Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions (iCareer)

November 12, 2024 updated by: Weili Lu, Ph.D., Rutgers, The State University of New Jersey

Internet Assisted Career-Oriented Soft-skills Training (iCareer) for Transition Age Youth with Mental Health Conditions: a Randomized Controlled Trial

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.

Study Overview

Status

Status

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

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.

Detailed Description

The investigators propose to perform an open trial research study directed toward producing new knowledge about the Direct Skills Teaching intervention for employment related interpersonal "soft" skills. Soft skills are generally defined as social, emotional, interpersonal, adaptive, and problem-solving skills (Grugulis et al., 2009). The investigators will examine the feasibility of integrated Direct Skills Training modules in social, emotional, interpersonal, adaptive, and problem-solving skills (Soft Skills at Work (SSW)) on improving employment participation and success among transition age youth and young adults (TAY) with disabilities ages 18-24.

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 (Estimated)

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.
126

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Recruiting
        • Rutgers Univeristy, Newark- Office of Disability Services
        • Contact:

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 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Factorial 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: Treatment
Soft Skills Training Intervention via telehealth
Behavioral: iCareer Soft Skills Training for Employment
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.
No Intervention: Control
Treatment as Usual (TAU)

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
Higher Rates of Employment
Time Frame: 12 months post intervention
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
Time Frame: 12 months post intervention
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
Time Frame: 12 months post intervention
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
Time Frame: 12 months post intervention
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 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
Reduced Depressive Symptoms
Time Frame: 12 months post intervention
Participants in iCareer will report less depression and overall symptoms than participants in TAU services alone as evidenced by lower scores on the Patient Health Questionnaire-9 (PHQ-9; Kroeneke et al., 2001)
12 months post intervention
Improved Functional Status
Time Frame: 12 months post intervention
Participants in iCareer will report improved functional status related to their disability than participants in TAU alone as evidenced by lower scores on the Sheehan Disability Scale (Sheehan,1983) and lower scores on the BASIS-32 (Eisen et al., 1994).
12 months post intervention
Reduced Mental Illness Stigma
Time Frame: 12 months post intervention
Participants in iCareer will report less stigma related to mental illness than participants in TAU alone as evidenced by lower scores on the Brief Version of the Internalized Stigma of Mental Illness Scale (ISMI-10; Boyd et al., 2014).
12 months post intervention
Increased Work Empowerment
Time Frame: 12 months post intervention
Participants in iCareer will report increased work empowerment compared to participants in TAU services alone as evidenced by higher scores on the Work Related Self-Efficacy Scale (WSS; Waghorn et al., 2005).
12 months post intervention
Increased Job Satisfaction
Time Frame: 12 months post intervention
Participants in iCareer will report increased job satisfaction compared to participants in TAU services alone as evidenced by higher scores on the Occupational Self-Efficacy Scale- Short Form (OSES; Schyns & von Collani, 2002).
12 months post intervention
Increased Job Motivation
Time Frame: 12 months post intervention
Participants in iCareer will report increased motivation to get employment compared to participants in TAU services alone as evidenced by lower scores on the Perceived Employment Barriers Survey (PEBS; Hong et al., 2014) and higher scores on the Short Employment Hope Scale (Hong &Choi, 2013).
12 months post intervention

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.
Rutgers, The State University of New Jersey

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: Weili Lu, PhD, Rutgers University, School of Health Professions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
June 23, 2023

Primary Completion (Estimated)

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.
March 1, 2027

Study Completion (Estimated)

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.
March 1, 2027

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).
February 16, 2023

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.
March 2, 2023

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.
March 13, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
November 14, 2024

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.
November 12, 2024

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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 2022001761
  • 90IFRE0071 (Other Grant/Funding Number: DHHS: Administration for Community Living)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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