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Enrolling by Invitation

NCT Number: NCT02914951

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

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.

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Key information

Conditions

Autism Aberrant Motor Behavior in Dementia Aggression Autism Spectrum Disorder Autistic Disorder Behavior Behavioral Symptoms Child Behavior Child Development Disorders, Pervasive Cognition Disorders Cognitive Dysfunction Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Problem Behavior Signs and Symptoms Social Behavior

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Modified Overt Aggression Scale (MOAS)

    Time frame: 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

  2. Aberrant Behavior Checklist - Irritability Scale (ABC-I)

    Time frame: 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.

Secondary outcomes

  1. Home Situations Questionnaire (HSQ)

    Time frame: baseline

    HSQ is a parent-rated measure of noncompliance in children with ASD

  2. Home Situations Questionnaire (HSQ)

    Time frame: endpoint (16 weeks)

    HSQ is a parent-rated measure of noncompliance in children with ASD

Other outcomes

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

    Time frame: baseline

    Participants will perform an emotion-induction GoNoGo task during fMRI

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

    Time frame: endpoint (16 weeks)

    Participants will perform an emotion-induction GoNoGo task during fMRI

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

    Time frame: baseline

    Children will perform a task of emotional face perception during fMRI

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

    Time frame: endpoint (16 weeks)

    Children will perform a task of emotional face perception during fMRI

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2016
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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