Peer Support InterventionsNCT07460635
Pilot Evaluation of Digital Peer-Support Intervention for College Students
A study testing Be There Certificate in people with Peer Support Interventions and Mental Health, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Peer Support Interventions, Mental Health
- What is being tested?
- Be There Certificate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 26 Nov 2025
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Has previously completed the program
- Is unable or unwilling to complete the study activities (e.g., online modules, surveys, or interviews)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: 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
Read the 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.
- Conditions
- Peer Support Interventions, Mental Health
- Being tested
- Be There Certificate
- Keywords
- Peer support interventions, Peer-to-peer support
- 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.
Be There CertificateBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online peer-support training | Experimental | Participants in the intervention group will complete the BTC program shortly after enrollment. Receives: Behavioral: Be There Certificate |
| Waitlist control | No intervention | Participants in the waitlist control group will receive access to BTC after completing the final follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in the intervention group who complete the intervention- Feasibility
Percentage of participants completing the program to assess the feasibility of the intervention.
Measured: Immediate post-intervention, Day 1
Acceptability of Intervention Measure (AIM)
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.
Measured: Immediate post-intervention, Day 1
System Usability Scale (SUS)
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.
Measured: Immediate post-intervention, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Sep 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer Support InterventionsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Grounded in Social Cognitive Theory, the Be There Certificate aims to promote the development of practical peer support skills through scenario-based exercises, interactive practice exercises, and reflection activities.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Hieftje, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460635
- Sponsor's protocol ID
- 2000039773
- Status last verified
- May 2026
- First submitted
- 3 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of College Peer-Support Intervention to Increase Mental Health Literacy and Skills
- ClinicalTrials.gov ID
- NCT07460635
- Acronym / sponsor ID
- 2000039773
- Conditions
- Peer Support Interventions, Mental Health
- Keywords
- Peer support interventions, Peer-to-peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 10 Mar 2026 (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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Grounded in Social Cognitive Theory, the Be There Certificate aims to promote the development of practical peer support skills through scenario-based exercises, interactive practice exercises, and reflection activities.
| Arm | Type | Receives |
|---|---|---|
| Online peer-support training | Experimental | Behavioral: Be There CertificateParticipants in the intervention group will complete the BTC program shortly after enrollment. |
| Waitlist control | No intervention | –Participants in the waitlist control group will receive access to BTC after completing the final follow-up. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Has previously completed the program
- Is unable or unwilling to complete the study activities (e.g., online modules, surveys, or interviews)
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 |
|---|---|---|
| Be There CertificateThe 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. | Behavioural | Online peer-support training |
Primary outcome
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.
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.
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.
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 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Kimberly Hieftje, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be There Certificate in people with Peer Support Interventions and Mental Health, run by Yale University at 1 site 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 4 inclusion and 2 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of participants in the intervention group who complete the intervention- Feasibility (time frame: Immediate post-intervention, Day 1). The study lists 3 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 7 May 2026.