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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02914951
• Other study ID #: 0102012121-D
• Secondary ID: No NIH funding
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Exclusion Criteria:

• Medical or psychiatric condition that would require alternative treatment

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Intellectual Disability

Intervention

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

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sukhodolsky DG, Smith SD, McCauley SA, Ibrahim K, Piasecka JB. Behavioral Interventions for Anger, Irritability, and Aggression in Children and Adolescents. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):58-64. doi: 10.1089/cap.2015.0120. Epub 2016 Jan 8 — View Citation

Sukhodolsky DG, Vander Wyk BC, Eilbott JA, McCauley SA, Ibrahim K, Crowley MJ, Pelphrey KA. Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan	Participants will perform an emotion-induction GoNoGo task during fMRI	baseline
Other	BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan	Participants will perform an emotion-induction GoNoGo task during fMRI	endpoint (16 weeks)
Other	BOLD signal change during the emotional face perception task completed during fMRI scan	Children will perform a task of emotional face perception during fMRI	baseline
Other	BOLD signal change during the emotional face perception task completed during fMRI scan	Children will perform a task of emotional face perception during fMRI	endpoint (16 weeks)
Primary	Modified Overt Aggression Scale (MOAS)	Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior	Weekly - up to 20 weeks
Primary	Aberrant Behavior Checklist - Irritability Scale (ABC-I)	The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.	Weekly - up to 20 weeks
Secondary	Home Situations Questionnaire (HSQ)	HSQ is a parent-rated measure of noncompliance in children with ASD	baseline
Secondary	Home Situations Questionnaire (HSQ)	HSQ is a parent-rated measure of noncompliance in children with ASD	endpoint (16 weeks)