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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05766280
Other study ID # 2022001761
Secondary ID 90IFRE0071
Status Recruiting
Phase N/A
First received
Last updated
Start date June 23, 2023
Est. completion date March 1, 2027

Study information

Verified date July 2023
Source Rutgers, The State University of New Jersey
Contact Weili Lu, PhD
Phone 908-889-2453
Email luwe1@shp.rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date March 1, 2027
Est. primary completion date March 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Rutgers Univeristy, Newark- Office of Disability Services Newark New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Reduced Depressive Symptoms 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
Secondary Improved Functional Status 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
Secondary Reduced Mental Illness Stigma 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
Secondary Increased Work Empowerment 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
Secondary Increased Job Satisfaction 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
Secondary Increased Job Motivation 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
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