CBT for Anxiety Disorder in Children With Co-morbid ASD

NCT02908321 | Completed

• 1 other identifier: 2016-2018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Randomized Treatment Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Spence Children's Anxiety Scale (SCAS),

  Change from baseline results at 14 weeks

• Spence Children's Anxiety Scale (SCAS),

  Change from baseline results at 3 months

• Children's Anxiety Life Inference Scale (CALIS)

  Change from baseline results at 14 weeks

• Children's Anxiety Life Inference Scale (CALIS)

  Change from baseline results at 3 months

• Children's Automatic Thoughts Scale (CATS).

  Change from baseline results at 14 weeks

Other Outcomes (10)

• 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

Study Arms (2)

CBT

ACTIVE COMPARATOR

Behavioral: CBT

WL

NO INTERVENTION

Interventions

CBT BEHAVIORAL

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

Also known as: Cool Kids ASD

CBT

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASD
• Anxiety (not necessary diagnosed)

You may not qualify if:

• IQ under 70
• Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS
• Active psychosis
• Untreated ADHD
• Families not able to follow program

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Centre for Child and Adolescent Psychiatry

Risskov, Region of Midtjylland, 8240, Denmark

Location

Related Publications (1)

• 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.

  PMID: 29609630 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 10, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)