NCT01836965

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

5.1 years

First QC Date

March 28, 2013

Last Update Submit

March 11, 2019

Conditions

Keywords

AspergersSocial SkillsAdolescentsHigh-functioning Autism

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention

    One Week Post-Intervention

  • Change from Baseline Loneliness Scale after Intervention

    One Week Post Intervention

  • Change from Baseline Multidimensional Anxiety Scale for Children after Intervention

    One Week Post-Intervention

  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention

    One Week Post-Intervention

  • Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up

    3 Month Follow Up

  • +3 more secondary outcomes

Study Arms (1)

Social Skills Intervention

EXPERIMENTAL

The intervention is a 12-week social skills training program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session (in the form of a photography class with typically developing peers) meeting once per week. Each cohort will consist of 6 adolescents with Aspergers or high-functioning autism, who will be joined by 6 typically-developing peers for the photography class. During the group therapy session adolescents will discuss and watch video clips addressing social skills topics relevant to their age group. They will have a chance to practice these skills when paired with a typically developing peer for the photography class.

Behavioral: Social Skills Intervention

Interventions

Twelve week manual based social skills curriculum targeting social fluency and responsiveness.

Social Skills Intervention

Eligibility Criteria

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

You may qualify if:

  • 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)

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
  • Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Psychiatry Clinic

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Michael Murray, MD

    Penn State College of Medicine

    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
MD

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 22, 2013

Study Start

March 1, 2013

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations