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

Primary Purpose

Autism, Intellectual Disability

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Functional magnetic resonance imaging (fMRI)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy, Intellectual Disability, Cognitive Impairment

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive-Behavioral Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Home Situations Questionnaire (HSQ)
HSQ is a parent-rated measure of noncompliance in children with ASD
Home Situations Questionnaire (HSQ)
HSQ is a parent-rated measure of noncompliance in children with ASD

Full Information

First Posted
September 20, 2016
Last Updated
February 24, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02914951
Brief Title
Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability
Official Title
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (An Open Pilot Study in Autism Spectrum Disorder)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Intellectual Disability
Keywords
Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy, Intellectual Disability, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disability
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional magnetic resonance imaging (fMRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Overt Aggression Scale (MOAS)
Description
Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior
Time Frame
Weekly - up to 20 weeks
Title
Aberrant Behavior Checklist - Irritability Scale (ABC-I)
Description
The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.
Time Frame
Weekly - up to 20 weeks
Secondary Outcome Measure Information:
Title
Home Situations Questionnaire (HSQ)
Description
HSQ is a parent-rated measure of noncompliance in children with ASD
Time Frame
baseline
Title
Home Situations Questionnaire (HSQ)
Description
HSQ is a parent-rated measure of noncompliance in children with ASD
Time Frame
endpoint (16 weeks)
Other Pre-specified Outcome Measures:
Title
BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan
Description
Participants will perform an emotion-induction GoNoGo task during fMRI
Time Frame
baseline
Title
BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan
Description
Participants will perform an emotion-induction GoNoGo task during fMRI
Time Frame
endpoint (16 weeks)
Title
BOLD signal change during the emotional face perception task completed during fMRI scan
Description
Children will perform a task of emotional face perception during fMRI
Time Frame
baseline
Title
BOLD signal change during the emotional face perception task completed during fMRI scan
Description
Children will perform a task of emotional face perception during fMRI
Time Frame
endpoint (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Sukhodolsky, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26745682
Citation
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.
Results Reference
result
PubMed Identifier
26784537
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 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.
Results Reference
result

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

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