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CBT for Anxiety Disorder in Children With Co-morbid ASD

Primary Purpose

Randomized Treatment Study

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CBT
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Randomized Treatment Study

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Child and Adolescent Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CBT

WL

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 7, 2016
Last Updated
November 6, 2020
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02908321
Brief Title
CBT for Anxiety Disorder in Children With Co-morbid ASD
Official Title
Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomized Treatment Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Active Comparator
Arm Title
WL
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cool Kids ASD
Intervention Description
The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).
Description
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.
Time Frame
Change from baseline interview results at 14 weeks
Title
Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).
Description
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.
Time Frame
Change from baseline interview results at 3 months
Secondary Outcome Measure Information:
Title
Spence Children's Anxiety Scale (SCAS),
Description
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.
Time Frame
Change from baseline results at 14 weeks
Title
Spence Children's Anxiety Scale (SCAS),
Description
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.
Time Frame
Change from baseline results at 3 months
Title
Children's Anxiety Life Inference Scale (CALIS)
Description
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.
Time Frame
Change from baseline results at 14 weeks
Title
Children's Anxiety Life Inference Scale (CALIS)
Description
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.
Time Frame
Change from baseline results at 3 months
Title
Children's Automatic Thoughts Scale (CATS).
Description
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.
Time Frame
Change from baseline results at 14 weeks
Title
Children's Automatic Thoughts Scale (CATS).
Description
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.
Time Frame
Change from baseline results at 3 months
Other Pre-specified Outcome Measures:
Title
Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)
Time Frame
Change from baseline results at 14 weeks
Title
Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)
Time Frame
Change from baseline results at 3 months
Title
Social Responsiveness Scale (SRS)
Time Frame
Change from baseline results at 14 weeks
Title
Social Responsiveness Scale (SRS)
Time Frame
Change from baseline results at 3 months
Title
Strength and Difficulties Questionnaire (SDQ)
Time Frame
Change from baseline results at 14 weeks
Title
Strength and Difficulties Questionnaire (SDQ)
Time Frame
Change from baseline results at 3 months
Title
The WHO-five Well-being Index (WHO-5)
Time Frame
Change from baseline results at 14 weeks
Title
The WHO-five Well-being Index (WHO-5)
Time Frame
Change from baseline results at 3 months
Title
Adaptive Behaviour Assessment System, Second Edition (ABAS-II)
Time Frame
Change from baseline results at 14 weeks
Title
Adaptive Behaviour Assessment System, Second Edition (ABAS-II)
Time Frame
Change from baseline results at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre for Child and Adolescent Psychiatry
City
Risskov
State/Province
Region Of Midtjylland
ZIP/Postal Code
8240
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be on group basis only
Citations:
PubMed Identifier
29609630
Citation
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.
Results Reference
derived

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CBT for Anxiety Disorder in Children With Co-morbid ASD

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