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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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