|- candidate number||10002|
|- NTR Number||NTR2967|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jul-2011|
|- Secondary IDs||ECG16122010 METC Radboud University Nijmegen|
|- Public Title||Variations in effectiveness of a cognitive-bahavioral therapy for clinically anxious children. |
|- Scientific Title||Variations in effectiveness of a cognitive-bahavioral therapy for clinically anxious children. |
|- hypothesis||The effectiveness of a manualized cognitive-behavioral treatment (CBT) for clinically anxious children will be tested in a sample of Dutch children (aged 8-12 years) who are assigned to one of three Dutch community agencies in Arnhem and Nijmegen. It is expected that children who receive the manualized treatment will show lower levels of anxiety symptoms compared to the control group, which will receive treatment as usual by the institutions. |
|- Healt Condition(s) or Problem(s) studied||Anxiety, Anxiety disorders, Children, Parent-child interaction, Therapeutic alliance|
|- Inclusion criteria||Children between the age of 8 and 12 with:|
1. General anxiety disorder;
2. Seperation anxiety disorder;
3. Social anxiety disorder;
4. Anxiety disorder NOS.
Above the cutt-off score of the short version of the SCARED.
|- Exclusion criteria||Children with:|
1. Specific phobia;
2. Obsessive compulsive disorder;
3. Post traumatic stress disorder;
5. IQ below 80.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||110|
|- Interventions||Children will be randomly assigned to the experimental or control group. |
Children in the experimental group will receive a manualized cognitive behavioral treatment for anxiety disorders developed and tested by Bogels and colleagues (Bodden et al., 2008).
Children in the control group will receive treatment as usual in the institution for the same period of time (12-15 weeks).
|- Primary outcome||1. Anxiety symptom levels on the SCARED;|
2. Internalizing problems on the CBCL/TRF;
3. Diagnoses based on the DAWBA.
|- Secondary outcome||1. Mother-child interaction;|
2. Therapeutic alliance;
3. Externalizing problems on the CBCL/TRF;
4. Maternal psychopathology.
|- Timepoints||1. Baseline;|
2. Posttreatment (3 months after intervention);
3. Follow-up (after 1 year).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Msc. M.E.M. Doorn, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. I. Granic|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, Pro Persona Jeugd Arnhem, Pro Persona Jeugd Nijmegen, Ambulatorium Kinder, Jeugd en Jongvolwassenen (Radboud University)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The present project aims to examine variations in effectiveness of cognitive-behavioral therapy in clinically anxious children. The effectiveness of a manualized cognitive-behavioral treatment for childhood anxiety disorders will be compared with treatment as usual within community agencies. It is expected that the manualized cognitive-behavioral treatment will provide less anxiety symptoms after treatment and at follow-up compared to treatment as usual. |
|- Main changes (audit trail)|
|- RECORD||4-jul-2011 - 30-aug-2011|