An interventional study of Assistive Soft Skills & Employment Training (ASSET) in Autism Spectrum Disorder High-Functioning, sponsored by Florida Gulf Coast University. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Florida Gulf Coast University · Not applicable, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Florida Gulf Coast University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Baseline Social Functioning
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.
Time frame: immediately pre-intervention
Change in Social Functioning
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.
Time frame: immediately post intervention
Change in Social Functioning
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.
Time frame: 85-95 days post intervention
Baseline General Self-efficacy
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.
Time frame: immediately pre-intervention
Change in General Self-efficacy
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.
Time frame: immediately post intervention
Change in General Self-efficacy
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.
Time frame: 85-95 days post intervention
Baseline Perceived Empathic Self-efficacy
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.
Time frame: immediately pre-intervention
Change in Perceived Empathic Self-efficacy
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.
Time frame: immediately post intervention
Change in Perceived Empathic Self-efficacy
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.
Time frame: 85-95 days post intervention
Baseline Perceived Social Self-efficacy
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.
Time frame: immediately pre-intervention
Change in Perceived Social Self-efficacy
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.
Time frame: immediately post intervention
Change in Perceived Social Self-efficacy
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.
Time frame: 85-95 days post intervention
Baseline Depression
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.
Time frame: immediately pre-intervention
Change in Depression
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.
Time frame: immediately post-intervention
Change in Depression
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.
Time frame: 85-95 days post-intervention
Baseline Anxiety
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.
Time frame: immediately pre-intervention
Changes in Anxiety
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.
Time frame: immediately post-intervention
Changes in Anxiety
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.
Time frame: 85-95 days post-intervention
Plan to share: No
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Florida Gulf Coast University