Clinical trial NCT01190917: Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)
Official title: Acute and Sustained Effects of Social Skills Intervention on Neural and Behavioral Outcomes in Children With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: Autism
Autism Spectrum Disorder
Disorder
Autistic
Asperger Syndrome
social skills group
behavioral intervention
Imaging, Magnetic Resonance
fMRI
Functional MRI
MRI, Functional
Magnetic Resonance Imaging
Functional
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
timeFrame: Week 0
measure: Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
timeFrame: Week 12
measure: Diagnostic Analysis of Nonverbal Accuracy-2* (DANVA2)
timeFrame: Week 24
measure: Reading the Mind in the Eyes Task - Child Version
timeFrame: Week 0
measure: Reading the Mind in the Eyes Task - Child Version
timeFrame: Week 12
measure: Reading the Mind in the Eyes Task - Child Version
timeFrame: Week 24
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Week 0
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Week 12
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Week 24
Secondary outcomes:
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 0
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 12
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 24
measure: Strange Stories Task
timeFrame: Week 0
measure: Strange Stories Task
timeFrame: Week 12
measure: Strange Stories Task
timeFrame: Week 24
measure: Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
timeFrame: Week 0
measure: Vineland Adaptive Behavior Scales, Second Edition (Vineland II)
timeFrame: Week 12
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: Week 0
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: Week 12
measure: Direct Observation
timeFrame: 12 weeks (during treatment sessions)
measure: Peer generalization assessment
timeFrame: Week 0
measure: Peer generalization assessment
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine - Seaver Autism Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ting Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Latha Soorya, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soorya LV, Siper PM, Beck T, Soffes S, Halpern D, Gorenstein M, Kolevzon A, Buxbaum J, Wang AT. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):208-216.e1. doi: 10.1016/j.jaac.2014.12.005. Epub 2014 Dec 20.