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

Not Applicable

• Conditions: Intellectual Disability; Autism
• Interventions: Behavioral: Cognitive-Behavioral Therapy; Other: Functional magnetic resonance imaging (fMRI)

• Registration Number: NCT02914951
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Children with ASD share common symptoms in the core domains of social reciprocity, communication, and repetitive behaviors. In addition to the core symptoms, 50 to 70 percent of children with ASD often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, aggression and self-injury.

In this open pilot study expands clinical research on CBT for irritability to children with autism and mild cognitive impairment. CBT consists of individual weekly sessions dedicated to teaching children to recognize situations that may lead to frustration and to build coping skills for dealing with frustration in socially appropriate ways. Recent research as well as clinical reports suggest that children with mild intellectual disabilities (IQ between 55 and 85) can also benefit from CBT. The intervention is modified to reduce complexity of activities during therapy sessions but retains key elements and principles of CBT. Thus, the modified version of CBT is referred to as "Principles-Based Cognitive Behavior Therapy for Irritability in Autism" or PB-CBT for short. Subjects in this study will receive a comprehensive evaluation of ASD and associated psychopathology. Irritability and related disruptive behaviors will be rated on weekly basis to utilize a single-subject approach to data analysis. Children will be asked to participate in functional magnetic resonance imaging (fMRI) with tasks of social perception and emotion regulation before and after CBT. The purpose of the fMRI portion of the study is to evaluate feasibility of fMRI as an outcome measure in studies of behavioral interventions for children with ASD and intellectual disability.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2016-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

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Exclusion Criteria

• Medical or psychiatric condition that would require alternative treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy	Cognitive-Behavioral Therapy	CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.
Cognitive-Behavioral Therapy	Functional magnetic resonance imaging (fMRI)	CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist - Irritability Scale (ABC-I)	Weekly - up to 20 weeks	The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.
Modified Overt Aggression Scale (MOAS)	Weekly - up to 20 weeks	Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior

Secondary Outcome Measures

Name	Time	Method
Home Situations Questionnaire (HSQ)	endpoint (16 weeks)	HSQ is a parent-rated measure of noncompliance in children with ASD

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States