CBT for Anxiety Disorder in Children With Co-morbid ASD

Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder

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.

Study Overview

• Status: Completed
• Conditions: Randomized Treatment Study
• Intervention / Treatment: Behavioral: CBT

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Of Midtjylland
    • Risskov, Region Of Midtjylland, Denmark, 8240
      • Centre for Child and Adolescent Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASD
• Anxiety (not necessary diagnosed)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT	Behavioral: CBT; The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).; Other Names: Cool Kids ASD
No Intervention: WL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).	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.	Change from baseline interview results at 14 weeks
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).	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.	Change from baseline interview results at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spence Children's Anxiety Scale (SCAS),	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.	Change from baseline results at 14 weeks
Spence Children's Anxiety Scale (SCAS),	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.	Change from baseline results at 3 months
Children's Anxiety Life Inference Scale (CALIS)	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.	Change from baseline results at 14 weeks
Children's Anxiety Life Inference Scale (CALIS)	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.	Change from baseline results at 3 months
Children's Automatic Thoughts Scale (CATS).	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.	Change from baseline results at 14 weeks
Children's Automatic Thoughts Scale (CATS).	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.	Change from baseline results at 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)	Change from baseline results at 14 weeks
Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)	Change from baseline results at 3 months
Social Responsiveness Scale (SRS)	Change from baseline results at 14 weeks
Social Responsiveness Scale (SRS)	Change from baseline results at 3 months
Strength and Difficulties Questionnaire (SDQ)	Change from baseline results at 14 weeks
Strength and Difficulties Questionnaire (SDQ)	Change from baseline results at 3 months
The WHO-five Well-being Index (WHO-5)	Change from baseline results at 14 weeks
The WHO-five Well-being Index (WHO-5)	Change from baseline results at 3 months
Adaptive Behaviour Assessment System, Second Edition (ABAS-II)	Change from baseline results at 14 weeks
Adaptive Behaviour Assessment System, Second Edition (ABAS-II)	Change from baseline results at 3 months

Collaborators and Investigators

• Sponsor: University of Aarhus

Publications and helpful links

General Publications

• Kilburn TR, Sorensen MJ, Thastum M, Rapee RM, Rask CU, Arendt KB, Thomsen PH. Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial. Trials. 2018 Apr 2;19(1):210. doi: 10.1186/s13063-018-2591-x.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2016-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be on group basis only