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

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01836965

Collaborator

(none)

155

Enrollment

Location

Arm

61.3

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorders	Behavioral: Social Skills Intervention	N/A

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

Actual Enrollment :

155 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Apr 9, 2018

Actual Study Completion Date :

Apr 9, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention [One Week Post-Intervention]
The SDQ is a 25 item survey that asks about positive and negative attributes.
Change from Baseline Loneliness Scale after Intervention [One Week Post 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 [One Week Post-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 [One Week Post-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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

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