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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04254562
Other study ID # H00017845
Secondary ID HHS-2019-ACL-NID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 11, 2019
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Helping Youth on the Path to Employment (HYPE): Creating economic self-sufficiency, a randomized-controlled implementation efficacy hybrid trial, will test a manualized intervention combining educational and employment supports for young adults with mental health conditions on a college campus.


Description:

Previous controlled trials in mature adult subjects has consistently demonstrated that Supported Employment interventions (i.e., Individual Placement and Supports) elicit benefit for those with mental health conditions in getting and keeping productive work. Similarly, previous research demonstrates that Supported Education has efficacy in helping young adults with mental health conditions in their academics. However, to date, no evidence-based practice exists which combines both supported education and supported employment interventions into a single model that has efficacy and utility for young adults with serious mental health conditions. Supported Education has been fruitful for navigating academics, but hasn't demonstrated efficacy for supporting young adults with their careers, and Supported Employment programs, like IPS, have shown poor efficacy for helping young adults, as it was designed to assist mature adults. Therefore, the HYPE Model will become the first evidence-informed intervention to combine Supported Employment and Supported Education paradigms in an effort to help young adults with mental health conditions successfully navigate college so they can move into a primary labor market career and attain economic self-sufficiency. Furthermore, this study will be employed from within the university setting itself, on the college campus, and will be embedded directly in either Services for Students with Disabilities (SSD) (i.e., Office of disability services) or Office of Counseling Services.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 103
Est. completion date September 30, 2024
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - be between 18-30 years of age - able to speak and read English fluently - cognitively capable of providing informed consent and participating in study activities; - enrolled in a minimum of six credits at a campus-based accredited college (two year or four-year programs) - intending to enroll in a minimum of four semesters of college courses with the expectation of being continuously enrolled - have had at least one prior academic disruption during a college academic semester - (e.g., withdrawal from postsecondary institutions; academic probation; not meeting satisfactory academic progress; or a prior leave of absence) prior to study enrollment - currently have a diagnosed mental health condition by a licensed mental health provider under the DSM-V Axis 1 diagnoses (schizophrenia or other psychotic disorders, anxiety disorders, mood disorders, eating disorders, attention deficits and disruptive behavior disorders) or have been deemed eligible for ADA protections due to a disabling mental health condition - (e.g., receiving state vocational agency services, SSI/DI benefits, or postsecondary accommodations). Exclusion Criteria: - have received or are receiving supports consistent with HYPE in the past year; - have had no impact to academic success in college (i.e. disruption); - have a secondary autism spectrum disorder, traumatic brain injury, or other neurodevelopmental or neurocognitive disorder affecting cognition; - are currently incarcerated prisoners; - are unable to speak or read English fluently; - are under age 18 or require a legal guardian to provide informed consent; - lack the cognitive capability to provide informed consent on their own

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Weekly Meetings with a Supported Employment/Supported Education Specialist
Participants will receive intervention for 12 months which includes weekly meetings with a Supported Employment/Supported Education Specialist (HYPE Specialist). During the weekly meetings, the HYPE Specialist will review each participant's education and employment goals, and deliver individualized support relevant to those goals which include use of structured HYPE tools and worksheets as needed.
Focused Skill and Strategy Training (FSST)
Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention.
Enhanced Services as Usual
One hour meetings every semester to review individual academic needs and review list of available on campus resources to best meet the student's needs.

Locations

Country Name City State
United States Binghamton University Binghamton New York
United States Colorado State University Fort Collins Colorado
United States UMass Medical School Worcester Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
University of Massachusetts, Worcester Binghamton University, Colorado State University, National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of students making satisfactory academic progress Number of students making satisfactory academic progress (SAP), defined as a student completing two-thirds of the courses they enroll in each semester and achieving a GPA of 2.0 or greater 24 months
Primary Number of students with disruptions toward completion of college degree. Number of students with disruptions toward completion of college degree, defined as withdrawal from postsecondary institutions, academic probation, not meeting satisfactory academic progress, or a leave of absence 24 months
Secondary Change in frequency of educational barriers The average frequency of educational barriers experienced by participants, defined as the specific challenges participants face in their pursuit of postsecondary education and whether and how their use of accommodations through campus disability services has or would be helpful for them. This will be measured with the Educational Barriers Questionnaire. 24 months
Secondary Change in levels of perceived Stress Change in levels of perceived stress throughout the study in the experimental condition, measured by the perceived stress scale. 24 months
Secondary Academic Self-Efficacy Changes in academic self-efficacy among students across the study will be measured with the college self-efficacy scale and is defined as assess the degree to which participants' feel confident in their ability to complete tasks in college 24 months
Secondary Reliance on Social Security Benefits Changes on students' reliance on Social Security benefits will be measured via self-report on the Baseline and Follow-up Demographics surveys 24 months
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