Autism Spectrum DisorderIMPRESSIVENCT04771338
Examining the Effects of a Job Entry Intervention
A study testing VR-JIT/KF-STRIDE in people with Autism Spectrum Disorder and Autism, run by Kessler Foundation at 1 site in United States.
Trial summary
The current study will examine the efficacy of a virtual reality (VR) intervention as well as a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE) with adolescents diagnosed with autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism, ASD
- What is being tested?
- VR-JIT/KF-STRIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnoses of ASD
- or am a typically developing adolescent
- Able to speak and read English fluently
Who cannot join
- History of stroke, traumatic brain injury, or any other neurological injury or disease
- History of significant psychiatric illness (bipolar, schizophrenia or psychosis)
- Uncontrolled seizures
- Any other unstable medical complications
Trial locations and contacts
1 site in 1 country.
About this study
The current study will examine the efficacy of a virtual reality (VR) intervention as well as a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE) with adolescents diagnosed with autism spectrum disorder.
Read the detailed description
The current study will examine the efficacy of a virtual reality (VR) intervention entitled "IMPRoving Expression of Skills and Strengths In Interviewing in a Virtual Environment" (IMPRESSIVE) which targets social competency skills needed for successful job interviewing. Specifically, 2 VR tools are utilized in the IMPRESSIVE intervention. The first tool is VR-Job Interview Training, a VR program which offers the opportunity for repeated practice with a virtual human interviewer. Preliminary evidence suggests that the VRprogram is successful in adults with ASD and schizophrenia in improving interview abilities. However, the efficacy of it has not been evaluated in adolescents with ASD. This represents a significant void in our knowledge, as we do not know whether this program is effective for youth. In addition to VR training, a newly developed tool is included in the currently proposed intervention: the Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE). KF-STRIDE is focused on improving the ability to express personal strengths during the job interview, a skill that is not taught with VR training. The proposed IMPRESSIVE intervention, which combines the learning of 2 critical abilities (social skills and strength identification), has never been examined in individuals with ASD. Thus, the current proposal will be the first to examine the efficacy of these 2 combined tools in this at-risk population.
- Conditions
- Autism Spectrum Disorder, Autism, ASD
- Being tested
- VR-JIT/KF-STRIDE
- Keywords
- Autism, ASD, Job reentry, Employment intervention, Virtual reality, VR
- 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.
VR-JIT/KF-STRIDEBehavioural
Also called Virtual Interview Training for Transition Age Youth (VIT-TAY), Kessler Foundation STRength IDentification and Expression tool (KF-STRIDE)
Treatment group will receive 12 sessions of job interview training protocol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Job interview training protocol for 12 sessions Receives: Behavioral: VR-JIT/KF-STRIDE |
| Control group | No intervention | No participation in any intervention protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mock Job Interview Change
Mock Job Interview skills will be assessed by having blinded raters trained to assess job interviews scoring participants across a number of domains including expressing personal strengths and sounding professional. This rating scheme has been used in previous research (Smith et al., 2014; 2015),
Measured: 8 weeks
Secondary outcomes (4)
Self-reported job interview skills
Questionnaire to assess self-perceived skills
Measured: 8 weeks
self-reported job interview anxiety
Questionnaire to assess self-perceived anxiety
Measured: 8 weeks
Employment readiness
Questionnaire to assess self-perceived employment readiness
Measured: 8 weeks
Job Search Behavior
Questionnaire to assess self-perceived job search behaviors
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2019
- Primary completion22 Jun 2022
- Study completion26 Jul 2023
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.
- More trials run by Kessler FoundationThe 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
- Single group
- Model description
- Virtual Reality Job Interview Training \& character strength training (KF-STRIDE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Genova, Kessler Foundation
- Investigators
- Helen Genova, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771338
- Sponsor's protocol ID
- R-1078-19
- Acronym
- IMPRESSIVE
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of a Job Entry Intervention
- ClinicalTrials.gov ID
- NCT04771338
- Acronym / sponsor ID
- IMPRESSIVE / R-1078-19
- Conditions
- Autism Spectrum Disorder, Autism, ASD
- Keywords
- Autism, ASD, Job reentry, Employment intervention, Virtual reality, VR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will examine the efficacy of a virtual reality (VR) intervention as well as a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE) with adolescents diagnosed with autism spectrum disorder.
Detailed description
The current study will examine the efficacy of a virtual reality (VR) intervention entitled "IMPRoving Expression of Skills and Strengths In Interviewing in a Virtual Environment" (IMPRESSIVE) which targets social competency skills needed for successful job interviewing. Specifically, 2 VR tools are utilized in the IMPRESSIVE intervention. The first tool is VR-Job Interview Training, a VR program which offers the opportunity for repeated practice with a virtual human interviewer. Preliminary evidence suggests that the VRprogram is successful in adults with ASD and schizophrenia in improving interview abilities. However, the efficacy of it has not been evaluated in adolescents with ASD. This represents a significant void in our knowledge, as we do not know whether this program is effective for youth. In addition to VR training, a newly developed tool is included in the currently proposed intervention: the Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE). KF-STRIDE is focused on improving the ability to express personal strengths during the job interview, a skill that is not taught with VR training. The proposed IMPRESSIVE intervention, which combines the learning of 2 critical abilities (social skills and strength identification), has never been examined in individuals with ASD. Thus, the current proposal will be the first to examine the efficacy of these 2 combined tools in this at-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Virtual Reality Job Interview Training \& character strength training (KF-STRIDE)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: VR-JIT/KF-STRIDEJob interview training protocol for 12 sessions |
| Control group | No intervention | –No participation in any intervention protocol |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnoses of ASD
- or am a typically developing adolescent
- Able to speak and read English fluently
Key exclusion criteria (4 listed)
- History of stroke, traumatic brain injury, or any other neurological injury or disease
- History of significant psychiatric illness (bipolar, schizophrenia or psychosis)
- Uncontrolled seizures
- Any other unstable medical complications
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 |
|---|---|---|
| VR-JIT/KF-STRIDEAlso: Virtual Interview Training for Transition Age Youth (VIT-TAY), Kessler Foundation STRength IDentification and Expression tool (KF-STRIDE)Treatment group will receive 12 sessions of job interview training protocol. | Behavioural | Treatment group |
Primary outcome
Mock Job Interview Change
Time frame: 8 weeks
Mock Job Interview skills will be assessed by having blinded raters trained to assess job interviews scoring participants across a number of domains including expressing personal strengths and sounding professional. This rating scheme has been used in previous research (Smith et al., 2014; 2015),
4 secondary outcomes
Self-reported job interview skills
Time frame: 8 weeks
self-reported job interview anxiety
Time frame: 8 weeks
Employment readiness
Time frame: 8 weeks
Job Search Behavior
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Helen Genova, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-JIT/KF-STRIDE in people with Autism Spectrum Disorder and Autism, run by Kessler Foundation 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 3 inclusion and 4 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mock Job Interview Change (time frame: 8 weeks). 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 17 Jan 2024.