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

NCT02914951 | Enrolling By Invitation

• 2 other identifiers: 0102012121-DNo NIH funding
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Intellectual Disability

Keywords

Autism; Irritability; Disruptive Behavior; Aggression; Behavior Therapy; Cognitive Behavioral Therapy; Intellectual Disability; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Home Situations Questionnaire (HSQ)

  baseline

• Home Situations Questionnaire (HSQ)

  endpoint (16 weeks)

Other Outcomes (4)

• BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan

  baseline

• BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan

  endpoint (16 weeks)

• BOLD signal change during the emotional face perception task completed during fMRI scan

  baseline

Study Arms (1)

Cognitive-Behavioral Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-Behavioral Therapy; Other: Functional magnetic resonance imaging (fMRI)

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

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.

Cognitive-Behavioral Therapy

Functional magnetic resonance imaging (fMRI) OTHER

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.

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related 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.

  PMID: 26745682 RESULT

• 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 for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):38-48. doi: 10.1089/cap.2015.0164. Epub 2016 Jan 19.

  PMID: 26784537 RESULT

Related Links

• Behavior therapy studies for children with autism spectrum disorder at Sukhodolsky lab

MeSH Terms

Conditions

Autistic Disorder; Intellectual Disability; Problem Behavior; Aggression; Cognitive Dysfunction

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Denis Sukhodolsky, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disability

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)