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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836965
• Other study ID #: 42565EP
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 9, 2018

Study information

• Verified date: March 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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

Locations

Country	Name	City	State
United States	Penn State Hershey Psychiatry Clinic	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up		3 Month Follow Up
Secondary	Change from Baseline Loneliness Scale at 3-month Follow Up		3 Month Follow Up
Secondary	Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up		3 Month Follow Up
Secondary	Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up		3 Month Follow Up