NCT04468620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

May 14, 2020

Last Update Submit

February 2, 2021

Conditions

Keywords

vocational rehabilitationMental healthsocial skillsemployment

Outcome Measures

Primary Outcomes (12)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    85-95 days post intervention

Secondary Outcomes (6)

  • Baseline Depression

    immediately pre-intervention

  • Change in Depression

    immediately post-intervention

  • Change in Depression

    85-95 days post-intervention

  • Baseline Anxiety

    immediately pre-intervention

  • Changes in Anxiety

    immediately post-intervention

  • +1 more secondary outcomes

Study Arms (1)

ASSET Intervention

EXPERIMENTAL

13-session group intervention

Behavioral: Assistive Soft Skills & Employment Training (ASSET)

Interventions

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.

ASSET Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Gulf Coast University

Fort Myers, Florida, 33965, United States

Location

Related Publications (6)

  • 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: 16584101BACKGROUND
  • 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: 21516433BACKGROUND
  • 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: 11556941BACKGROUND
  • 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: 16717171BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Psychological Well-BeingSocial Skills

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSocial Behavior

Study Officials

  • Annemarie Connor, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

July 13, 2020

Study Start

September 16, 2019

Primary Completion

April 15, 2020

Study Completion

June 30, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations