|- candidate number||9492|
|- NTR Number||NTR2916|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mei-2011|
|- Secondary IDs||P05.1639L/MEC 05-147 / 170881006; AZM / ZonMW|
|- Public Title||Treatment of anxiety disorders in children with Autism Spectrum Disorders (ASD).|
|- Scientific Title||Treatment of anxiety disorders in children with autistic-spectrum Disorders (ZonMw).|
Cognitive Behavioral therapy for anxiety disorders in children with and without developmental disorders (MEC).
|- hypothesis||The aims of the study are:|
1. To compare the effectiveness of Cognitive Behavioral Therapy (CBT) for anxiety disorders between children with ASD and children without ASD;
2. To compare the (cost-) effectiveness of CBT to Treatment As Usual (TAU) for anxiety disorders in children with ASD.
No hypotheses are prepared (hypotheses are exploratory).
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders, Cognitive behavior therapy, Autism Spectrum Disorders (ASDs)|
|- Inclusion criteria||1. Children, aged 7-18, must have at least one anxiety disorder (all anxiety disorder are included), according to parent and/or child report;|
2. At least one parent is willing to participate in treatment and research.
|- Exclusion criteria||1. Acute suicidal behavior;|
2. Untreated psychotic disorder;
3. IQ below 70;
4. DSM-IV V-code of current sexual or physical abuse;
5. Having had CBT for anxiety disorders in the past year.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||3-feb-2006|
|- planned closingdate||1-jun-2013|
|- Target number of participants||200|
|- Interventions||The study has two arms. The first arm of the study consists of a comparison between children with anxiety disorders, with and without ASD. These children receive the same intervention (CBT). The second arm of the study consists of a comparison between CBT and Treatment As Usual (TAU) for anxiety disorders in children with ASD. For an outline of the interventions, see below.
Cognitive Behavioral Therapy (CBT):
The individual, standardized CBT (Denken + Doen = Durven; Bögels, 2008) consists of 15 sessions within approximately 3 months. There are 12 child sessions and three parent sessions. Its main ingredients are: psycho-education about anxiety, challenging anxious thoughts, exposure with a reward system, behavior experiments, and prevention of relapse. The intervention is delivered by trained therapists, who receive within- and across center training.
Treatment as Usual (TAU):
Interventions that fall under the umbrella of TAU are: psycho-education, parent guidance, school guidance, social skills training, group trainings, family counseling, behavior therapy, individual therapy (not being CBT), and medication.
|- Primary outcome||1. Diagnostic status: whether the child still meets criteria for its (primary) anxiety disorder (ADIS);|
2. Anxiety symptomatology (SCARED);
3. Quality of Life (QoL; EQ-5D);
4. Costs (measured by a retrospective costs-questionnaire).
|- Secondary outcome||1. General psychopathology (CBCL);|
2. ASD-related symptoms (CSBQ);
3. Family Functioning (FFS & FAST);
4. Parental rearing behavior (CDQ);
5. Parental anxiety (SCARED);
6. Parental quality of life (EuroQol);
7. Attachment (AQ).
|- Timepoints||For all participants at least three assessments are conducted: At pre- and post treatment, and three months after treatment (follow up 1). For the participants in the CBT-condition, a follow up one year after treatment (follow up 2) and a follow up two years after treatment (follow up 3) are conducted.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Bonny Steensel, van|
|- CONTACT for SCIENTIFIC QUERIES|| Bonny Steensel, van|
|- 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||N/A|
|- Main changes (audit trail)|
|- RECORD||25-mei-2011 - 5-jun-2011|