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Trial record 4 of 494 for:    Alcohol* OR Cocaine OR Shizophrenia OR social | First posted from 08/01/2016 to 01/16/2017

The Multi-Media Social Skills Project for Adults

This study is currently recruiting participants.
Verified January 2017 by Michael Murray, Milton S. Hershey Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02995564
First Posted: December 16, 2016
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Pennsylvania Bureau of Autism Services
Information provided by (Responsible Party):
Michael Murray, Milton S. Hershey Medical Center
  Purpose
This study is investigating the development of a social skills training program for adults with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal Investigator for this study is Dr. Michael Murray, the director of the Autism Studies Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a social skills training program to address and enhance the social skills of adults with Asperger's Syndrome and high-functioning autism.

Condition Intervention
Autism Spectrum Disorders Behavioral: social skills therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Multi-Media Social Skills Project for Adults: Validation of an Intervention for Adults With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Michael Murray, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Social Responsiveness Scale - Adult [ Time Frame: One week post-intervention ]
    The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.

  • Video recording of Social Interaction [ Time Frame: One week post-intervention ]
    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.


Secondary Outcome Measures:
  • Achenbach Adult Behavior Checklist [ Time Frame: One week post-intervention ]
    The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.

  • Social and Emotional Loneliness Scale for Adults (SELSA) [ Time Frame: one week post-intervention ]
    The SELSA is a 37-item survey that assesses friendships and other relationships.

  • Social Skills Inventory (SSI) [ Time Frame: one week post-intervention ]
    The SSI is a 90-item survey that measures social competence.

  • Social Phobia Inventory (SPIN) [ Time Frame: one week post-intervention ]
    The SPIN is a 17-item survey that asks about feelings in social situations.

  • Empathy Quotient [ Time Frame: one week post-intervention ]
    The EQ is a 60-item survey that assesses ability to relate to others.

  • Achenbach Adult Behavior Checklist - Self Report [ Time Frame: one week post-intervention ]
    A 126-item survey that asks about behaviors, problems, and substance use.

  • Social Fluency Assessment [ Time Frame: one week post-intervention ]
    Participants will be filmed in a brief interaction with a typically developing peer. These videos will be analyzed for indicators of social fluency such as eye contact, seconds of silence and number of questions asked.

  • Achenbach Adult Behavior Checklist [ Time Frame: three months post-intervention ]
    The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.

  • Social and Emotional Loneliness Scale for Adults (SELSA) [ Time Frame: three months post-intervention ]
    The SELSA is a 37-item survey that assesses friendships and other relationships.

  • Social Skills Inventory (SSI) [ Time Frame: three months post-intervention ]
    The SSI is a 90-item survey that measures social competence.

  • Social Phobia Inventory (SPIN) [ Time Frame: three months post-intervention ]
    The SPIN is a 17-item survey that asks about feelings in social situations.

  • Empathy Quotient [ Time Frame: three months post-intervention ]
    The EQ is a 60-item survey that assesses ability to relate to others.

  • Achenbach Adult Behavior Checklist - Self Report [ Time Frame: three months post-intervention ]
    A 126-item survey that asks about behaviors, problems, and substance use.

  • Social Fluency Assessment [ Time Frame: three months post-intervention ]
    Participants will be filmed in a brief interaction with a typically developing peer. These videos will be analyzed for indicators of social fluency such as eye contact, seconds of silence and number of questions asked.

  • Social Responsiveness Scale - Adult [ Time Frame: three months post-intervention ]
    The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.


Estimated Enrollment: 360
Study Start Date: July 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Skills Intervention
The intervention is a 16-week social skills therapy program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session 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 peer generalization portion. During the group therapy session young adults 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 typically developing peer volunteers.
Behavioral: social skills therapy
Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.

Detailed Description:

During group study visits, a group of six young adults with Asperger's Syndrome or high-functioning autism will meet weekly for about 90 minutes. The purpose of the group sessions is to work on everyday social skills such as initiating and maintaining conversations, establishing friendships, and dealing with situations such as job interviews and dating.

A generalization session will be held every week after the group therapy session with same-age peers who have been screened to participate in the study. The purpose of including peers in the class is to give young adults with Asperger's syndrome and high-functioning autism a chance to practice the social skills learned in the group study visit with a peer group. Study participants will be paired with a typically developing peer for an outing in the community to a nearby restaurant or shop or an in-class exercise such as a mock job interview.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 35 years of age
  • Must be a Pennsylvania resident
  • A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the SRS-2
  • A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition
  • English as primary language spoken
  • Ability to fluently speak in full sentences

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
  • A current high school student at start of intervention
  • Low social motivation demonstrated through formalized assessment and/or by responses given to screening interview
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995564


Contacts
Contact: Michael Klemick, B.S. (717) 531-0003 ext 284923 mklemick@hmc.psu.edu

Locations
United States, Pennsylvania
The Pennsylvania Psychiatric Institute Northeast Drive Clinic Recruiting
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Pennsylvania Bureau of Autism Services
Investigators
Principal Investigator: Michael Murray, MD Penn State College of Medicine
  More Information

Responsible Party: Michael Murray, Director of the Division of Autism Services, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02995564     History of Changes
Other Study ID Numbers: 41078EP
First Submitted: December 14, 2016
First Posted: December 16, 2016
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Murray, Milton S. Hershey Medical Center:
Social Skills
Asperger's
High-functioning autism
Young adults

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders