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ENROLLING BY INVITATION
NCT02914951
NA

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

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

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.

Official title: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (An Open Pilot Study in Autism Spectrum Disorder)

Key Details

Gender

All

Age Range

8 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2016-10

Completion Date

2026-12

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive-Behavioral Therapy

CBT is a behavioral intervention that consists of 12 60- to 90-minute-long weekly sessions. A modified, principles-based form of CBT will be used in this study to reduce complexity of activities during therapy sessions while retaining all key elements and principles of CBT.

OTHER

Functional magnetic resonance imaging (fMRI)

Functional magnetic resonance imaging (fMRI). There will be two fMRI visits, 60 to 90 minute each, one before and the other after CBT. fMRI is a technique that uses magnetism to measure activity of the brain as participants perform simple tasks such as pressing the button in response to pictures. During this study, children will be asked to look at pictures of objects and press or not press the button in response to specific instruction. Participants will also look at pictures of faces and light-point displays depicted biological motion. fMRI is used as an outcome measure to explore if change in irritability is associated with change in brain responses to these tasks during fMRI.

Locations (1)

Yale Child Study Center

New Haven, Connecticut, United States