Examining the Effects of a Job Entry Intervention | NCT04771338

Studies
Examining the Effects of a Job Entry Intervention

NCT04771338

Sponsor

Kessler Foundation

Status

Completed

Last Update Posted

Jan 17, 2024Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Autism Spectrum Disorder
Autism
ASD

Interventions

VR-JIT/KF-STRIDE

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Jun 22, 2022Actual

Completion Date

Jul 26, 2023Actual

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2024

Last Update Posted Date

Jan 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helen Genova, Associate Director, Center for Autism Research, Kessler FoundationPrincipal Investigator

Lead Sponsor

Kessler FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Job interview training protocol for 12 sessions	Behavioral: VR-JIT/KF-STRIDE
Control group	No Intervention	No participation in any intervention protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VR-JIT/KF-STRIDE	Behavioral	Treatment group will receive 12 sessions of job interview training protocol.	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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),	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Self-reported job interview skills	Questionnaire to assess self-perceived skills	8 weeks
self-reported job interview anxiety	Questionnaire to assess self-perceived anxiety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnoses of ASD
or am a typically developing adolescent
Able to speak and read English fluently

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helen Genova, PhD	Kessler Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kessler Foundation		East Hanover	New Jersey	07936	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided