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Adolescent Social Skills Training Program (ASST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01031823
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Murray, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE December 12, 2009
First Posted Date  ICMJE December 15, 2009
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE November 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
Social Fluency [ Time Frame: 12 week, 3 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2009)
Social Fluency/Functioning [ Time Frame: 12 week, 3 month, 6 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
  • Loneliness Scale (Asher & Wheeler, 1985) [ Time Frame: 12 week, 3 month ]
  • Social Responsiveness Scale (SRS; Constantino, 2002) [ Time Frame: 12 week, 3 month ]
  • Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) [ Time Frame: 12 week, 3 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2009)
  • Clinical Global Impressions Scale (CGI; Guy, 1976) [ Time Frame: 12 week, 3 month, 6 month ]
  • Loneliness Scale (Asher & Wheeler, 1985) [ Time Frame: 12 week, 3 month, 6 month ]
  • Social Responsiveness Scale (SRS; Constantino, 2002) [ Time Frame: 12 week, 3 month, 6 month ]
  • Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) [ Time Frame: 12 week, 3 month, 6 month ]
  • Standardized Joint Attention Assessment [ Time Frame: 12 week, 3 month, 6 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adolescent Social Skills Training Program
Official Title  ICMJE The Multi-media Social Skills Project: Validation of an Intervention for Adolescents With Autism Spectrum Disorders
Brief Summary This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. 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 one follow-up session where the paper and pencil and video measures will be completed again.
Detailed Description

After consent , has been obtained, parents will complete the Autism Disorders Interview-Revised (ADI-R; Rutter & LeCourteur, 1995) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes & Calhoun, 1999), the Social Responsiveness Scale (SRS; Constantino, 2002), and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) at the initial appointment with the study coordinator.

After assent has been obtained, adolescents will complete the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman & Kaufman, 1990) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes & Calhoun, 1999), the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the Loneliness Scale (Asher & Wheeler, 1985). Adolescents will also complete a standardized joint attention assessment.

After the completion of the eligibility and pre-test interventions there will be a wash of participants who do not meet eligibility requirements.

One week before the start of the program, participants will attend an introduction session to the program. At this time, participants will be filmed in a brief interaction with a typically developing peer that will be used as a baseline indicator of their social fluency.

Participants will attend the social skills intervention program once a week for twelve weeks. Each week there will be approximately 90 minutes of group therapy which will be conducted like a seminar class: the principal investigator will teach and review social interaction skills and nuances, participants will be encouraged to take an active role in the class.

During the twelve week intervention there will be three review/fluency building sessions: week four, week eight, and week twelve. The group therapy sessions for these review weeks will simply review the material that was covered during the prior three weeks. Participants will then practice what they have learned by having a conversation with a peer that will be taped.

Following the group therapy session each week, participants will join six typically developing peers in a 90 minute introductory photography class taught by one of the study's co-investigators. The photography class will give the participants the opportunity to practice the skills learned in group therapy with their peer group.

Participants will once again complete a battery of clinical and self-report outcome measures which will serve as the post-test measurements for the study. They will be filmed in a brief interaction with a typically developing peer which will be coded to obtain post-test social interaction skills and fluency scores. These evaluations will occur at completion of social skills program, and at three month follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asperger's Disorder
  • High-functioning Autism
Intervention  ICMJE Behavioral: Multi-Media Social Skills Training Program
All individuals will participate in a twelve week social skills training program designed to enhance the social skills of adolescents with Asperger's Disorder or high-functioning autism. The intervention is comprised of both group therapy and peer generalization.
Study Arms  ICMJE Experimental: Social Skills Training
All participants will take part in this arm of the study.
Intervention: Behavioral: Multi-Media Social Skills Training Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2009)
24
Actual Study Completion Date  ICMJE July 10, 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 13 and 17 years of age
  • A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Autism Disorders Interview-Revised (ADIR; Rutter & LeCourteur, 1995)
  • An IQ of 70 or above on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman & Kaufman, 1990)
  • Local to Central Pennsylvania region

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01031823
Other Study ID Numbers  ICMJE 32300
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Murray, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Micheal J Murray, M.D. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP