Modifying (Phase I) and Evaluating (Phase II) Virtual Reality Job Interview Training for Youth in Transition

June 19, 2023 updated by: Matthew Smith, University of Michigan
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-1106
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 16-26 years old and enrolled in high school or post-high school transition programming;
  2. 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;
  3. Fluency in English with at least a 3rd grade reading level (confirmed with the Wide Range Achievement Test);
  4. Currently receiving transitional services as specified in IEP or other;
  5. Willing to be video-recorded; and
  6. Willing and able to provide informed consent.

Exclusion Criteria:

  1. Has an uncorrected hearing or visual problem that prevents him or her from using the training.
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Services as usual + Virtual Reality Job Interview Training
In addition to the services as usual comparator, participants will participate in Virtual Reality Job Interview Training.
Behavioral: Virtual Reality Job Interview Training
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.
Behavioral: Services as Usual
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.
Active Comparator: Services as Usual
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.
Behavioral: Services as Usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Job Interview Self-Efficacy
Time Frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment)
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.
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)
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.
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
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.
Collected at pre-test and at 6 months after completing Post-Test Visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms
Time Frame: Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment).
Participants self-reported level of depressive symptoms at pre-test and post-test using the brief version of the Mood and Feelings Questionnaire (b-MFQ; Angold et al., 1995). The measure include 13 items on a scale of 0 to 2, with a total range of 0 to 26. Scores of 12 or greater suggest clinical depression, so higher scores indicate higher depressive symptoms, which is a negative outcome.
Collected at Pre-Test and Post-Test visits (within approximately 1 month of active treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of Wisconsin, Madison
SIMmersion, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Smith, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00129575
  • 5R34MH111531-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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