Helping Youth on the Path to Employment (HYPE)

July 19, 2025 updated by: Michelle Mullen, University of Massachusetts, Worcester

Helping Youth on the Path to Employment: Creating Economic Self-sufficiency

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.

Study Overview

Status

Status

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

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

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.

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 (Actual)

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.
103

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
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University
    • Massachusetts
      • Worcester, Massachusetts, United States, 01545
        • UMass Medical School
    • New York
      • Binghamton, New York, United States, 13902
        • Binghamton University

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Experimental Group: HYPE Services
The experimental arm will receive the HYPE intervention for 12 months.
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.
Behavioral: Focused Skill and Strategy Training (FSST)
Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention.
Active Comparator: Control Group: Enhanced Academic Services as Usual
The control arm will receive a special personalized packet of resources available on campus and off-campus within a 10-mile radius, as "enhanced academic services as usual."
Behavioral: 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.

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
Number of students making satisfactory academic progress
Time Frame: 24 months
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
Number of students with disruptions toward completion of college degree.
Time Frame: 24 months
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 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
Change in frequency of educational barriers
Time Frame: 24 months
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
Change in levels of perceived Stress
Time Frame: 24 months
Change in levels of perceived stress throughout the study in the experimental condition, measured by the perceived stress scale.
24 months
Academic Self-Efficacy
Time Frame: 24 months
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
Reliance on Social Security Benefits
Time Frame: 24 months
Changes on students' reliance on Social Security benefits will be measured via self-report on the Baseline and Follow-up Demographics surveys
24 months

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.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Binghamton University
National Institute on Disability, Independent Living, and Rehabilitation Research
Colorado State University

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: Michelle Mullen, MS, UMass Medical School

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.
October 11, 2019

Primary Completion (Actual)

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.
January 30, 2023

Study Completion (Actual)

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.
September 30, 2024

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).
January 15, 2020

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.
January 31, 2020

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.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

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.
July 23, 2025

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.
July 19, 2025

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.
March 1, 2025

More Information

Terms related to this study

Keywords

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.
  • H00017845
  • HHS-2019-ACL-NIDILRR-RTEM-0334 (Other Grant/Funding Number: NIDILRR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, individual deidentified participant data will be shared to ICPSR per funder (NIDILRR) regulations. Datasets will include: screening data (eligible participants only), baseline data, follow-up time 1 data, follow-up time 2 data, follow-up time 3 data, transcript data. Each dataset will share the same unique identifier (study ID) as well as date the data was collected. Codebooks (PDF format) and data dictionaries (CSV or TXT) will also be shared.

IPD Sharing Time Frame

Data will be shared within 3 years of the completion of the study (estimated 2024-2027)

IPD Sharing Access Criteria

If individuals outside of the study team (e.g. grad students) want data access they need to submit a formal request and if approved, be added to the IRB protocol & complete all necessary human subjects research certifications. They will be required to sign data use agreements. Any external researchers must sign a user agreement form before obtaining data. Data resulting from this project will be distributed at no cost. The user agreement is a UMMS requirement and this procedure is similar to those used by similar projects. The user agreement includes a detailed description of limitations on the redistribution/use of the data. External users are also required to limit publications to topics indicated in the agreement. Publications resulting from using data will reference the source as provided in agreement form; recommended citations will be provided. An investigator/Project Director will monitor dataset use to ensure data are handled properly and utilized for original purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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