Mental Health Wellness 1iCareerNCT05766280
Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions
A study testing iCareer Soft Skills Training for Employment in people with Mental Health Wellness 1 and Mental Health Wellness 2, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Mental Health Wellness 2, Occupational Problems
- What is being tested?
- iCareer Soft Skills Training for Employment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Univeristy, Newark- Office of Disability Services
Newark, New Jersey, 07102
Lorren Whitaker, PhD, 973-353-5375, lorren.whitaker@rutgers.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- iCareer Soft Skills Training for Employment
- Keywords
- transition age youth, mental health conditions, employment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCareer Soft Skills Training for EmploymentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Soft Skills Training Intervention via telehealth Receives: Behavioral: iCareer Soft Skills Training for Employment |
| Control | No intervention | Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months post intervention
Secondary outcomes (6)
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)
Measured: 12 months post intervention
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).
Measured: 12 months post intervention
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).
Measured: 12 months post intervention
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).
Measured: 12 months post intervention
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).
Measured: 12 months post intervention
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).
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start23 Jun 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weili Lu, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Weili Lu, PhD, Principal investigator, Rutgers University, School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766280
- Sponsor's protocol ID
- 2022001761
- Other IDs
- 90IFRE0071
- Acronym
- iCareer
- Status last verified
- Nov 2024
- First submitted
- 16 Feb 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Assisted Career-Oriented Soft-skills Training (iCareer) for Transition Age Youth with Mental Health Conditions: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05766280
- Acronym / sponsor ID
- iCareer / 2022001761
- Keywords
- transition age youth, mental health conditions, employment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: iCareer Soft Skills Training for EmploymentSoft Skills Training Intervention via telehealth |
| Control | No intervention | –Treatment as Usual (TAU) |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCareer Soft Skills Training for EmploymentThe 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. | Behavioural | Treatment |
Primary outcome
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.
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.
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.
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).
6 secondary outcomes
Reduced Depressive Symptoms
Time frame: 12 months post intervention
Improved Functional Status
Time frame: 12 months post intervention
Reduced Mental Illness Stigma
Time frame: 12 months post intervention
Increased Work Empowerment
Time frame: 12 months post intervention
Increased Job Satisfaction
Time frame: 12 months post intervention
Increased Job Motivation
Time frame: 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weili Lu, PhD principal investigator
Rutgers University, School of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCareer Soft Skills Training for Employment in people with Mental Health Wellness 1 and Mental Health Wellness 2, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Lu, PhD (908-889-2453, luwe1@shp.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher Rates of Employment (time frame: 12 months post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.