Mental ImpairmentHYPENCT04254562
Helping Youth on the Path to Employment
A study testing Weekly Meetings with a Supported Employment/Supported Education Specialist, Focused Skill and Strategy Training (FSST) and Enhanced Services as Usual in people with Mental Impairment and Educational Problems, run by University of Massachusetts, Worcester at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Impairment, Educational Problems
- What is being tested?
- Weekly Meetings with a Supported Employment/Supported Education Specialist, Focused Skill and Strategy Training (FSST) and Enhanced Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Oct 2019to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Binghamton University
Binghamton, New York, 13902
Colorado State University
Fort Collins, Colorado, 80523
UMass Medical School
Worcester, Massachusetts, 01545
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Impairment, Educational Problems
- Being tested
- Weekly Meetings with a Supported Employment/Supported Education Specialist, Focused Skill and Strategy Training (FSST), Enhanced Services as Usual
- Keywords
- Supported Employment, Supported Education, Mental Health, Behavioral Health, Cognitive Remediation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Meetings with a Supported Employment/Supported Education SpecialistBehavioural
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)Behavioural
Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention.
Enhanced Services as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: HYPE Services | Experimental | The experimental arm will receive the HYPE intervention for 12 months. Receives: Behavioral: Weekly Meetings with a Supported Employment/Supported Education Specialist; Behavioral: 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." Receives: Behavioral: Enhanced Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start11 Oct 2019
- Primary completion30 Jan 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University, National Institute on Disability, Independent Living, and Rehabilitation Research, Binghamton University
- Responsible party
- Principal investigator, Michelle Mullen, University of Massachusetts, Worcester
- Investigators
- Michelle Mullen, MS, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254562
- Sponsor's protocol ID
- H00017845
- Other IDs
- HHS-2019-ACL-NIDILRR-RTEM-0334
- Acronym
- HYPE
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2020
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Youth on the Path to Employment: Creating Economic Self-sufficiency
- ClinicalTrials.gov ID
- NCT04254562
- Acronym / sponsor ID
- HYPE / H00017845
- Conditions
- Mental Impairment, Educational Problems
- Keywords
- Supported Employment, Supported Education, Mental Health, Behavioral Health, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Colorado State University, National Institute on Disability, Independent Living, and Rehabilitation Research, Binghamton University
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Feb 2020 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: HYPE Services | Experimental | Behavioral: Weekly Meetings with a Supported Employment/Supported Education Specialist, Behavioral: Focused Skill and Strategy Training (FSST)The experimental arm will receive the HYPE intervention for 12 months. |
| Control Group: Enhanced Academic Services as Usual | Active comparator | Behavioral: Enhanced Services as UsualThe 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." |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Weekly Meetings with a Supported Employment/Supported Education SpecialistParticipants 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. | Behavioural | Experimental Group: HYPE Services |
| Focused Skill and Strategy Training (FSST)Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention. | Behavioural | Experimental Group: HYPE Services |
| Enhanced Services as UsualOne hour meetings every semester to review individual academic needs and review list of available on campus resources to best meet the student's needs. | Behavioural | Control Group: Enhanced Academic Services as Usual |
Primary outcome
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
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
4 secondary outcomes
Change in frequency of educational barriers
Time frame: 24 months
Change in levels of perceived Stress
Time frame: 24 months
Academic Self-Efficacy
Time frame: 24 months
Reliance on Social Security Benefits
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Michelle Mullen, MS principal investigator
UMass Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Meetings with a Supported Employment/Supported Education Specialist, Focused Skill and Strategy Training (FSST) and Enhanced Services as Usual in people with Mental Impairment and Educational Problems, run by University of Massachusetts, Worcester at 3 sites 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of students making satisfactory academic progress (time frame: 24 months). The study lists 2 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 23 Jul 2025.