Clinical trial NCT01031823: Adolescent Social Skills Training Program
Official title: The Multi-media Social Skills Project: Validation of an Intervention for Adolescents With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asperger's Disorder
High-functioning Autism
Keywords: Autism Spectrum Disorder
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 50
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: This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. Participants and their parents will complete pre-test measures including both paper and pencil 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 and video post-test measures. Participants will be encouraged to participate in one follow-up session where the paper and pencil and video measures will be completed again.

Detailed description: After consent , has been obtained, parents will complete the Autism Disorders Interview-Revised (ADI-R; Rutter \& LeCourteur, 1995) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Social Responsiveness Scale (SRS; Constantino, 2002), and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) at the initial appointment with the study coordinator.

After assent has been obtained, adolescents will complete the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the Loneliness Scale (Asher \& Wheeler, 1985). Adolescents will also complete a standardized joint attention assessment.

After the completion of the eligibility and pre-test interventions there will be a wash of participants who do not meet eligibility requirements.

One week before the start of the program, participants will attend an introduction session to the program. At this time, participants will be filmed in a brief interaction with a typically developing peer that will be used as a baseline indicator of their social fluency.

Participants will attend the social skills intervention program once a week for twelve weeks. Each week there will be approximately 90 minutes of group therapy which will be conducted like a seminar class: the principal investigator will teach and review social interaction skills and nuances, participants will be encouraged to take an active role in the class.

During the twelve week intervention there will be three review/fluency building sessions: week four, week eight, and week twelve. The group therapy sessions for these review weeks will simply review the material that was covered during the prior three weeks. Participants will then practice what they have learned by having a conversation with a peer that will be taped.

Following the group therapy session each week, participants will join six typically developing peers in a 90 minute introductory photography class taught by one of the study's co-investigators. The photography class will give the participants the opportunity to practice the skills learned in group therapy with their peer group.

Participants will once again complete a battery of clinical and self-report outcome measures which will serve as the post-test measurements for the study. They will be filmed in a brief interaction with a typically developing peer which will be coded to obtain post-test social interaction skills and fluency scores. These evaluations will occur at completion of social skills program, and at three month follow-up.

Eligibility criteria: Inclusion Criteria:

* Between 13 and 17 years of age
* A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Autism Disorders Interview-Revised (ADIR; Rutter \& LeCourteur, 1995)
* An IQ of 70 or above on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990)
* Local to Central Pennsylvania region

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

Primary outcomes:
measure: Social Fluency
timeFrame: 12 week, 3 month
Secondary outcomes:
measure: Loneliness Scale (Asher & Wheeler, 1985)
timeFrame: 12 week, 3 month
measure: Social Responsiveness Scale (SRS; Constantino, 2002)
timeFrame: 12 week, 3 month
measure: Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
timeFrame: 12 week, 3 month
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Micheal J Murray, M.D.
role: PRINCIPAL_INVESTIGATOR
References: