Clinical trial NCT04468620: A Peer-mediated Vocational Social Skills Program for Young Adults With Autism
Official title: A Peer-mediated Vocational Social Skills Program for Adolescents & Young Adults With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder High-Functioning
Keywords: vocational rehabilitation
Mental health
social skills
employment
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Baseline Social Functioning
timeFrame: immediately pre-intervention
measure: Change in Social Functioning
timeFrame: immediately post intervention
measure: Change in Social Functioning
timeFrame: 85-95 days post intervention
measure: Baseline General Self-efficacy
timeFrame: immediately pre-intervention
measure: Change in General Self-efficacy
timeFrame: immediately post intervention
measure: Change in General Self-efficacy
timeFrame: 85-95 days post intervention
measure: Baseline Perceived Empathic Self-efficacy
timeFrame: immediately pre-intervention
measure: Change in Perceived Empathic Self-efficacy
timeFrame: immediately post intervention
measure: Change in Perceived Empathic Self-efficacy
timeFrame: 85-95 days post intervention
measure: Baseline Perceived Social Self-efficacy
timeFrame: immediately pre-intervention
measure: Change in Perceived Social Self-efficacy
timeFrame: immediately post intervention
measure: Change in Perceived Social Self-efficacy
timeFrame: 85-95 days post intervention
Secondary outcomes:
measure: Baseline Depression
timeFrame: immediately pre-intervention
measure: Change in Depression
timeFrame: immediately post-intervention
measure: Change in Depression
timeFrame: 85-95 days post-intervention
measure: Baseline Anxiety
timeFrame: immediately pre-intervention
measure: Changes in Anxiety
timeFrame: immediately post-intervention
measure: Changes in Anxiety
timeFrame: 85-95 days post-intervention
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Gulf Coast University
state: Florida
Study officials:
affiliation: Assistant Professor
name: Annemarie Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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.