Autism Spectrum DisorderNCT04107064
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
A study testing NaW and NaW-DS in people with Autism Spectrum Disorder and Autism, run by Lawrence Fung at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- NaW and NaW-DS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- NaW, NaW-DS
- Keywords
- Neurodiversity, ASD, Employment, Neurodiverse
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaWBehavioural
Participants will receive assistance with finding employment, onboarding, training, and so on.
NaW-DSBehavioural
Participants will receive assistance with onboarding and training 6 months after the initiation of their employment.
| Study group | Role | What they receive |
|---|---|---|
| Neurodiversity at Work (NaW) Group | Experimental | 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. Receives: Behavioral: NaW |
| Neurodiversity at Work - Delayed Start (NaW-DS) | Experimental | 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. Receives: Behavioral: NaW-DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before onboarding for NaW arm; 6 months after onboarding for NaW-DS arm; 15 months after onboarding for both arms.
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.
Measured: 15 months after onboarding.
Costs of Employee Turnover
Determine the costs of employee turnover achieved from the NaW and NaW-DS.
Measured: 15 months after onboarding.
Rates of Job Offers
Compare rates of job offers between internship programs and pre-employment training programs.
Measured: 15 months after onboarding.
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.
Measured: 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 outcomes (8)
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."
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
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.
Measured: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start30 Sep 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawrence Fung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lawrence Fung, Stanford University
- Investigators
- Lawrence Fung, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107064
- Sponsor's protocol ID
- 50268
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
- ClinicalTrials.gov ID
- NCT04107064
- Acronym / sponsor ID
- 50268
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Neurodiversity, ASD, Employment, Neurodiverse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lawrence FungUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodiversity at Work (NaW) Group | Experimental | Behavioral: NaWIndividuals 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. |
| Neurodiversity at Work - Delayed Start (NaW-DS) | Experimental | Behavioral: NaW-DSParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Moderately functioning group of participants:
- High functioning group of participants:
Key exclusion criteria (1 listed)
- DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or 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 |
|---|---|---|
| NaWParticipants will receive assistance with finding employment, onboarding, training, and so on. | Behavioural | Neurodiversity at Work (NaW) Group |
| NaW-DSParticipants will receive assistance with onboarding and training 6 months after the initiation of their employment. | Behavioural | Neurodiversity at Work - Delayed Start (NaW-DS) |
Primary outcome
Job Retention Rates
Time frame: Before onboarding for NaW arm; 6 months after onboarding for NaW-DS arm; 15 months after onboarding for both arms.
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
Time frame: 15 months after onboarding.
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
Time frame: 15 months after onboarding.
Determine the costs of employee turnover achieved from the NaW and NaW-DS.
Rates of Job Offers
Time frame: 15 months after onboarding.
Compare rates of job offers between internship programs and pre-employment training programs.
World Health Organization Quality of Life Assessment [WHOQOL-100]
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.
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.
8 secondary outcomes
Maslach's Burnout Measure
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Meyer and Allen's Affective Commitment Measure
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Eisenberger's Perceived Organizational Support
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Morgensen and Humphrey's Job Characteristics (WDQ)
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Judge's Global Job Satisfaction
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
MOAQ Subscale: Intent to Turnover
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Work Motivation and Engagement (UWES)
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
ANZ Financial Well-being Scale
Time frame: Baseline, 6 months after onboarding, 12 months after onboarding, and 18 months after onboarding.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Lawrence Fung, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaW and NaW-DS in people with Autism Spectrum Disorder and Autism, run by Lawrence Fung 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 15 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lawrence K Fung, MD, PhD (6504989392, lkfung@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Job Retention Rates (time frame: Before onboarding for NaW arm; 6 months after onboarding for NaW-DS arm; 15 months after onboarding for both arms.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.