CBT for Anxiety Disorder in Children With Co-morbid ASD

Randomized Treatment Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908321
• Other study ID #: 2016-2018
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Randomized Treatment Study

Intervention

Behavioral:
• CBT
The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).

Locations

Country	Name	City	State
Denmark	Centre for Child and Adolescent Psychiatry	Risskov	Region Of Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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