NCT01031823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2013

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

December 12, 2009

Last Update Submit

June 4, 2019

Conditions

Keywords

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Social Fluency

    12 week, 3 month

Secondary Outcomes (3)

  • Loneliness Scale (Asher & Wheeler, 1985)

    12 week, 3 month

  • Social Responsiveness Scale (SRS; Constantino, 2002)

    12 week, 3 month

  • Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)

    12 week, 3 month

Study Arms (1)

Social Skills Training

EXPERIMENTAL

All participants will take part in this arm of the study.

Behavioral: Multi-Media Social Skills Training Program

Interventions

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.

Social Skills Training

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Asperger SyndromeAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Micheal J Murray, M.D.

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2009

First Posted

December 15, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

July 10, 2013

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations