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Completed

NCT Number: NCT02908321

CBT for Anxiety Disorder in Children With Co-morbid ASD

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.

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Key information

Conditions

Randomized Treatment Study

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Child and Adolescent Psychiatry

Risskov, Region of Midtjylland, 8240, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

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

Primary outcomes

  1. Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).

    Time frame: 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).

    Time frame: 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 outcomes

  1. Spence Children's Anxiety Scale (SCAS),

    Time frame: 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),

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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).

    Time frame: 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 outcomes

  1. Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)

    Time frame: Change from baseline results at 14 weeks

  2. Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)

    Time frame: Change from baseline results at 3 months

  3. Social Responsiveness Scale (SRS)

    Time frame: Change from baseline results at 14 weeks

  4. Social Responsiveness Scale (SRS)

    Time frame: Change from baseline results at 3 months

  5. Strength and Difficulties Questionnaire (SDQ)

    Time frame: Change from baseline results at 14 weeks

  6. Strength and Difficulties Questionnaire (SDQ)

    Time frame: Change from baseline results at 3 months

  7. The WHO-five Well-being Index (WHO-5)

    Time frame: Change from baseline results at 14 weeks

  8. The WHO-five Well-being Index (WHO-5)

    Time frame: Change from baseline results at 3 months

  9. Adaptive Behaviour Assessment System, Second Edition (ABAS-II)

    Time frame: Change from baseline results at 14 weeks

  10. Adaptive Behaviour Assessment System, Second Edition (ABAS-II)

    Time frame: Change from baseline results at 3 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2016
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.