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Completed

NCT Number: NCT07460635

Pilot Evaluation of Digital Peer-Support Intervention for College Students

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

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Be There Certificate

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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