (CSLK);
3. Cognitions about coping: Coping Questionnaire Child (CQ-C);
4. Self-efficacy: Self-Efficacy Questionnaire for Children (SEQ-C).
5. Therapeutic Alliance: Therapeutic Alliance Scale (TASC).
|- Timepoints||1. Screening;|
2. Baseline (just before start intervention);
2. Directly before each lesson (child reports only);
3. Three month after last lesson (follow-up).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Manon L.A. Starrenburg, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Rutger C.M.E. Engels|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In this randomized controlled trial (RCT with 2 conditions, intervention and control group) the effectiveness of a CBT program (Coping Cat) in the form of an indicative group-based prevention will be evaluated. The second aim is to gain insight into the mechanisms underlying its effectiveness.
Primary school children (grades 5 till 8) in the intervention condition receive the program consisting of 12 lessons of 1 hour that will be implemented after school time. Measurements of primary and secondary outcomes will be conducted in the intervention and control group at baseline, directly before each lesson and at 3 months follow up.|
|- Main changes (audit trail)|
|- RECORD||28-jan-2013 - 20-jul-2015|