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



Status:Suspended
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:8 - 16
Updated:4/17/2018
Start Date:October 2016
End Date:December 2018

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

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.

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.

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
We found this trial at
1
site
New Haven, Connecticut 06520
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from
New Haven, CT
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