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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Behavioral: Social Skills Intervention

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 Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Psychiatry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Social Skills Intervention; 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.

Behavioral: Social Skills Intervention; Twelve week manual based social skills curriculum targeting social fluency and responsiveness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Social Responsiveness Scale Score after Intervention	The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.	One Week Post-Intervention
Video recording of Social Interaction	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.	One Week Post-Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention	The SDQ is a 25 item survey that asks about positive and negative attributes.	One Week Post-Intervention
Change from Baseline Loneliness Scale after Intervention	The Loneliness Scale is a 24-item survey that assesses social and emotional loneliness.	One Week Post Intervention
Change from Baseline Multidimensional Anxiety Scale for Children after Intervention	The MASC is a 39-item survey that assesses anxiety symptoms in children.	One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention	The Strengths and Difficulties Questionnaire is a 25 item survey that asks about positive and negative attributes.	One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire 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
Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up		3 Month Follow Up

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Michael Murray, MD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 22, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Social Skills; Aspergers; High-functioning Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 42565EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO