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Treatment of anxiety disorders in children with Autism Spectrum Disorders (ASD).


- candidate number9492
- NTR NumberNTR2916
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2011
- Secondary IDsP05.1639L/MEC 05-147 / 170881006; AZM / ZonMW
- Public TitleTreatment of anxiety disorders in children with Autism Spectrum Disorders (ASD).
- Scientific TitleTreatment of anxiety disorders in children with autistic-spectrum Disorders (ZonMw).
Cognitive Behavioral therapy for anxiety disorders in children with and without developmental disorders (MEC).
- ACRONYM
- hypothesisThe 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) studiedAnxiety disorders, Cognitive behavior therapy, Autism Spectrum Disorders (ASDs)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 3-feb-2006
- planned closingdate1-jun-2013
- Target number of participants200
- InterventionsThe 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 outcome1. 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 outcome1. 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).
- TimepointsFor 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 siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Bonny Steensel, van
- CONTACT for SCIENTIFIC QUERIES Bonny Steensel, van
- Sponsor/Initiator University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD25-mei-2011 - 5-jun-2011


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