Clinical trial NCT01836965: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Aspergers
Social Skills
Adolescents
High-functioning Autism
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 155
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Social Responsiveness Scale Score after Intervention
timeFrame: One Week Post-Intervention
measure: Video recording of Social Interaction
timeFrame: One Week Post-Intervention
Secondary outcomes:
measure: Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention
timeFrame: One Week Post-Intervention
measure: Change from Baseline Loneliness Scale after Intervention
timeFrame: One Week Post Intervention
measure: Change from Baseline Multidimensional Anxiety Scale for Children after Intervention
timeFrame: One Week Post-Intervention
measure: Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention
timeFrame: One Week Post-Intervention
measure: Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up
timeFrame: 3 Month Follow Up
measure: Change from Baseline Loneliness Scale at 3-month Follow Up
timeFrame: 3 Month Follow Up
measure: Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up
timeFrame: 3 Month Follow Up
measure: Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up
timeFrame: 3 Month Follow Up
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Psychiatry Clinic
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Michael Murray, MD
role: PRINCIPAL_INVESTIGATOR
References: