A Peer-mediated Vocational Social Skills Program for Young Adults With Autism

Sponsor
Florida Gulf Coast University (Other)
Overall Status
Completed
CT.gov ID
NCT04468620
Collaborator
(none)
15
1
1
9.5
1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Assistive Soft Skills & Employment Training (ASSET)
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Peer-mediated Vocational Social Skills Program for Adolescents & Young Adults With Autism
Actual Study Start Date :
Sep 16, 2019
Actual Primary Completion Date :
Apr 15, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASSET Intervention

13-session group intervention

Behavioral: Assistive Soft Skills & Employment Training (ASSET)
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.

Outcome Measures

Primary Outcome Measures

  1. Baseline Social Functioning [immediately pre-intervention]

    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.

  2. Change in Social Functioning [immediately post intervention]

    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.

  3. Change in Social Functioning [85-95 days post intervention]

    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.

  4. Baseline General Self-efficacy [immediately pre-intervention]

    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.

  5. Change in General Self-efficacy [immediately post intervention]

    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.

  6. Change in General Self-efficacy [85-95 days post intervention]

    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.

  7. Baseline Perceived Empathic Self-efficacy [immediately pre-intervention]

    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.

  8. Change in Perceived Empathic Self-efficacy [immediately post intervention]

    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.

  9. Change in Perceived Empathic Self-efficacy [85-95 days post intervention]

    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.

  10. Baseline Perceived Social Self-efficacy [immediately pre-intervention]

    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.

  11. Change in Perceived Social Self-efficacy [immediately post intervention]

    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.

  12. Change in Perceived Social Self-efficacy [85-95 days post intervention]

    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.

Secondary Outcome Measures

  1. Baseline Depression [immediately pre-intervention]

    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.

  2. Change in Depression [immediately post-intervention]

    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.

  3. Change in Depression [85-95 days post-intervention]

    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.

  4. Baseline Anxiety [immediately pre-intervention]

    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.

  5. Changes in Anxiety [immediately post-intervention]

    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.

  6. Changes in Anxiety [85-95 days post-intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18-29 years of age

  • previous diagnosis of autistic disorders, Asperger's disorder, Pervasive Developmental Disorder

Exclusion Criteria:
  • no current participation in other work related social skills treatment

  • no history of other neurological disorders

  • no history of major mental illness (e.g., schizophrenia)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida Gulf Coast University Fort Myers Florida United States 33965

Sponsors and Collaborators

  • Florida Gulf Coast University

Investigators

  • Principal Investigator: Annemarie Connor, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Florida Gulf Coast University
ClinicalTrials.gov Identifier:
NCT04468620
Other Study ID Numbers:
  • 2018-11
First Posted:
Jul 13, 2020
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Florida Gulf Coast University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021