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

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Skills Intervention
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Aspergers, Social Skills, Adolescents, High-functioning Autism

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Hershey Psychiatry Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Social Skills Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline Social Responsiveness Scale Score after Intervention
The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2013
Last Updated
March 11, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01836965
Brief Title
Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders
Official Title
Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Aspergers, Social Skills, Adolescents, High-functioning Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Skills Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Social Skills Intervention
Intervention Description
Twelve week manual based social skills curriculum targeting social fluency and responsiveness.
Primary Outcome Measure Information:
Title
Change from Baseline Social Responsiveness Scale Score after Intervention
Description
The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.
Time Frame
One Week Post-Intervention
Title
Video recording of Social Interaction
Description
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.
Time Frame
One Week Post-Intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention
Description
The SDQ is a 25 item survey that asks about positive and negative attributes.
Time Frame
One Week Post-Intervention
Title
Change from Baseline Loneliness Scale after Intervention
Description
The Loneliness Scale is a 24-item survey that assesses social and emotional loneliness.
Time Frame
One Week Post Intervention
Title
Change from Baseline Multidimensional Anxiety Scale for Children after Intervention
Description
The MASC is a 39-item survey that assesses anxiety symptoms in children.
Time Frame
One Week Post-Intervention
Title
Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention
Description
The Strengths and Difficulties Questionnaire is a 25 item survey that asks about positive and negative attributes.
Time Frame
One Week Post-Intervention
Title
Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up
Time Frame
3 Month Follow Up
Title
Change from Baseline Loneliness Scale at 3-month Follow Up
Time Frame
3 Month Follow Up
Title
Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up
Time Frame
3 Month Follow Up
Title
Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up
Time Frame
3 Month Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Murray, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Psychiatry Clinic
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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