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Helping Youth on the Path to Employment (HYPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254562
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Colorado State University
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Michelle Mullen, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Mental Impairment Educational Problems Behavioral: Weekly Meetings with a Supported Employment/Supported Education Specialist Behavioral: Focused Skill and Strategy Training (FSST) Behavioral: Enhanced Services as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Research/Recruitment Specialist, responsible for data collection, will be blinded to the treatment conditions and will not know which participants are allocated to which condition. All data collection personnel and evaluators will be blinded. Thus, HYPE is a single-blind randomized trial.
Primary Purpose: Other
Official Title: Helping Youth on the Path to Employment: Creating Economic Self-sufficiency
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : September 23, 2021
Estimated Study Completion Date : September 23, 2023

Arm Intervention/treatment
Experimental: Experimental Group: HYPE Services
The experimental arm will be receiving the HYPE intervention for 12 months and followed for an additional 24 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
The control arm will receive a special personalized packet of resources available on campus 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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254562


Contacts
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Contact: Michelle Mullen, MS 508-856-2865 michelle.mullen@umassmed.edu
Contact: Amanda Costa, BS 508-856-2865 amanda.costa@umassmed.edu

Locations
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United States, Colorado
Colorado State University Recruiting
Fort Collins, Colorado, United States, 80523
Contact: James E Graham, PhD    970-491-1356    je.graham@colostate.edu   
Sub-Investigator: James E Graham, PhD         
United States, Massachusetts
UMass Medical School Recruiting
Worcester, Massachusetts, United States, 01545
Contact: Amanda Costa, BA    508-856-2865    amanda.costa@umassmed.edu   
Principal Investigator: Michelle Mullen, MS         
Sponsors and Collaborators
University of Massachusetts, Worcester
Colorado State University
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Michelle Mullen, MS UMass Medical School

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Responsible Party: Michelle Mullen, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04254562    
Other Study ID Numbers: H00017845
HHS-2019-ACL-NIDILRR-RTEM-0334 ( Other Grant/Funding Number: NIDILRR )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Mullen, University of Massachusetts, Worcester:
Supported Employment
Supported Education
Mental Health
Behavioral Health
Cognitive Remediation