Clinical trial NCT02914951: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism
Intellectual Disability
Keywords: Autism
Irritability
Disruptive Behavior
Aggression
Behavior Therapy
Cognitive Behavioral Therapy
Intellectual Disability
Cognitive Impairment
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disability
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: Weekly - up to 20 weeks
measure: Aberrant Behavior Checklist - Irritability Scale (ABC-I)
timeFrame: Weekly - up to 20 weeks
Secondary outcomes:
measure: Home Situations Questionnaire (HSQ)
timeFrame: baseline
measure: Home Situations Questionnaire (HSQ)
timeFrame: endpoint (16 weeks)
Other outcomes:
measure: BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan
timeFrame: baseline
measure: BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan
timeFrame: endpoint (16 weeks)
measure: BOLD signal change during the emotional face perception task completed during fMRI scan
timeFrame: baseline
measure: BOLD signal change during the emotional face perception task completed during fMRI scan
timeFrame: endpoint (16 weeks)
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Associate Professor
name: Denis Sukhodolsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.