<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/NCT04468620</url>
  </required_header>
  <id_info>
    <org_study_id>2018-11</org_study_id>
    <nct_id>NCT04468620</nct_id>
  </id_info>
  <brief_title>A Peer-mediated Vocational Social Skills Program for Young Adults With Autism</brief_title>
  <official_title>A Peer-mediated Vocational Social Skills Program for Adolescents &amp; Young Adults With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida Gulf Coast University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida Gulf Coast University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Assistive Social Skills and Employment Training program (ASSET) is an&#xD;
      occupationally-based, work-related social skills intervention, designed to address the&#xD;
      pre-employment and mental health needs of young adults with high-functioning autism in&#xD;
      school-to-work transition. Knowing that occupational therapy (OT) services designed to&#xD;
      address the post-secondary transition needs of this population have been largely unexplored,&#xD;
      and recognizing the need for OT students to gain practical experience facilitating&#xD;
      psychosocial groups, this study seeks to: (1) evaluate program impacts on participants'&#xD;
      psychosocial functioning and work readiness, and (2) pilot the use of OT students as group&#xD;
      facilitators. The study will follow a mixed-methods, single group design, using&#xD;
      questionnaires and interviews to assess skills, confidence, and psychological wellness before&#xD;
      intervention, immediately after, and at follow-up. OT students will also be interviewed and&#xD;
      complete pre- and post-intervention assessments of clinical self-efficacy and stress. This&#xD;
      project supports the AOTF's objectives by: (1) building OT academic program capacity to&#xD;
      partner with university services and the autism community to improve transition outcomes in&#xD;
      an underserved group, (2) laying the groundwork for larger, more rigorous studies of ASSET's&#xD;
      effectiveness, and (3) gathering pilot data to support future grant applications at the&#xD;
      federal level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two specific aims of this study. First, researchers will test the effects of the&#xD;
      ASSET Program on: (a) improving social function, work-related social skills, and&#xD;
      self-efficacy (primary outcomes), and (b) psychological wellness (secondary outcome) using a&#xD;
      quasi-experimental, single group, time series design. Secondly and concurrently, researchers&#xD;
      will collect pilot data on the &quot;near peer&quot; mediation aspects of the intervention from the&#xD;
      perspectives of OT students and ASSET group participants. Specifically, researchers will&#xD;
      measure occupational therapy student facilitators' perceived stress, clinical self-efficacy,&#xD;
      and educational value of the experience; and collect data on ASSET participants' ratings of&#xD;
      the quality of the facilitation as delivered by occupational therapy graduate students.&#xD;
&#xD;
      Design: Using a quasi-experimental, repeated time series design, this convergent parallel&#xD;
      mixed-methods pilot study will use quantitative data to measure change in primary and&#xD;
      secondary outcomes, while qualitative data (session feedback forms, pre/post/follow-up&#xD;
      interviews) will be collected in order to compare or relate themes to the quantitative&#xD;
      findings. Building from the results of our earlier work using professional facilitators, the&#xD;
      following two aims will be examined. Psychometric properties of instruments are available in&#xD;
      the Appendices.&#xD;
&#xD;
      AIM 1: Evaluate the effects of the ASSET program on the social function, work-related social&#xD;
      skills knowledge, confidence (primary outcomes) and psychological wellness (secondary&#xD;
      outcomes) of a group of college students with HFASD immediately after the 13-week&#xD;
      intervention delivered by graduate students and at 3-month follow-up.&#xD;
&#xD;
      Research Questions and Hypotheses:&#xD;
&#xD;
      Q1: Is ASSET associated with improvements in work-related social skills knowledge, social&#xD;
      function, and social self-efficacy when facilitated by OTS? H1: Immediately post&#xD;
      intervention, on average, ASSET participants will show statistically significant improvements&#xD;
      in primary outcomes (work-related social skills knowledge, social function, and social&#xD;
      self-efficacy).&#xD;
&#xD;
      H2: At three-month follow-up, on average, ASSET participants will show declines in primary&#xD;
      outcomes, yet scores will remain above baseline and at statistically significant levels.&#xD;
&#xD;
      H3: Immediately post intervention, on average, ASSET participants will show clinically&#xD;
      significant improvements in secondary mental health outcomes (anxiety and depression);&#xD;
      however, these gains may not reach the level of statistical significance.&#xD;
&#xD;
      H4: At three-month follow-up, on average, ASSET participants will show continued improvements&#xD;
      in secondary mental health outcomes (anxiety and depression), with improvements in anxiety&#xD;
      reaching a level of statistical significance when compared to baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</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>Baseline Social Functioning</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>Social Responsiveness System-2 (Constantino &amp; Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Social Functioning</measure>
    <time_frame>immediately post intervention</time_frame>
    <description>Social Responsiveness System-2 (Constantino &amp; Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Social Functioning</measure>
    <time_frame>85-95 days post intervention</time_frame>
    <description>Social Responsiveness System-2 (Constantino &amp; Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline General Self-efficacy</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in General Self-efficacy</measure>
    <time_frame>immediately post intervention</time_frame>
    <description>The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in General Self-efficacy</measure>
    <time_frame>85-95 days post intervention</time_frame>
    <description>The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Perceived Empathic Self-efficacy</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Empathic Self-efficacy</measure>
    <time_frame>immediately post intervention</time_frame>
    <description>The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Empathic Self-efficacy</measure>
    <time_frame>85-95 days post intervention</time_frame>
    <description>The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Perceived Social Self-efficacy</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Social Self-efficacy</measure>
    <time_frame>immediately post intervention</time_frame>
    <description>The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Social Self-efficacy</measure>
    <time_frame>85-95 days post intervention</time_frame>
    <description>The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline Depression</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: &quot;Little interest or pleasure in doing things,&quot; and &quot;Feeling down, depressed, or hopeless.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>immediately post-intervention</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: &quot;Little interest or pleasure in doing things,&quot; and &quot;Feeling down, depressed, or hopeless.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>85-95 days post-intervention</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: &quot;Little interest or pleasure in doing things,&quot; and &quot;Feeling down, depressed, or hopeless.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Anxiety</measure>
    <time_frame>immediately pre-intervention</time_frame>
    <description>The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: &quot;Feeling nervous, anxious or on edge,&quot; and &quot;Worrying too much about different things.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Anxiety</measure>
    <time_frame>immediately post-intervention</time_frame>
    <description>The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: &quot;Feeling nervous, anxious or on edge,&quot; and &quot;Worrying too much about different things.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Anxiety</measure>
    <time_frame>85-95 days post-intervention</time_frame>
    <description>The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: &quot;Feeling nervous, anxious or on edge,&quot; and &quot;Worrying too much about different things.&quot; Lower scores indicate less symptoms.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Autism Spectrum Disorder High-Functioning</condition>
  <arm_group>
    <arm_group_label>ASSET Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>13-session group intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assistive Soft Skills &amp; Employment Training (ASSET)</intervention_name>
    <description>The ASSET curriculum covers six key social skill areas: (a) Communication; (b) Networking; (c) Attitude &amp; Enthusiasm; (d) Teamwork; (e) Problem Solving &amp; Critical Thinking; and (f) Professionalism, as well as new content added based on our pilot findings (Mental Health; Stress Management and Self-Advocacy; and Awareness of Self &amp; Others). The schedule includes two sessions for Communication and Professionalism, and a graduation session; thus, bringing the total number of sessions to 13. The structural elements of the training format include didactic lecture, experiential activities, group discussions, role-plays, performance feedback,and weekly take-home assignments. A key element is a social hour following each 90-minute session, in which participants practice learned skills while sharing a meal.</description>
    <arm_group_label>ASSET Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-29 years of age&#xD;
&#xD;
          -  previous diagnosis of autistic disorders, Asperger's disorder, Pervasive Developmental&#xD;
             Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no current participation in other work related social skills treatment&#xD;
&#xD;
          -  no history of other neurological disorders&#xD;
&#xD;
          -  no history of major mental illness (e.g., schizophrenia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annemarie Connor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Gulf Coast University</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33965</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Caprara GV, Steca P, Gerbino M, Pacielloi M, Vecchio GM. Looking for adolescents' well-being: self-efficacy beliefs as determinants of positive thinking and happiness. Epidemiol Psichiatr Soc. 2006 Jan-Mar;15(1):30-43. doi: 10.1017/s1121189x00002013.</citation>
    <PMID>16584101</PMID>
  </reference>
  <reference>
    <citation>Aldridge FJ, Gibbs VM, Schmidhofer K, Williams M. Investigating the clinical usefulness of the Social Responsiveness Scale (SRS) in a tertiary level, autism spectrum disorder specific assessment clinic. J Autism Dev Disord. 2012 Feb;42(2):294-300. doi: 10.1007/s10803-011-1242-9.</citation>
    <PMID>21516433</PMID>
  </reference>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
    <PMID>11556941</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <results_reference>
    <citation>Connor A, Sung C, Strain A, Zeng S, Fabrizi S. Building Skills, Confidence, and Wellness: Psychosocial Effects of Soft Skills Training for Young Adults with Autism. J Autism Dev Disord. 2020 Jun;50(6):2064-2076. doi: 10.1007/s10803-019-03962-w.</citation>
    <PMID>30879257</PMID>
  </results_reference>
  <results_reference>
    <citation>Sung C, Connor A, Chen J, Lin CC, Kuo HJ, Chun J. Development, feasibility, and preliminary efficacy of an employment-related social skills intervention for young adults with high-functioning autism. Autism. 2019 Aug;23(6):1542-1553. doi: 10.1177/1362361318801345. Epub 2018 Dec 22.</citation>
    <PMID>30582341</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vocational rehabilitation</keyword>
  <keyword>Mental health</keyword>
  <keyword>social skills</keyword>
  <keyword>employment</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/NCT04468620
org study id: 2018-11
nct id: NCT04468620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Assistive Social Skills and Employment Training program (ASSET) is an
      occupationally-based, work-related social skills intervention, designed to address the
      pre-employment and mental health needs of young adults with high-functioning autism in
      school-to-work transition. Knowing that occupational therapy (OT) services designed to
      address the post-secondary transition needs of this population have been largely unexplored,
      and recognizing the need for OT students to gain practical experience facilitating
      psychosocial groups, this study seeks to: (1) evaluate program impacts on participants'
      psychosocial functioning and work readiness, and (2) pilot the use of OT students as group
      facilitators. The study will follow a mixed-methods, single group design, using
      questionnaires and interviews to assess skills, confidence, and psychological wellness before
      intervention, immediately after, and at follow-up. OT students will also be interviewed and
      complete pre- and post-intervention assessments of clinical self-efficacy and stress. This
      project supports the AOTF's objectives by: (1) building OT academic program capacity to
      partner with university services and the autism community to improve transition outcomes in
      an underserved group, (2) laying the groundwork for larger, more rigorous studies of ASSET's
      effectiveness, and (3) gathering pilot data to support future grant applications at the
      federal level.
There are two specific aims of this study. First, researchers will test the effects of the
      ASSET Program on: (a) improving social function, work-related social skills, and
      self-efficacy (primary outcomes), and (b) psychological wellness (secondary outcome) using a
      quasi-experimental, single group, time series design. Secondly and concurrently, researchers
      will collect pilot data on the "near peer" mediation aspects of the intervention from the
      perspectives of OT students and ASSET group participants. Specifically, researchers will
      measure occupational therapy student facilitators' perceived stress, clinical self-efficacy,
      and educational value of the experience; and collect data on ASSET participants' ratings of
      the quality of the facilitation as delivered by occupational therapy graduate students.

      Design: Using a quasi-experimental, repeated time series design, this convergent parallel
      mixed-methods pilot study will use quantitative data to measure change in primary and
      secondary outcomes, while qualitative data (session feedback forms, pre/post/follow-up
      interviews) will be collected in order to compare or relate themes to the quantitative
      findings. Building from the results of our earlier work using professional facilitators, the
      following two aims will be examined. Psychometric properties of instruments are available in
      the Appendices.

      AIM 1: Evaluate the effects of the ASSET program on the social function, work-related social
      skills knowledge, confidence (primary outcomes) and psychological wellness (secondary
      outcomes) of a group of college students with HFASD immediately after the 13-week
      intervention delivered by graduate students and at 3-month follow-up.

      Research Questions and Hypotheses:

      Q1: Is ASSET associated with improvements in work-related social skills knowledge, social
      function, and social self-efficacy when facilitated by OTS? H1: Immediately post
      intervention, on average, ASSET participants will show statistically significant improvements
      in primary outcomes (work-related social skills knowledge, social function, and social
      self-efficacy).

      H2: At three-month follow-up, on average, ASSET participants will show declines in primary
      outcomes, yet scores will remain above baseline and at statistically significant levels.

      H3: Immediately post intervention, on average, ASSET participants will show clinically
      significant improvements in secondary mental health outcomes (anxiety and depression);
      however, these gains may not reach the level of statistical significance.

      H4: At three-month follow-up, on average, ASSET participants will show continued improvements
      in secondary mental health outcomes (anxiety and depression), with improvements in anxiety
      reaching a level of statistical significance when compared to baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Baseline Social Functioning
time frame: immediately pre-intervention
description: Social Responsiveness System-2 (Constantino & Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.
measure: Change in Social Functioning
time frame: immediately post intervention
description: Social Responsiveness System-2 (Constantino & Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.
measure: Change in Social Functioning
time frame: 85-95 days post intervention
description: Social Responsiveness System-2 (Constantino & Gruber, 2012), 65-item rating scale measuring social functioning categorized into five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation and Restricted Interests, and Repetitive Behavior. Each item is scored on a 4-point Likert-type scale, ranging from 1 (not true) to 4 (almost always true). A score decrease indicates improved functioning.
measure: Baseline General Self-efficacy
time frame: immediately pre-intervention
description: The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.
measure: Change in General Self-efficacy
time frame: immediately post intervention
description: The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.
measure: Change in General Self-efficacy
time frame: 85-95 days post intervention
description: The General Self-Efficacy Scale (GSE; Schwarzer and Jerusalem 1995) is a ten-item, four point Likert-type scale, ranging from 1 (not true at all) to 5 (exactly true), which measures perceived ability to cope with challenges. Higher scores indicate higher functioning.
measure: Baseline Perceived Empathic Self-efficacy
time frame: immediately pre-intervention
description: The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Change in Perceived Empathic Self-efficacy
time frame: immediately post intervention
description: The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Change in Perceived Empathic Self-efficacy
time frame: 85-95 days post intervention
description: The Perceived Empathic Self-Efficacy Scale (PESE; Caprara and Steca 2005) is a six-item self-report inventory, which measures participants' perceived ability to exercise theory of mind. The PESE uses a five-point Likert-type scale, ranging from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Baseline Perceived Social Self-efficacy
time frame: immediately pre-intervention
description: The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Change in Perceived Social Self-efficacy
time frame: immediately post intervention
description: The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Change in Perceived Social Self-efficacy
time frame: 85-95 days post intervention
description: The Perceived Social Self-Efficacy Scale (PSSE; Caprara and Steca 2005) is a five-item inventory used to measure participants' self-perceived ability to express opinions, share personal experiences, work cooperatively, and manage interpersonal conflict. Respondents rate each item on a five-point scale from 1 (not well at all) to 5 (very well). Higher scores indicate higher functioning.
measure: Baseline Depression
time frame: immediately pre-intervention
description: The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: "Little interest or pleasure in doing things," and "Feeling down, depressed, or hopeless." Lower scores indicate less symptoms.
measure: Change in Depression
time frame: immediately post-intervention
description: The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: "Little interest or pleasure in doing things," and "Feeling down, depressed, or hopeless." Lower scores indicate less symptoms.
measure: Change in Depression
time frame: 85-95 days post-intervention
description: The Patient Health Questionnaire-9 (PHQ-9; Spitzer et al. 2000) is a nine-item self-report inventory used to assess depressive symptoms. The PHQ-9 uses a four-point Likert-type scale, ranging from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. Sample items include: "Little interest or pleasure in doing things," and "Feeling down, depressed, or hopeless." Lower scores indicate less symptoms.
measure: Baseline Anxiety
time frame: immediately pre-intervention
description: The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: "Feeling nervous, anxious or on edge," and "Worrying too much about different things." Lower scores indicate less symptoms.
measure: Changes in Anxiety
time frame: immediately post-intervention
description: The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: "Feeling nervous, anxious or on edge," and "Worrying too much about different things." Lower scores indicate less symptoms.
measure: Changes in Anxiety
time frame: 85-95 days post-intervention
description: The General Anxiety Disorder Questionnaire-7 (GAD-7; Spitzer et al., 2006) is a seven-item self-report measure used to measure anxiety. The GAD-7 uses a four-point Likert-type scale to assess frequency of symptoms, ranging from 0 (not at all) to 3 (nearly every day) with total scores range from 0 to 21. Sample items include: "Feeling nervous, anxious or on edge," and "Worrying too much about different things." Lower scores indicate less symptoms.
arm group label: ASSET Intervention
arm group type: Experimental
description: 13-session group intervention
intervention type: Behavioral
intervention name: Assistive Soft Skills & Employment Training (ASSET)
description: The ASSET curriculum covers six key social skill areas: (a) Communication; (b) Networking; (c) Attitude & Enthusiasm; (d) Teamwork; (e) Problem Solving & Critical Thinking; and (f) Professionalism, as well as new content added based on our pilot findings (Mental Health; Stress Management and Self-Advocacy; and Awareness of Self & Others). The schedule includes two sessions for Communication and Professionalism, and a graduation session; thus, bringing the total number of sessions to 13. The structural elements of the training format include didactic lecture, experiential activities, group discussions, role-plays, performance feedback,and weekly take-home assignments. A key element is a social hour following each 90-minute session, in which participants practice learned skills while sharing a meal.
arm group label: ASSET Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Annemarie Connor, PhD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
citation: Caprara GV, Steca P, Gerbino M, Pacielloi M, Vecchio GM. Looking for adolescents' well-being: self-efficacy beliefs as determinants of positive thinking and happiness. Epidemiol Psichiatr Soc. 2006 Jan-Mar;15(1):30-43. doi: 10.1017/s1121189x00002013.
PMID: 16584101
citation: Aldridge FJ, Gibbs VM, Schmidhofer K, Williams M. Investigating the clinical usefulness of the Social Responsiveness Scale (SRS) in a tertiary level, autism spectrum disorder specific assessment clinic. J Autism Dev Disord. 2012 Feb;42(2):294-300. doi: 10.1007/s10803-011-1242-9.
PMID: 21516433
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
citation: Connor A, Sung C, Strain A, Zeng S, Fabrizi S. Building Skills, Confidence, and Wellness: Psychosocial Effects of Soft Skills Training for Young Adults with Autism. J Autism Dev Disord. 2020 Jun;50(6):2064-2076. doi: 10.1007/s10803-019-03962-w.
PMID: 30879257
citation: Sung C, Connor A, Chen J, Lin CC, Kuo HJ, Chun J. Development, feasibility, and preliminary efficacy of an employment-related social skills intervention for young adults with high-functioning autism. Autism. 2019 Aug;23(6):1542-1553. doi: 10.1177/1362361318801345. Epub 2018 Dec 22.
PMID: 30582341
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No