- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05766280
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
Recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
126
Phase
- 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
- Name: Weili Lu, PhD
- Phone Number: 908-889-2453
- Email: luwe1@shp.rutgers.edu
Study Contact Backup
- Name: Janice Oursler, PhD
- Phone Number: 908-889-2462
- Email: ourslejd@shp.rutgers.edu
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07102
- Recruiting
- Rutgers Univeristy, Newark- Office of Disability Services
-
Contact:
- Lorren Whitaker, PhD
- Phone Number: 973-353-5375
- Email: lorren.whitaker@rutgers.edu
-
-
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
Ages Eligible for Study
16 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Soft Skills Training Intervention via telehealth
|
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
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
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.
Investigators
- 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)
June 23, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
February 16, 2023
First Submitted That Met QC Criteria
March 2, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Mental Health Wellness 1
-
Indiana UniversityCommunity Health Network; Boys & Girls Clubs of IndianapolisCompletedMental Health Wellness 1 | Child Behavior | Adolescent Behavior | Mental Health Wellness 2United States
-
Cedars-Sinai Medical CenterNot yet recruitingMental Health Wellness 1 | Wellness, PsychologicalUnited States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Universiti Putra MalaysiaGreen International UniversityNot yet recruitingMental Health Wellness 1
-
Northern Arizona UniversityUniversity of Colorado, DenverRecruiting
-
The New SchoolColumbia University; Universidad del Norte; HIASRecruitingMental Health Wellness 1Colombia
-
University of Wisconsin, MadisonCompletedMental Health Wellness 1United States
-
University of BathKing's College London; University of Pennsylvania; Newcastle University; University... and other collaboratorsCompletedMental Health Wellness 1United Kingdom
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongCompleted
-
University of South WalesMIND CymruTerminated
Clinical Trials on iCareer Soft Skills Training for Employment
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Kessler FoundationRecruitingTraumatic Brain InjuryUnited States
-
Michigan State UniversityIllinois Institute of TechnologyCompletedAutism Spectrum Disorder | Social Skills | Transition | Confidence, SelfUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH)CompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Major Depression | Anxiety DisorderUnited States
-
Universitas PadjadjaranCompletedAdolescent Mental Health | Bullying Behavior | Emotional Regulation DifficultiesIndonesia
-
Institutt for Psykologisk RadgivningUniversity of Oslo; University of Bergen; The Research Council of NorwayCompletedF01.318 Child Rearing | F01.470 Emotions | F01.145.179 Child BehaviorNorway
-
Universitätsklinikum Hamburg-EppendorfActive, not recruiting
-
VA Office of Research and DevelopmentCompleted
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); Drexel UniversityCompleted
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedDementia | Alzheimer DiseaseUnited States