Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)
NCT ID: NCT01190917
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2009-09-30
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Behavioral Therapy Group
Cognitive Behavioral Therapy (CBT)
The CBT social skills curriculum is manualized and anchored in CBT strategies, such as problem identification, affective education, performance feedback, and weekly homework activities to facilitate generalization. The curriculum is a compilation of lessons targeting key social deficits in children with ASD, such as nonverbal communication, emotion recognition, and theory of mind. Structured teaching includes defining skills, breaking them down into simple, concrete steps, modeling the skill through role-play, and introducing a game or activity to practice the target skill. The approach to the parent group will be psychoeducational with a focus on reviewing target skills, rationale for teaching target skills, homework, progress or obstacles, and identifying strategies to promote generalization. Parent information handouts will be provided.
Social Play Group
Play Therapy
The social play group is manualized, led by a trained clinician and support staff, follows a specific routine, and contains a parent group component. Group leaders will follow participants' interests and suggestions for games. Group leaders utilize strategies such as reflective functioning statements on the child's behaviors to build emotion-focused play skills. The therapeutic setting incorporates play designed to encourage emotion-focused play including make-believe (dolls, houses), sensory (e.g. play-doh), and cooperative play (e.g. board games) toys. The approach to the parent group will be supportive rather than psychoeducational. Parents will set the agenda for discussion, facilitated by the group leader.
Interventions
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Cognitive Behavioral Therapy (CBT)
The CBT social skills curriculum is manualized and anchored in CBT strategies, such as problem identification, affective education, performance feedback, and weekly homework activities to facilitate generalization. The curriculum is a compilation of lessons targeting key social deficits in children with ASD, such as nonverbal communication, emotion recognition, and theory of mind. Structured teaching includes defining skills, breaking them down into simple, concrete steps, modeling the skill through role-play, and introducing a game or activity to practice the target skill. The approach to the parent group will be psychoeducational with a focus on reviewing target skills, rationale for teaching target skills, homework, progress or obstacles, and identifying strategies to promote generalization. Parent information handouts will be provided.
Play Therapy
The social play group is manualized, led by a trained clinician and support staff, follows a specific routine, and contains a parent group component. Group leaders will follow participants' interests and suggestions for games. Group leaders utilize strategies such as reflective functioning statements on the child's behaviors to build emotion-focused play skills. The therapeutic setting incorporates play designed to encourage emotion-focused play including make-believe (dolls, houses), sensory (e.g. play-doh), and cooperative play (e.g. board games) toys. The approach to the parent group will be supportive rather than psychoeducational. Parents will set the agenda for discussion, facilitated by the group leader.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
11 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Ting Wang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Latha Soorya, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai School of Medicine - Seaver Autism Center
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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GCO #09-0859
Identifier Type: -
Identifier Source: org_study_id