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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael Murray, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01836965
First received: March 28, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 60 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 measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.


Condition Intervention
Autism Spectrum Disorders
Behavioral: Social Skills Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change from Baseline Social Responsiveness Scale Score after Intervention [ Time Frame: One Week Post-Intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention [ Time Frame: One Week Post-Intervention ] [ Designated as safety issue: No ]
    The SDQ is a 25 item survey that asks about positive and negative attributes.

  • Change from Baseline Loneliness Scale after Intervention [ Time Frame: One Week Post Intervention ] [ Designated as safety issue: No ]
    The Loneliness Scale is a 24-item survey that assesses social and emotional loneliness.

  • Change from Baseline Multidimensional Anxiety Scale for Children after Intervention [ Time Frame: One Week Post-Intervention ] [ Designated as safety issue: No ]
    The MASC is a 39-item survey that assesses anxiety symptoms in children.

  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention [ Time Frame: One Week Post-Intervention ] [ Designated as safety issue: No ]
    The Strengths and Difficulties Questionnaire is a 25 item survey that asks about positive and negative attributes.

  • Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]
  • Change from Baseline Loneliness Scale at 3-month Follow Up [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]
  • Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]
  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up [ Time Frame: 3 Month Follow Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Skills Intervention
The intervention is a 12-week social skills training program that will consist of a 75 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.
Behavioral: Social Skills Intervention
Twelve week manual based social skills curriculum targeting social fluency and responsiveness.

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 120 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 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 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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 13 and 17 years of age
  • A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
  • An Intelligence Quotient of 70 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836965

Contacts
Contact: Lindsay M Milliken, BA 717-531-0003 ext 286286 lmilliken@hmc.psu.edu
Contact: Krina Durica, BS 717-531-0003 ext 286286 kdurica@hmc.psu.edu

Locations
United States, Pennsylvania
The Vista School Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Michael Murray, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Michael Murray, MD Penn State College of Medicine
  More Information

No publications provided

Responsible Party: Michael Murray, MD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01836965     History of Changes
Other Study ID Numbers: 42565EP
Study First Received: March 28, 2013
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Aspergers
Social Skills
Adolescents
High-functioning Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014