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Clinical Trials/NCT01836965
NCT01836965CompletedNot Applicable

Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders

Milton S. Hershey Medical Center1 site in 1 country155 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
155
Locations
1
Primary Endpoint
Change from Baseline Social Responsiveness Scale Score after Intervention

Study Overview

Brief Summary

The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.

Detailed Description

This study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. Approximately 300 adolescents will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time sequential manner with up to four cohorts running at a time. Participants and their parents will complete pre-test measures including both paper and pencil, online, or phone measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil, online, or phone measures and video post-test measures. Participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Between 13 and 17 years of age
  • •Must be a Pennsylvania resident
  • •A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
  • •English as primary language spoken
  • •Ability to fluently speak in full sentences
  • •A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition(KBIT-2; Kaufman & Kaufman, 1990)

Exclusion Criteria

  • •A significant language delay
  • •Difficulty with aggression directed at peers
  • •A primary thought disorder
  • •A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
  • •Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals

Arms & Interventions

Social Skills Intervention

Experimental

The intervention is a 12-week social skills training program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session (in the form of a photography class with typically developing peers) meeting once per week. Each cohort will consist of 6 adolescents with Aspergers or high-functioning autism, who will be joined by 6 typically-developing peers for the photography class. During the group therapy session adolescents will discuss and watch video clips addressing social skills topics relevant to their age group. They will have a chance to practice these skills when paired with a typically developing peer for the photography class.

Intervention: Social Skills Intervention (Behavioral)

Outcomes

Primary Outcomes

Change from Baseline Social Responsiveness Scale Score after Intervention

Time Frame: One Week Post-Intervention

The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.

Video recording of Social Interaction

Time Frame: One Week Post-Intervention

Participants will be filmed in a brief interaction with a typically developing peer which will be coded to obtain social interaction skills and fluency scores.

Secondary Outcomes

  • Change from Baseline Multidimensional Anxiety Scale for Children after Intervention(One Week Post-Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up(3 Month Follow Up)
  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention(One Week Post-Intervention)
  • Change from Baseline Loneliness Scale after Intervention(One Week Post Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention(One Week Post-Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up(3 Month Follow Up)
  • Change from Baseline Loneliness Scale at 3-month Follow Up(3 Month Follow Up)
  • Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up(3 Month Follow Up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Murray

MD

Milton S. Hershey Medical Center

Study Sites (1)

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