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

NCT02914951 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Autism
  • Intellectual Disability

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Denis Sukhodolsky, PhD · Associate Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914951 on ClinicalTrials.gov