<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02995564</url>
  </required_header>
  <id_info>
    <org_study_id>41078EP</org_study_id>
    <nct_id>NCT02995564</nct_id>
  </id_info>
  <brief_title>The Multi-Media Social Skills Project for Adults</brief_title>
  <official_title>The Multi-Media Social Skills Project for Adults: Validation of an Intervention for Adults With Autism Spectrum Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennsylvania Bureau of Autism Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is investigating the development of a social skills training program for adults&#xD;
      with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal&#xD;
      Investigator for this study is Dr. Michael Murray, the director of the Autism Studies&#xD;
      Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a&#xD;
      social skills training program to address and enhance the social skills of adults with&#xD;
      Asperger's Syndrome and high-functioning autism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During group study visits, a group of six young adults with Asperger's Syndrome or&#xD;
      high-functioning autism will meet weekly for about 90 minutes. The purpose of the group&#xD;
      sessions is to work on everyday social skills such as initiating and maintaining&#xD;
      conversations, establishing friendships, and dealing with situations such as job interviews&#xD;
      and dating.&#xD;
&#xD;
      A generalization session will be held every week after the group therapy session with&#xD;
      same-age peers who have been screened to participate in the study. The purpose of including&#xD;
      peers in the class is to give young adults with Asperger's syndrome and high-functioning&#xD;
      autism a chance to practice the social skills learned in the group study visit with a peer&#xD;
      group. Study participants will be paired with a typically developing peer for an outing in&#xD;
      the community to a nearby restaurant or shop or an in-class exercise such as a mock job&#xD;
      interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">April 9, 2018</completion_date>
  <primary_completion_date type="Actual">April 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Responsiveness Scale - Adult</measure>
    <time_frame>One week post-intervention</time_frame>
    <description>The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Video recording of Social Interaction</measure>
    <time_frame>One week post-intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achenbach Adult Behavior Checklist</measure>
    <time_frame>One week post-intervention</time_frame>
    <description>The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social and Emotional Loneliness Scale for Adults (SELSA)</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>The SELSA is a 37-item survey that assesses friendships and other relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Inventory (SSI)</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>The SSI is a 90-item survey that measures social competence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Phobia Inventory (SPIN)</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>The SPIN is a 17-item survey that asks about feelings in social situations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empathy Quotient</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>The EQ is a 60-item survey that assesses ability to relate to others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achenbach Adult Behavior Checklist - Self Report</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>A 126-item survey that asks about behaviors, problems, and substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Fluency Assessment</measure>
    <time_frame>one week post-intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achenbach Adult Behavior Checklist</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social and Emotional Loneliness Scale for Adults (SELSA)</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The SELSA is a 37-item survey that assesses friendships and other relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Inventory (SSI)</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The SSI is a 90-item survey that measures social competence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Phobia Inventory (SPIN)</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The SPIN is a 17-item survey that asks about feelings in social situations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empathy Quotient</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The EQ is a 60-item survey that assesses ability to relate to others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achenbach Adult Behavior Checklist - Self Report</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>A 126-item survey that asks about behaviors, problems, and substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Fluency Assessment</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsiveness Scale - Adult</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">199</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>Social Skills Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>social skills therapy</intervention_name>
    <description>Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.</description>
    <arm_group_label>Social Skills Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 35 years of age&#xD;
&#xD;
          -  Must be a Pennsylvania resident&#xD;
&#xD;
          -  A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by&#xD;
             the SRS-2&#xD;
&#xD;
          -  A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition&#xD;
&#xD;
          -  English as primary language spoken&#xD;
&#xD;
          -  Ability to fluently speak in full sentences&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A significant language delay&#xD;
&#xD;
          -  Difficulty with aggression directed at peers&#xD;
&#xD;
          -  A primary thought disorder&#xD;
&#xD;
          -  A secondary disorder of anxiety or depression so severe as to prevent the individual's&#xD;
             participation in the treatment&#xD;
&#xD;
          -  A current high school student at start of intervention&#xD;
&#xD;
          -  Low social motivation demonstrated through formalized assessment and/or by responses&#xD;
             given to screening interview&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Murray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Pennsylvania Psychiatric Institute Northeast Drive Clinic</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Murray</investigator_full_name>
    <investigator_title>Director of the Division of Autism Services</investigator_title>
  </responsible_party>
  <keyword>Social Skills</keyword>
  <keyword>Asperger's</keyword>
  <keyword>High-functioning autism</keyword>
  <keyword>Young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995564
org study id: 41078EP
nct id: NCT02995564
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Social Responsiveness Scale - Adult
time frame: One week post-intervention
description: The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.
measure: Video recording of Social Interaction
time frame: One week post-intervention
description: 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.
measure: Achenbach Adult Behavior Checklist
time frame: One week post-intervention
description: The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.
measure: Social and Emotional Loneliness Scale for Adults (SELSA)
time frame: one week post-intervention
description: The SELSA is a 37-item survey that assesses friendships and other relationships.
measure: Social Skills Inventory (SSI)
time frame: one week post-intervention
description: The SSI is a 90-item survey that measures social competence.
measure: Social Phobia Inventory (SPIN)
time frame: one week post-intervention
description: The SPIN is a 17-item survey that asks about feelings in social situations.
measure: Empathy Quotient
time frame: one week post-intervention
description: The EQ is a 60-item survey that assesses ability to relate to others.
measure: Achenbach Adult Behavior Checklist - Self Report
time frame: one week post-intervention
description: A 126-item survey that asks about behaviors, problems, and substance use.
measure: Social Fluency Assessment
time frame: one week post-intervention
description: 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.
measure: Achenbach Adult Behavior Checklist
time frame: three months post-intervention
description: The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.
measure: Social and Emotional Loneliness Scale for Adults (SELSA)
time frame: three months post-intervention
description: The SELSA is a 37-item survey that assesses friendships and other relationships.
measure: Social Skills Inventory (SSI)
time frame: three months post-intervention
description: The SSI is a 90-item survey that measures social competence.
measure: Social Phobia Inventory (SPIN)
time frame: three months post-intervention
description: The SPIN is a 17-item survey that asks about feelings in social situations.
measure: Empathy Quotient
time frame: three months post-intervention
description: The EQ is a 60-item survey that assesses ability to relate to others.
measure: Achenbach Adult Behavior Checklist - Self Report
time frame: three months post-intervention
description: A 126-item survey that asks about behaviors, problems, and substance use.
measure: Social Fluency Assessment
time frame: three months post-intervention
description: 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.
measure: Social Responsiveness Scale - Adult
time frame: three months post-intervention
description: The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.
arm group label: Social Skills Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: social skills therapy
description: Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.
arm group label: Social Skills Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Murray, MD
role: Principal Investigator
affiliation: Penn State College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Michael Murray
investigator title: Director of the Division of Autism Services
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No