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Achieving Steady Work Among Adults With Autism Through Specialized Employment Program

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NaW
NaW-DS
Sponsored by
Lawrence Fung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Neurodiversity, ASD, Employment, Neurodiverse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Moderately functioning group of participants:

    • Males and females with ASD
    • Between the ages of 18-55
    • No significant current psychosocial stressors per history
    • Able to travel to work independently
    • Attended either an internship program, pre-employment training, or both
    • Possess an IQ between 60 and 90
  • High functioning group of participants:

    • Males and females with ASD
    • Between the ages of 18-55
    • No significant current psychosocial stressors per history
    • Able to travel to work independently
    • Attended either an internship program, pre-employment training, or both
    • Possess a college degree
    • Possess an IQ of 90 or above

Exclusion criteria:

  • DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.

Sites / Locations

  • Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neurodiversity at Work (NaW) Group

Neurodiversity at Work - Delayed Start (NaW-DS)

Arm Description

Individuals in this group will receive a 6-week Autism at Work pre-employment training. Upon onboarding, each individual will be supported by a team manager, a team buddy, a peer mentor, a job/life skills coach, a vocational rehabilitation counselor, and a personal counselor. Ongoing support for members of support circles will be provided during the 12 weeks immediately after onboarding.

Participants in this group will receive typical orientation for neurotypical employees after onboarding. The support of peer mentor, job/life skills coach, vocational rehabilitation counselor, and a personal counselor will start 6 months after onboarding. Managers, co-workers, team buddies and mentors for all recruited and hired employees in both groups will receive the same specialized training to enhance their abilities to work with individuals with ASD.

Outcomes

Primary Outcome Measures

Job Retention Rates
Compare job retention rates resulting from NaW starting before onboarding and NaW starting 6 months after onboarding (NaW-DS). The investigators predict that the NaW program will result in a higher rate of sustained employment in adults with ASD 15 months after onboarding when compared to NaW-DS.
Duration of Sustained Employment
Compare duration of sustained employment for NaW and NaW-DS. The investigators predict that the NaW program will result in a longer duration of sustained employment as compared to NaW-DS.
Costs of Employee Turnover
Determine the costs of employee turnover achieved from the NaW and NaW-DS.
Rates of Job Offers
Compare rates of job offers between internship programs and pre-employment training programs.
World Health Organization Quality of Life Assessment [WHOQOL-100]
Measures individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Purpose of measure: compare the change in Quality of Life (QoL) between NaW and NaW-DS for adults with ASD at month 15 post-onboarding; compare the trajectories of change in QoL between NaW and NaW-DS for adults with ASD over time. This scale consists of four domains: physical health, psychological, social relationships, and environment. A higher score indicates a better quality of life, while a lower score indicates a lower quality of life. There is a total of 100 items in this scale. The minimum score is 100, with the highest score being 500. The five point scale ranges from "Not at all" to " Extremely" (or "Completely" or "Very satisfied"). Subscales are combined to produce a total score.

Secondary Outcome Measures

Maslach's Burnout Measure
Designed to measure burnout as defined by the World Health Organization (WHO). The minimum score is 22, and the maximum score is 132. A lower score indicates lower levels of burnout, while a higher score indicates high levels of burnout. Each item is rated on two scales: a 6-point frequency scale, and a 7-point intensity scale. The frequency scale ranges from "A few times a year" to "Every day." The intensity scale ranges from "Very mild" to "Very strong; major."
Meyer and Allen's Affective Commitment Measure
The Affective Commitment Scale's items were written to assess affective orientation towards the organization. Some responses are reverse-coded, so higher and lower scores do not necessarily point to similar results across the board. Each item is rated on a 7-point scale, ranging from "Strongly disagree" to "Strongly agree." Scores range from a minimum of 8 to a maximum of 56.
Eisenberger's Perceived Organizational Support
This scale aims to measure perceived organizational support with regard to an individual feeling appreciated, supported, and cared for within their place of work. Some items are reverse-coded. The 7-point scale ranges from "Strongly disagree" to "Strongly agree." Scores range from a minimum of 8 to a maximum of 56.
Morgensen and Humphrey's Job Characteristics (WDQ)
This scale measures work autonomy, task variety, task significance, task identity, and feedback from one's job. It also measures job complexity, information processing, skill variety, and specialization. All items are measured on a 5-point scale, with 1 indicating "Strongly disagree" and 5 being equal to "Strongly agree." Scores range from a minimum of 44 to a maximum of 220. Scores are interpreted in varying ways throughout the instrument.
Judge's Global Job Satisfaction
This scale measures perceived job satisfaction. It consists of 8 individual questions with various response options, including a scale ranging from "Strongly agree" to "Strongly disagree", a "Yes/No" option, a second scale ranging from "Very dissatisfied" to "Very satisfied," and an item in which participants are asked to score their satisfaction by way of percentage allocation. There is no range or minimum/maximum scores in this measure.
MOAQ Subscale: Intent to Turnover
A 4-item scale with two 7-point scoring scales: "Strongly disagree/Strongly agree" and "Not at all likely/Extremely likely," measuring one's intent to turnover from a job. Scores range from a minimum of 3 to a maximum of 21, with a higher score indicating a higher likelihood of job turnover.
Work Motivation and Engagement (UWES)
A 17-item scale aimed at measuring one's work engagement within a current job. Each item is rated using either one the following 6-point scales: specific (1 = a few times a year or less; 6 = every day) or broad (0 = never; 1 = almost never; 6 = always). Both scales include an option for 'never' (0). The minimum score is 0, with the maximum score being 102. A higher score indicates greater levels of engagement and motivation, with a lower score indicating lower levels of the aforementioned qualities.
ANZ Financial Well-being Scale
An 11-item scale which measures relative financial comfort and well-being. Items are scored in multiple-choice form as well as three Likert-scale items. Multiple-choice items vary in language but generally aim to measure the degree to which the participant is able to cover necessary expenses and their feelings regarding their financial situation. Some items are reverse-scored, thus making a higher/lower score not necessarily indicative of financial well-being or lack thereof.

Full Information

First Posted
September 24, 2019
Last Updated
September 17, 2021
Sponsor
Lawrence Fung
Collaborators
3R Behavioral Solutions, Rangam Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT04107064
Brief Title
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
Official Title
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lawrence Fung
Collaborators
3R Behavioral Solutions, Rangam Consultants

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Individuals with autism spectrum disorder (ASD) have significantly higher levels of unemployment and underemployment compared to their typically developing peers and all other groups with neurodevelopmental disorders, even though major companies that have employed and trained young people with ASD acclaim their significant innovations in their companies. The investigators hope to examine the effects of specialized employment support programs, over current traditional vocational rehabilitation approaches, for adults with ASD on their ability to maintain steady employment and overall benefit to the organizations at which they will be employed. The investigators predict that Stanford University's Neurodiversity at Work (NaW) Program will improve employment outcomes and positively impact the overall quality of life of individuals with ASD in this program. The investigators hope that the findings of the study will lead to the advancement of programs aimed to support individuals with ASD.
Detailed Description
To date, there has been limited research examining effects of specialized employment support programs (such as Stanford's Neurodiversity at Work) for adults with ASD. Results from this study will have substantial positive impact on the field because they will significantly elevate the investigators' understanding of the factors involved in successful employment and QoL outcomes in individuals with ASD. Furthermore, understanding the trajectories of psychiatric symptoms, employment outcomes and QoL will facilitate the development of educational tools, training materials and intervention tools to help in improving overall outcomes of individuals with ASD. The study has four specific aims that the investigators hope will contribute towards the advancement and proliferation of programs, such as Stanford's Neurodiversity at Work (NaW) aimed to support individuals with ASD, both in in the workplace and beyond. The investigators' first aim is to compare job retention rates resulting from NaW starting before onboarding and NaW starting 6 months after onboarding (NaW-DS) for adults with ASD, as well as compare duration of sustained employment for NaW and NaW-DS (NaW-delayed start). The second aim is to compare the change in QoL between NaW and NaW-DS for adults with ASD at month 15 past onboarding. The investigators predict that NaW will result in a higher QoL, as measured by the World Health Organization Quality of Life assessment (WHOQOL-100), in adults with ASD, compared to NaW-DS. The investigators also have an exploratory aim of determining costs of employee turnover achieved from the NaW and NaW-DS, as well as comparing rates of job offers between specialized internship programs (IP) and specialized pre-employment training programs (PT). Additionally, behavioral assessments will be administered to participants throughout the duration of the study as additional exploratory measures. Results from this study will provide an evidence base for the understanding of trajectories of psychiatric symptoms, employment outcomes and QoL will facilitate the development of education tools, training materials and intervention tools to help improving overall outcomes of individuals with ASD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
Neurodiversity, ASD, Employment, Neurodiverse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurodiversity at Work (NaW) Group
Arm Type
Experimental
Arm Description
Individuals in this group will receive a 6-week Autism at Work pre-employment training. Upon onboarding, each individual will be supported by a team manager, a team buddy, a peer mentor, a job/life skills coach, a vocational rehabilitation counselor, and a personal counselor. Ongoing support for members of support circles will be provided during the 12 weeks immediately after onboarding.
Arm Title
Neurodiversity at Work - Delayed Start (NaW-DS)
Arm Type
Experimental
Arm Description
Participants in this group will receive typical orientation for neurotypical employees after onboarding. The support of peer mentor, job/life skills coach, vocational rehabilitation counselor, and a personal counselor will start 6 months after onboarding. Managers, co-workers, team buddies and mentors for all recruited and hired employees in both groups will receive the same specialized training to enhance their abilities to work with individuals with ASD.
Intervention Type
Behavioral
Intervention Name(s)
NaW
Intervention Description
Participants will receive assistance with finding employment, onboarding, training, and so on.
Intervention Type
Behavioral
Intervention Name(s)
NaW-DS
Intervention Description
Participants will receive assistance with onboarding and training 6 months after the initiation of their employment.
Primary Outcome Measure Information:
Title
Job Retention Rates
Description
Compare job retention rates resulting from NaW starting before onboarding and NaW starting 6 months after onboarding (NaW-DS). The investigators predict that the NaW program will result in a higher rate of sustained employment in adults with ASD 15 months after onboarding when compared to NaW-DS.
Time Frame
Before onboarding for NaW arm; 6 months after onboarding for NaW-DS arm; 15 months after onboarding for both arms.
Title
Duration of Sustained Employment
Description
Compare duration of sustained employment for NaW and NaW-DS. The investigators predict that the NaW program will result in a longer duration of sustained employment as compared to NaW-DS.
Time Frame
15 months after onboarding.
Title
Costs of Employee Turnover
Description
Determine the costs of employee turnover achieved from the NaW and NaW-DS.
Time Frame
15 months after onboarding.
Title
Rates of Job Offers
Description
Compare rates of job offers between internship programs and pre-employment training programs.
Time Frame
15 months after onboarding.
Title
World Health Organization Quality of Life Assessment [WHOQOL-100]
Description
Measures individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. Purpose of measure: compare the change in Quality of Life (QoL) between NaW and NaW-DS for adults with ASD at month 15 post-onboarding; compare the trajectories of change in QoL between NaW and NaW-DS for adults with ASD over time. This scale consists of four domains: physical health, psychological, social relationships, and environment. A higher score indicates a better quality of life, while a lower score indicates a lower quality of life. There is a total of 100 items in this scale. The minimum score is 100, with the highest score being 500. The five point scale ranges from "Not at all" to " Extremely" (or "Completely" or "Very satisfied"). Subscales are combined to produce a total score.
Time Frame
At screening, 3 months after onboarding at job position, 6 months after onboarding, 12 months after onboarding, 15 months after onboarding, 18 months after onboarding.
Secondary Outcome Measure Information:
Title
Maslach's Burnout Measure
Description
Designed to measure burnout as defined by the World Health Organization (WHO). The minimum score is 22, and the maximum score is 132. A lower score indicates lower levels of burnout, while a higher score indicates high levels of burnout. Each item is rated on two scales: a 6-point frequency scale, and a 7-point intensity scale. The frequency scale ranges from "A few times a year" to "Every day." The intensity scale ranges from "Very mild" to "Very strong; major."
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Meyer and Allen's Affective Commitment Measure
Description
The Affective Commitment Scale's items were written to assess affective orientation towards the organization. Some responses are reverse-coded, so higher and lower scores do not necessarily point to similar results across the board. Each item is rated on a 7-point scale, ranging from "Strongly disagree" to "Strongly agree." Scores range from a minimum of 8 to a maximum of 56.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Eisenberger's Perceived Organizational Support
Description
This scale aims to measure perceived organizational support with regard to an individual feeling appreciated, supported, and cared for within their place of work. Some items are reverse-coded. The 7-point scale ranges from "Strongly disagree" to "Strongly agree." Scores range from a minimum of 8 to a maximum of 56.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Morgensen and Humphrey's Job Characteristics (WDQ)
Description
This scale measures work autonomy, task variety, task significance, task identity, and feedback from one's job. It also measures job complexity, information processing, skill variety, and specialization. All items are measured on a 5-point scale, with 1 indicating "Strongly disagree" and 5 being equal to "Strongly agree." Scores range from a minimum of 44 to a maximum of 220. Scores are interpreted in varying ways throughout the instrument.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Judge's Global Job Satisfaction
Description
This scale measures perceived job satisfaction. It consists of 8 individual questions with various response options, including a scale ranging from "Strongly agree" to "Strongly disagree", a "Yes/No" option, a second scale ranging from "Very dissatisfied" to "Very satisfied," and an item in which participants are asked to score their satisfaction by way of percentage allocation. There is no range or minimum/maximum scores in this measure.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
MOAQ Subscale: Intent to Turnover
Description
A 4-item scale with two 7-point scoring scales: "Strongly disagree/Strongly agree" and "Not at all likely/Extremely likely," measuring one's intent to turnover from a job. Scores range from a minimum of 3 to a maximum of 21, with a higher score indicating a higher likelihood of job turnover.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Work Motivation and Engagement (UWES)
Description
A 17-item scale aimed at measuring one's work engagement within a current job. Each item is rated using either one the following 6-point scales: specific (1 = a few times a year or less; 6 = every day) or broad (0 = never; 1 = almost never; 6 = always). Both scales include an option for 'never' (0). The minimum score is 0, with the maximum score being 102. A higher score indicates greater levels of engagement and motivation, with a lower score indicating lower levels of the aforementioned qualities.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
ANZ Financial Well-being Scale
Description
An 11-item scale which measures relative financial comfort and well-being. Items are scored in multiple-choice form as well as three Likert-scale items. Multiple-choice items vary in language but generally aim to measure the degree to which the participant is able to cover necessary expenses and their feelings regarding their financial situation. Some items are reverse-scored, thus making a higher/lower score not necessarily indicative of financial well-being or lack thereof.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Other Pre-specified Outcome Measures:
Title
Rosenberg Scale of Self-Esteem
Description
A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. The minimum score is 10, with the maximum score being 40. A lower score indicates an individuals' lower self-esteem, while a higher score indicates higher levels of self-esteem. The four point scale ranges from "Strongly agree" to "Strongly disagree."
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Social Phobia and Anxiety Inventory
Description
SPAI assesses specific somatic symptoms, cognitions, and behaviors across a wide range of potentially fear-producing situations to measure social anxiety and fear. The scale contains 17 items. The minimum score is 17, and the maximum is 85. A lower scale indicates lower levels of social phobia, while a higher score indicates higher levels of social phobia. The five point scale ranges from "Not at all" to "Extremely."
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Test of Young Adult Social Skills Knowledge
Description
A scale which surveys adolescent and young adult knowledge of social skills and behavioral abnormalities. The scale contains 30 items that are "True/False" and multiple-choice in nature. A lower score (fewer items correct) indicates less knowledge of social skills, while a higher score indicates more knowledge of social skills.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Autism Spectrum Quotient
Description
The Autism Spectrum Quotient was developed by the Autism Research Centre to test if adults with high-functioning autism or Asperger Syndrome are just an extreme on a dimension of autistic traits that runs right through the general population. This scale is comprised of 50 items and the four point scale ranges from "Definitely agree" to "Definitely disagree." Higher and lower scores are irrelevant, as the scales are often reversed within this instrument.
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Title
Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 assesses relative rates of depression amongst human subjects. A higher score indicates a higher level of depression. The scale is comprise of 9 multiple-choice questions and one follow-up multiple-choice question (based on subjects' responses to the previous 9 questions).
Time Frame
Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Moderately functioning group of participants: Males and females with ASD Between the ages of 18-55 No significant current psychosocial stressors per history Able to travel to work independently Attended either an internship program, pre-employment training, or both Possess an IQ between 60 and 90 High functioning group of participants: Males and females with ASD Between the ages of 18-55 No significant current psychosocial stressors per history Able to travel to work independently Attended either an internship program, pre-employment training, or both Possess a college degree Possess an IQ of 90 or above Exclusion criteria: DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lawrence K Fung, MD, PhD
Phone
6504989392
Email
lkfung@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Fung, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Achieving Steady Work Among Adults With Autism Through Specialized Employment Program

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