CBT for Anxiety Disorder in Children With Co-morbid ASD

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT02908321
Collaborator
(none)
49
1
2
40
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBT
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). [Change from baseline interview results at 14 weeks]

      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.

    2. 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

    1. Spence Children's Anxiety Scale (SCAS), [Change from baseline results at 14 weeks]

      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.

    2. 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.

    3. Children's Anxiety Life Inference Scale (CALIS) [Change from baseline results at 14 weeks]

      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.

    4. 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.

    5. Children's Automatic Thoughts Scale (CATS). [Change from baseline results at 14 weeks]

      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.

    6. 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.

    Other Outcome Measures

    1. Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS) [Change from baseline results at 14 weeks]

    2. Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS) [Change from baseline results at 3 months]

    3. Social Responsiveness Scale (SRS) [Change from baseline results at 14 weeks]

    4. Social Responsiveness Scale (SRS) [Change from baseline results at 3 months]

    5. Strength and Difficulties Questionnaire (SDQ) [Change from baseline results at 14 weeks]

    6. Strength and Difficulties Questionnaire (SDQ) [Change from baseline results at 3 months]

    7. The WHO-five Well-being Index (WHO-5) [Change from baseline results at 14 weeks]

    8. The WHO-five Well-being Index (WHO-5) [Change from baseline results at 3 months]

    9. Adaptive Behaviour Assessment System, Second Edition (ABAS-II) [Change from baseline results at 14 weeks]

    10. Adaptive Behaviour Assessment System, Second Edition (ABAS-II) [Change from baseline results at 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Child and Adolescent Psychiatry Risskov Region Of Midtjylland Denmark 8240

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT02908321
    Other Study ID Numbers:
    • 2016-2018
    First Posted:
    Sep 20, 2016
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2020