NCT05766280

Brief Summary

The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jun 2023Mar 2027

First Submitted

Initial submission to the registry

February 16, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

February 16, 2023

Last Update Submit

November 12, 2024

Conditions

Mental Health Wellness 1Mental Health Wellness 2Occupational Problems

Keywords

transition age youthmental health conditionsemployment

Outcome Measures

Primary Outcomes (4)

  • Higher Rates of Employment

    Participants in iCareer will have higher rates of employment than participants in TAU alone as evidenced by self-report of acquiring a job.

    12 months post intervention

  • Higher Number of Hours Worked

    Participants in iCareer will have higher numbers hours worked than particiapants in TAU alone as evidenced by self-report of hours worked.

    12 months post intervention

  • Increased Wages Earned

    Participants in iCareer will have higher wages earned than participants in TAU alone as evidenced by self-report of wages earned.

    12 months post intervention

  • Improved Job Related Social Skills

    Participants in iCareer will have better job-related social skills than in TAU alone as evidenced by higher scores on the Job Related Social Skills Checklist (Reganick, 1995).

    12 months post intervention

Secondary Outcomes (6)

  • Reduced Depressive Symptoms

    12 months post intervention

  • Improved Functional Status

    12 months post intervention

  • Reduced Mental Illness Stigma

    12 months post intervention

  • Increased Work Empowerment

    12 months post intervention

  • Increased Job Satisfaction

    12 months post intervention

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Soft Skills Training Intervention via telehealth

Behavioral: iCareer Soft Skills Training for Employment

Control

NO INTERVENTION

Treatment as Usual (TAU)

Interventions

iCareer Soft Skills Training for EmploymentBEHAVIORAL

The telehealth iCareer intervention will be delivered during regular educational or vocational services (i.e., services from the Office of Disability Services (ODS) and/or from the school or college counseling center). Six modules of Soft Skills Training (SST), four group sessions for each module with 60 to 90 min for each session (depending on group size) will be delivered by trained project staff (graduate counseling student assistant or graduate counseling intern) via HIPAA-compliant Zoom videoconferencing. If participants are unable to join by Zoom videoconferencing, telephone (a format widely used in Cognitive Behavior Therapy (CBT) for Post Traumatic Stress Disorder (PTSD) treatment delivery and in CBT for depression) will be utilized. Ethical guidelines for providing telehealth over videoconferencing or phone will be followed.

Treatment

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 16 and 24 years
  • Must speak English fluently
  • Receiving Individualized Education Program (IEP)/504 Plan or disability services within the past 24 months with primary disability types of psychiatric disability
  • No hospitalizations or suicide attempts within the past 2 months
  • Willing to provide informed consent (if younger than 18, parental consent) to participate in the study
  • Interested in improving work-related social skills

You may not qualify if:

  • Current presence of neurological disease or brain injury
  • Psychiatric instability such as gross psychosis or acute suicidality
  • Current alcohol or substance dependence
  • Hospitalization or suicide attempts in the past 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Univeristy, Newark- Office of Disability Services

Newark, New Jersey, 07102, United States

RECRUITING

MeSH Terms

Interventions

Employment

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Weili Lu, PhD

    Rutgers University, School of Health Professions

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Lu, PhD

CONTACT

908-889-2453luwe1@shp.rutgers.edu

Janice Oursler, PhD

CONTACT

908-889-2462ourslejd@shp.rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will not be providing the intervention
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 13, 2023

Study Start

June 23, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Secondary use of data may be available to researchers after the completion of the study, provided through de-identified data deposited to the data repository, Interuniversity Consortium for Political and Social Research (ICPSR) as part of the grant award agreement required by the funding agency, the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). The ICPSR will further ensure that the data will in no way contain any identifying information for participants.

Time Frame
Secondary use of data may be available to researchers after the completion of the study, provided through de-identified data deposited to the data repository, Interuniversity Consortium for Political and Social Research (ICPSR) as part of the grant award agreement required by the funding agency, the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). The ICPSR will further ensure that the data will in no way contain any identifying information for participants.
Access Criteria
Secondary use of data may be available to researchers after the completion of the study, provided through de-identified data deposited to the data repository, Interuniversity Consortium for Political and Social Research (ICPSR) as part of the grant award agreement required by the funding agency, the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). The ICPSR will further ensure that the data will in no way contain any identifying information for participants.

Locations

US(1)