Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Autism
  • Intellectual Disability
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disabilityMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 8 years and 16 years
Gender
Both males and females

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 a...

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.

Tracking Information

NCT #
NCT02914951
Collaborators
Not Provided
Investigators
Principal Investigator: Denis Sukhodolsky, PhD Associate Professor