NCT04254562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 23, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

January 15, 2020

Last Update Submit

July 19, 2025

Conditions

Keywords

Supported EmploymentSupported EducationMental HealthBehavioral HealthCognitive Remediation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in frequency of educational barriers

    24 months

  • Change in levels of perceived Stress

    24 months

  • Academic Self-Efficacy

    24 months

  • Reliance on Social Security Benefits

    24 months

Study Arms (2)

Experimental Group: HYPE Services

EXPERIMENTAL

The experimental arm will receive the HYPE intervention for 12 months.

Behavioral: Weekly Meetings with a Supported Employment/Supported Education SpecialistBehavioral: Focused Skill and Strategy Training (FSST)

Control Group: Enhanced Academic Services as Usual

ACTIVE COMPARATOR

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

Interventions

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.

Experimental Group: HYPE Services

Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention.

Experimental Group: HYPE Services

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.

Control Group: Enhanced Academic Services as Usual

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

UMass Medical School

Worcester, Massachusetts, 01545, United States

Location

Binghamton University

Binghamton, New York, 13902, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Michelle Mullen, MS

    UMass Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2020

First Posted

February 5, 2020

Study Start

October 11, 2019

Primary Completion

January 30, 2023

Study Completion

September 30, 2024

Last Updated

July 23, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be shared within 3 years of the completion of the study (estimated 2024-2027)
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.

Locations