Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability

Enrolling by invitation · Not applicable

Conditions studied: Autism, Intellectual Disability

In brief

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

Key facts

Study ID

NCT02914951

Run by

Yale University

People needed

6

Starts

2016-10-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 8 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-5 diagnosis of Autism Spectrum Disorder
• Presence of disruptive behaviors such as irritability and anger outbursts
• IQ between 55 and 85
• ABC Irritability Scale score greater than or equal to 15
• Un-medicated or on stable medication regimen
• Able to complete all study assessment and fMRI procedures

You may not qualify if…

• Medical or psychiatric condition that would require alternative treatment

Where it is running

• Yale Child Study Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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