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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01031823
Other study ID # 32300
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date July 10, 2013

Study information

Verified date June 2019
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 10, 2013
Est. primary completion date October 2012
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

- 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

Study Design


Intervention

Behavioral:
Multi-Media Social Skills Training Program
All individuals will participate in a twelve week social skills training program designed to enhance the social skills of adolescents with Asperger's Disorder or high-functioning autism. The intervention is comprised of both group therapy and peer generalization.

Locations

Country Name City State
United States Penn State College of Medicine, Penn State Milton S. Hershey Medical Center 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 Social Fluency 12 week, 3 month
Secondary Loneliness Scale (Asher & Wheeler, 1985) 12 week, 3 month
Secondary Social Responsiveness Scale (SRS; Constantino, 2002) 12 week, 3 month
Secondary Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) 12 week, 3 month
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