CBT for Anxiety Disorder in Children With Co-morbid ASD

Not Applicable

Completed

• Conditions: Randomized Treatment Study
• Interventions: Behavioral: CBT

• Registration Number: NCT02908321
• Lead Sponsor: University of Aarhus

Brief Summary

Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.

Detailed Description

The primary objective is to investigate the effect of a manualised Cognitive Behavioural Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD) in a waitlist controlled design.

The investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. Further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD), hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative skills).

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Status Verified: 2019-04
• Primary Completion: 2019-09
• Study Completion: 2019-12
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• ASD
• Anxiety (not necessary diagnosed)

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Exclusion Criteria

• IQ under 70
• Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS
• Active psychosis
• Untreated ADHD
• Families not able to follow program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	CBT	-

Primary Outcome Measures

Name	Time	Method
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).	Change from baseline interview results at 3 months	ADIS/CP is a structured interview involving both child and parents designed to assess for current episodes of anxiety disorders, and to permit differential diagnosis among the anxiety disorders according to DSM-IV criteria.

Secondary Outcome Measures

Name	Time	Method
Children's Automatic Thoughts Scale (CATS).	Change from baseline results at 3 months	CATS is a developmentally sensitive, general measure of negative self-statements across both internalizing and externalizing problems. Four separate subscales of cognitive content are assessed including physical threat, social threat, personal failure, and hostility.
Spence Children's Anxiety Scale (SCAS),	Change from baseline results at 3 months	SCAS is a questionnaire for children and parents assessing the severity of anxiety symptoms broadly in line with the dimensions of anxiety disorder proposed by the DSM-IV. The scale assesses six domains of anxiety including generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive-compulsive disorder and physical injury fears.
Children's Anxiety Life Inference Scale (CALIS)	Change from baseline results at 3 months	CALIS is designed to assess life interference attributed to fears and worries from child and parent perspectives. The measure targets interference on the child's life and on the parent's/family's life.

Trial Locations

Locations (1)

Centre for Child and Adolescent Psychiatry; 🇩🇰 Risskov, Region Of Midtjylland, Denmark