Clinical trial NCT02908321: 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
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Treatment Study
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).
timeFrame: Change from baseline interview results at 14 weeks
measure: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP).
timeFrame: Change from baseline interview results at 3 months
Secondary outcomes:
measure: Spence Children's Anxiety Scale (SCAS),
timeFrame: Change from baseline results at 14 weeks
measure: Spence Children's Anxiety Scale (SCAS),
timeFrame: Change from baseline results at 3 months
measure: Children's Anxiety Life Inference Scale (CALIS)
timeFrame: Change from baseline results at 14 weeks
measure: Children's Anxiety Life Inference Scale (CALIS)
timeFrame: Change from baseline results at 3 months
measure: Children's Automatic Thoughts Scale (CATS).
timeFrame: Change from baseline results at 14 weeks
measure: Children's Automatic Thoughts Scale (CATS).
timeFrame: Change from baseline results at 3 months
Other outcomes:
measure: Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)
timeFrame: Change from baseline results at 14 weeks
measure: Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS)
timeFrame: Change from baseline results at 3 months
measure: Social Responsiveness Scale (SRS)
timeFrame: Change from baseline results at 14 weeks
measure: Social Responsiveness Scale (SRS)
timeFrame: Change from baseline results at 3 months
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: Change from baseline results at 14 weeks
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: Change from baseline results at 3 months
measure: The WHO-five Well-being Index (WHO-5)
timeFrame: Change from baseline results at 14 weeks
measure: The WHO-five Well-being Index (WHO-5)
timeFrame: Change from baseline results at 3 months
measure: Adaptive Behaviour Assessment System, Second Edition (ABAS-II)
timeFrame: Change from baseline results at 14 weeks
measure: Adaptive Behaviour Assessment System, Second Edition (ABAS-II)
timeFrame: Change from baseline results at 3 months
Locations:
city: Risskov
country: Denmark
facility: Centre for Child and Adolescent Psychiatry
state: Region Of Midtjylland
Study officials:
References:
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.