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Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)

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Mount Sinai Health System

Status

Completed

Conditions

Autism Spectrum Disorder
Autism

Treatments

Behavioral: Play Therapy
Behavioral: Cognitive Behavioral Therapy (CBT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01190917
GCO #09-0859
R21MH089236 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to compare two different treatment approaches to social skills groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will examine changes in both behavior and the brain following treatment.

Full description

Despite the fact that social skills impairments are the most persistent and pervasive symptoms affecting individuals with ASD, treatments targeting social skills have been the subject of few controlled investigations. The available literature suggests that cognitive behavioral techniques are commonly used and may improve targeted social skills in individuals with ASD. However, drawing firm conclusions about the efficacy of social skills treatment remains difficult, particularly with respect to maintenance of skills and generalization to natural settings, owing to methodological limitations of extant studies (e.g., small sample size, lack of manual-based curricula, minimal assessment of generalization or maintenance).

Several neuroimaging studies have found that individuals with ASD underactivate key brain regions involved in social cognition. However, there is also evidence to suggest that factors that increase attention to or interest in social stimuli are associated with more normal brain activity.

The purpose of this investigation is to examine the acute and sustained effects of social skills treatment on social cognition and the neural architecture that supports it. High-functioning children with ASD will be randomly assigned to a 12-week cognitive behavioral social skills group or a social play-based therapy group. For both types of groups, a parent session will be held concurrently. Functional MRI scans as well as behavioral assessments of social cognition, adaptive functioning, and symptom severity will be acquired at baseline, immediately following treatment, and at a 3-month follow-up.

Enrollment

50 patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 8 to 11 years of age
  • Meets criteria for ASD according to psychiatric interview (DSM-IV), the Autism Diagnostic Observation Schedule-Generic, and the Autism Diagnostic Interview-Revised
  • Verbal IQ ≥ 70, as measured by the Wechsler Intelligence Scale for Children-Fourth Edition or Wechsler Abbreviated Scale of Intelligence

Exclusion criteria

  • History of psychiatric or neurological disorders other than ASD (e.g., schizophrenia, depression, seizure disorder)
  • Within 30 days prior to the initial evaluation, beginning any new psychotropic medication or other therapeutic intervention (e.g., behavior, speech, physical/occupational, cognitive, nutritional therapy) that would confound the evaluation of the social skills groups
  • Gross structural abnormality present in the brain (e.g., aneurysm)
  • History of head trauma or loss of consciousness
  • For any reason the child or parents appear unable to participate in study procedures

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Cognitive Behavioral Therapy Group
Active Comparator group
Treatment:
Behavioral: Cognitive Behavioral Therapy (CBT)
Social Play Group
Active Comparator group
Treatment:
Behavioral: Play Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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