Pilot Evaluation of Digital Peer-Support Intervention for College Students

May 1, 2026 updated by: Yale University

Pilot Evaluation of College Peer-Support Intervention to Increase Mental Health Literacy and Skills

This pilot study aims to explore the feasibility, acceptability, usability, and preliminary efficacy of the Be There Certificate (BTC) program, a digital mental health literacy and peer support intervention among college students living in shared housing. This study addresses the growing need for scalable, skills-based mental health interventions that empower young adults to support one another in their everyday environments. In particular, the study seeks to understand whether students can complete and engage with the BTC content and how they apply these skills in real-life peer interactions. Through quantitative and qualitative methods, the study will examine changes in mental health knowledge, attitudes, and peer-support behaviors among students who complete the BTC program, and explore the lived experiences of those who provided and those who received support post-intervention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will use a mixed-methods, cluster-randomized, waitlist-controlled pilot trial design. Shared college housing units will be randomized to either the intervention arm, which will immediately complete the BTC program, or to a waitlist control arm, which will receive BTC access after the final study follow-up. Quantitative data will be collected through surveys administered at baseline, 2 weeks, and 12 weeks post-intervention. The Intervention group will also complete a post-training survey. These surveys will assess constructs such as self-efficacy, peer support behaviors, help-seeking attitudes, and mental health literacy, as aligned with the program's logic model.

To complement the quantitative data, the study will include qualitative interviews. These will explore the lived experiences of two groups: (1) BTC participants who report using the training to support a peer, and (2) peers who report being positively impacted by someone who completed BTC. This qualitative component will use a semi-structured interview format and thematic analysis to explore how BTC skills were used in real-world interactions and the perceived outcomes of those interactions.

The total duration of all study activities will be approximately 12 months, including recruitment, implementation, follow-up data collection, and analysis. Each individual participant's involvement will span approximately 12 weeks. Participants in the intervention group will be expected to complete the BTC program within the first 2 weeks of enrollment. All participants will complete surveys at baseline (T0), ~2 weeks after enrollment (T1), and again at a 12-week follow-up (T2). During the T1 survey, intervention group participants will complete a feasibility, usability, and acceptability survey whereas control group will complete a general survey about health and digital technologies. A subset of participants in the intervention group and their peers will be invited for qualitative interviews, which will occur after the final survey at T2.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • 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 Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be currently enrolled as an undergraduate student at one of the two participating universities
  • Live in shared housing (e.g., dormitory)
  • Be able to read and understand English
  • Be willing to provide informed consent

Exclusion Criteria:

  • Has previously completed the program
  • Is unable or unwilling to complete the study activities (e.g., online modules, surveys, or interviews)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist control
Participants in the waitlist control group will receive access to BTC after completing the final follow-up.
Experimental: Online peer-support training
Participants in the intervention group will complete the BTC program shortly after enrollment.
Behavioral: Be There Certificate
The Be There Certificate (BTC) program, developed by Jack.org and the Born This Way Foundation, aims to provide young people with structured, evidence-informed guidance on how to recognize signs of struggle, offer support, and connect peers to appropriate help.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants in the intervention group who complete the intervention- Feasibility
Time Frame: Immediate post-intervention, Day 1
Percentage of participants completing the program to assess the feasibility of the intervention.
Immediate post-intervention, Day 1
Acceptability of Intervention Measure (AIM)
Time Frame: Immediate post-intervention, Day 1
4 items from Acceptability of Intervention Measure (AIM) ranging from "completely disagree" to "completely agree", will be completed to access the acceptability and appropriateness of the intervention. It provides a score value from 1 to 5, where higher scores indicate higher acceptability.
Immediate post-intervention, Day 1
System Usability Scale (SUS)
Time Frame: Immediate post-intervention, Day 1
The System Usability Scale (SUS), 10 items ranging from "completely disagree" to "completely agree" will be completed to access the usability of the intervention. It provides a score from 0 to 100, where higher scores indicate better usability.
Immediate post-intervention, Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Kimberly Hieftje, PhD, Yale University

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)

September 16, 2025

Primary Completion (Actual)

November 26, 2025

Study Completion (Actual)

November 26, 2025

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000039773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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