Autism Spectrum DisorderNCT03514134
Modifying (Phase I) and Evaluating (Phase II) Virtual Reality Job Interview Training for Youth in Transition
A study testing Virtual Reality Job Interview Training and Services as Usual in people with Autism Spectrum Disorder, run by University of Michigan at 1 site in United States.
Trial summary
The unemployment rate is quite high among adults with an autism spectrum disorder (ASD). Inadequate transition planning during high school and gaps between vocational needs and availability of evidence-based services help explain the struggles of transition-age youth at obtaining employment. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual Reality Job Interview Training and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-26 years old and enrolled in high school or post-high school transition programming;
- Educational Diagnosis of autism spectrum disorder using the Social Responsivity Scale 2nd Edition28, or a diagnosis of cognitive impairment, emotional disability, educational impairment or other health impairment according to the students Individualized Education Plan (IEP). They may have diagnosis of autism spectrum disorder as indicated in their IEP/school plan, or as indicated by a parent;
- Fluency in English with at least a 3rd grade reading level (confirmed with the Wide Range Achievement Test);
- Currently receiving transitional services as specified in IEP or other;
- Willing to be video-recorded; and
- Willing and able to provide informed consent.
Who cannot join
- Has an uncorrected hearing or visual problem that prevents him or her from using the training.
- Has a medical illness that compromises their cognition (for example, moderate to severe traumatic brain injury)
- Inclusion and exclusion criteria is subject to PI discretion. Some students may still be enrolled after discussion with the teacher if it is determined that they still might be able to participate despite matching exclusion criteria, or not meeting all of the inclusion criteria. These cases will be documented and reported to IRB.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-1106
About this study
The unemployment rate is quite high among adults with an autism spectrum disorder (ASD). Inadequate transition planning during high school and gaps between vocational needs and availability of evidence-based services help explain the struggles of transition-age youth at obtaining employment. There is a paucity of research on developing and evaluating services to support the transition to the work force after graduating from high school. The lack of available resources to support transition-age youth with an ASD speaks to the need to develop interventions that ameliorate obstacles to employment and help support the transition to the work force. Due to the social deficits characterizing ASD innovative interventions could target preparing job interview skills for students facing the transition to employment as the job interview is a critical gateway to securing a job offer. Thus, the overarching goal of this study is to modify an existing virtual reality job interview skills training program for use in high school students with ASD and to test the feasibility and effectiveness of conducting this intervention in a high school setting via a small controlled trial. Thus, study's first aim is to modify the existing 'Virtual Reality Job Interview Training' program to meet the specific needs of high school seniors with ASD. This will accomplish this by conducting in depth interviews with high school students with ASD and their vocational counselors to solicit feedback to modify the current training's learning goals, content, usability, and simulated interview scripts to meet the specific needs of transition age youth. An expert panel will determine the final modifications to the training program based on the results of the qualitative data analysis and their own views of the program. Second aim of the study is to conduct a pilot trial to evaluate the feasibility, acceptability, portability, fidelity and preliminary effectiveness of the modified intervention in a randomized controlled trial. This study will also explore potential mechanisms for effectiveness and collect pilot implementation data.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual Reality Job Interview Training, Services as Usual
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Job Interview TrainingBehavioural
Students will engage in didactic training related to strategies to perform well during a job interview as well as repeated practice with a virtual hiring manager. Throughout and after completion of the virtual interviews, participants will receive feedback on their performance.
Services as UsualBehavioural
Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training.
| Study group | Role | What they receive |
|---|---|---|
| Services as usual + Virtual Reality Job Interview Training | Experimental | In addition to the services as usual comparator, participants will participate in Virtual Reality Job Interview Training. Receives: Behavioral: Virtual Reality Job Interview Training; Behavioral: Services as Usual |
| Services as Usual | Active comparator | Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Job Interview Skills
Interviewing skills will be measured using a role-play measure in which subjects act out one job interview scenario with trained actors. Interviews will be video recorded and scored. There is one mock interview and pre-test and one mock interview at post-test. The method of assessment is the job interview skills rating scale as measured by the Mock Interview Rating Scale, which has 14 items with each item ranging from 1 (Unlikely) to 7 (Very Likely). Possible scores range from 14 to 98, with higher scores indicating better interview skills.
Measured: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Secondary outcomes (3)
Job Interview Self-Efficacy
9 item self-report consisting of 11 items on a 5-point Likert-type scale, with 1 indicating "Not at all" and 5 indicating "Very True". The range of scores is from 11 to 55, with higher scores indicating more self-efficacy/motivation to complete job interviews, which is a better outcome.
Measured: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Change in Job Interview Anxiety
15 item self-report using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA; McCroskey, 1970). After reviewing the brief PRSPA, we selected and reframed 10 items using a three point Likert-type scale (0 = "not at all," 1 = "sometimes," and 2 = "often"). Higher scores indicated higher anxiety, and scores could range from 0 to 26.
Measured: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Competitive Employment
Obtained a part-time or full-time community-based job as completed via a self-report measure yes/no question. This survey could have been completed by either participants themselves, parents, or teachers.
Measured: Collected at pre-test and at 6 months after completing Post-Test Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Oct 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, SIMmersion, LLC, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Matthew Smith, University of Michigan
- Investigators
- Matthew Smith, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514134
- Sponsor's protocol ID
- HUM00129575
- Other IDs
- 5R34MH111531-03
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2018
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying (Phase I) and Evaluating (Phase II) Virtual Reality Job Interview Training for Youth in Transition
- ClinicalTrials.gov ID
- NCT03514134
- Acronym / sponsor ID
- HUM00129575
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, SIMmersion, LLC, National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The unemployment rate is quite high among adults with an autism spectrum disorder (ASD). Inadequate transition planning during high school and gaps between vocational needs and availability of evidence-based services help explain the struggles of transition-age youth at obtaining employment. There is a paucity of research on developing and evaluating services to support the transition to the work force after graduating from high school. The lack of available resources to support transition-age youth with an ASD speaks to the need to develop interventions that ameliorate obstacles to employment and help support the transition to the work force. Due to the social deficits characterizing ASD innovative interventions could target preparing job interview skills for students facing the transition to employment as the job interview is a critical gateway to securing a job offer. Thus, the overarching goal of this study is to modify an existing virtual reality job interview skills training program for use in high school students with ASD and to test the feasibility and effectiveness of conducting this intervention in a high school setting via a small controlled trial. Thus, study's first aim is to modify the existing 'Virtual Reality Job Interview Training' program to meet the specific needs of high school seniors with ASD. This will accomplish this by conducting in depth interviews with high school students with ASD and their vocational counselors to solicit feedback to modify the current training's learning goals, content, usability, and simulated interview scripts to meet the specific needs of transition age youth. An expert panel will determine the final modifications to the training program based on the results of the qualitative data analysis and their own views of the program. Second aim of the study is to conduct a pilot trial to evaluate the feasibility, acceptability, portability, fidelity and preliminary effectiveness of the modified intervention in a randomized controlled trial. This study will also explore potential mechanisms for effectiveness and collect pilot implementation data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Services as usual + Virtual Reality Job Interview Training | Experimental | Behavioral: Virtual Reality Job Interview Training, Behavioral: Services as UsualIn addition to the services as usual comparator, participants will participate in Virtual Reality Job Interview Training. |
| Services as Usual | Active comparator | Behavioral: Services as UsualStudy participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 16-26 years old and enrolled in high school or post-high school transition programming;
- Educational Diagnosis of autism spectrum disorder using the Social Responsivity Scale 2nd Edition28, or a diagnosis of cognitive impairment, emotional disability, educational impairment or other health impairment according to the students Individualized Education Plan (IEP). They may have diagnosis of autism spectrum disorder as indicated in their IEP/school plan, or as indicated by a parent;
- Fluency in English with at least a 3rd grade reading level (confirmed with the Wide Range Achievement Test);
- Currently receiving transitional services as specified in IEP or other;
- Willing to be video-recorded; and
Key exclusion criteria (3 listed)
- Has an uncorrected hearing or visual problem that prevents him or her from using the training.
- Has a medical illness that compromises their cognition (for example, moderate to severe traumatic brain injury)
- Inclusion and exclusion criteria is subject to PI discretion. Some students may still be enrolled after discussion with the teacher if it is determined that they still might be able to participate despite matching exclusion criteria, or not meeting all of the inclusion criteria. These cases will be documented and reported to IRB.
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 |
|---|---|---|
| Virtual Reality Job Interview TrainingStudents will engage in didactic training related to strategies to perform well during a job interview as well as repeated practice with a virtual hiring manager. Throughout and after completion of the virtual interviews, participants will receive feedback on their performance. | Behavioural | Services as usual + Virtual Reality Job Interview Training |
| Services as UsualStudy participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. | Behavioural | Services as Usual, Services as usual + Virtual Reality Job Interview Training |
Primary outcome
Change in Job Interview Skills
Time frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Interviewing skills will be measured using a role-play measure in which subjects act out one job interview scenario with trained actors. Interviews will be video recorded and scored. There is one mock interview and pre-test and one mock interview at post-test. The method of assessment is the job interview skills rating scale as measured by the Mock Interview Rating Scale, which has 14 items with each item ranging from 1 (Unlikely) to 7 (Very Likely). Possible scores range from 14 to 98, with higher scores indicating better interview skills.
3 secondary outcomes
Job Interview Self-Efficacy
Time frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Change in Job Interview Anxiety
Time frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
Competitive Employment
Time frame: Collected at pre-test and at 6 months after completing Post-Test Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Matthew Smith, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Job Interview Training and Services as Usual in people with Autism Spectrum Disorder, run by University of Michigan 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 6 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 22 Jun 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Job Interview Skills (time frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)). 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 22 Jun 2023.