|- candidate number||2904|
|- NTR Number||NTR1143|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2007|
|- Secondary IDs||2001-2-1306 ZonMW|
|- Public Title||Prevention of childhood anxiety disorders via the parent or via the child?|
|- Scientific Title||Prevention of childhood anxiety disorders: A comparison of the effects of child cognitive-behaviour intervention, parental cognitive-behaviour intervention, and no intervention in a Dutch community sample of at-risk children.|
|- hypothesis||It is hypothesized that
1. both interventions are more effective than no intervention;|
2. parent CBT is more effective than child CBT if parents suffer from anxiety;
3. if untreated, at-risk children develop substantially more AD than not at-risk children;
4. if untreated, at-risk children develop more AD in case their parents are anxious.
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders in youth|
|- Inclusion criteria||1. SCARED score in the highest 15%;|
2. IQ above 80;
3. age 8-12;
4. Normal elementary school.
|- Exclusion criteria||1. Do not sufficiently master the Dutch language;|
2. have substantial learning problems or a developmental delay.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2004|
|- planned closingdate||1-mrt-2009|
|- Target number of participants||128|
|- Interventions||We compare:|
1. natural course;
2. parent training (parent CBT group);
3. child training (group CBT).
|- Primary outcome||Number of children that have not developed anxiety disorders.|
|- Secondary outcome||SCARED anxiety symptom level.|
|- Timepoints||1. Pretest (followed by intervention or natural course);|
2. follow-up I (1 year after pretest);
3. follow-up II (2 year after pretest).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. Ellin Simon|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Susan Bogels|
|- Sponsor/Initiator ||University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The present project aims to develop and evaluate interventions to prevent childhood anxiety disorders (AD) in children "at risk" for developing AD. The effectiveness of a cognitive-behavioral (CBT) intervention for parents will be compared with a CBT intervention for children and with no intervention (natural course) in at risk children. It is expected that the parent intervention is superior to the child intervention, in case the parents are anxious. In the at risk no intervention group, it is tested whether parental anxiety is a risk factor for child AD to develop. Furthermore, the cost-effectiveness of the screening, of intervention versus no intervention, and of the parent- versus child-based intervention is evaluated. The effectiveness of the screening to detect at risk children will be investigated, by comparing the natural course of at risk children with the natural course of not at
risk children. Based on a screening for anxiety symptoms of 3000 children aged 8-12, 156 at risk children will be selected and 52 not at risk children. The at risk children are randomly assigned to either the parent intervention (n=52), the child intervention (n=52), or no intervention (n=52). The not at risk children receive no intervention. All children are followed for 2 years, assessments take place before the intervention (pretest), 1 year and 2 years after pretest. The primary outcome parameter is the number of children who do not develop AD.
|- Main changes (audit trail)|
|- RECORD||27-nov-2007 - 3-apr-2008|