Autism Spectrum Disorder High-FunctioningNCT04468620
A Peer-mediated Vocational Social Skills Program for Young Adults With Autism
A study testing Assistive Soft Skills & Employment Training (ASSET) in people with Autism Spectrum Disorder High-Functioning, run by Florida Gulf Coast University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder High-Functioning
- What is being tested?
- Assistive Soft Skills & Employment Training (ASSET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 years of age
- previous diagnosis of autistic disorders, Asperger's disorder, Pervasive Developmental Disorder
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Gulf Coast University
Fort Myers, Florida, 33965
About this study
Official title: A Peer-mediated Vocational Social Skills Program for Adolescents & Young Adults With Autism
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.
Read the 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.
- Being tested
- Assistive Soft Skills & Employment Training (ASSET)
- Keywords
- vocational rehabilitation, Mental health, social skills, employment
- Medical subject headings
- Psychological Well-Being, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive Soft Skills & Employment Training (ASSET)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ASSET Intervention | Experimental | 13-session group intervention Receives: Behavioral: Assistive Soft Skills & Employment Training (ASSET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 85-95 days post intervention
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 85-95 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start16 Sep 2019
- Primary completion15 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder High-FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemarie Connor, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468620
- Sponsor's protocol ID
- 2018-11
- Status last verified
- Feb 2021
- First submitted
- 14 May 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16584101Aldridge 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.
PubMed 21516433Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171Connor 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.
PubMed 30879257Sung 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.
PubMed 30582341
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer-mediated Vocational Social Skills Program for Adolescents & Young Adults With Autism
- ClinicalTrials.gov ID
- NCT04468620
- Acronym / sponsor ID
- 2018-11
- Keywords
- vocational rehabilitation, Mental health, social skills, employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASSET Intervention | Experimental | Behavioral: Assistive Soft Skills & Employment Training (ASSET)13-session group intervention |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-29 years of age
- previous diagnosis of autistic disorders, Asperger's disorder, Pervasive Developmental Disorder
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ASSET Intervention |
Primary outcome
Baseline Social Functioning
Time frame: 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.
Change in Social Functioning
Time frame: 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.
Change in Social Functioning
Time frame: 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.
Baseline General Self-efficacy
Time frame: 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.
Change in General Self-efficacy
Time frame: 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.
Change in General Self-efficacy
Time frame: 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.
Baseline Perceived Empathic Self-efficacy
Time frame: 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.
Change in Perceived Empathic Self-efficacy
Time frame: 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.
Change in Perceived Empathic Self-efficacy
Time frame: 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.
Baseline Perceived Social Self-efficacy
Time frame: 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.
Change in Perceived Social Self-efficacy
Time frame: 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.
Change in Perceived Social Self-efficacy
Time frame: 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.
6 secondary outcomes
Baseline Depression
Time frame: immediately pre-intervention
Change in Depression
Time frame: immediately post-intervention
Change in Depression
Time frame: 85-95 days post-intervention
Baseline Anxiety
Time frame: immediately pre-intervention
Changes in Anxiety
Time frame: immediately post-intervention
Changes in Anxiety
Time frame: 85-95 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 16584101Caprara 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.
- Background: PubMed 21516433Aldridge 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
- Results publication: PubMed 30879257Connor 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.
- Results publication: PubMed 30582341Sung 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.
- Individual participant dataSharing planned: No
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Autism, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemarie Connor, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive Soft Skills & Employment Training (ASSET) in people with Autism Spectrum Disorder High-Functioning, run by Florida Gulf Coast University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Social Functioning (time frame: immediately pre-intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468620, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.