Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:45 AM
Study NCT ID:
NCT07460635
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Evaluation of Digital Peer-Support Intervention for College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants in the intervention group who complete the intervention- Feasibility', 'timeFrame': 'Immediate post-intervention, Day 1', 'description': 'Percentage of participants completing the program to assess the feasibility of the intervention.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Immediate post-intervention, Day 1', 'description': '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.'}, {'measure': 'System Usability Scale (SUS)', 'timeFrame': 'Immediate post-intervention, Day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peer support interventions', 'Peer-to-peer support'], 'conditions': ['Peer Support Interventions', 'Mental Health']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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.\n\nTo 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be currently enrolled as an undergraduate student at one of the two participating universities\n* Live in shared housing (e.g., dormitory)\n* Be able to read and understand English\n* Be willing to provide informed consent\n\nExclusion Criteria:\n\n* Has previously completed the program\n* Is unable or unwilling to complete the study activities (e.g., online modules, surveys, or interviews)'}, 'identificationModule': {'nctId': 'NCT07460635', 'briefTitle': 'Pilot Evaluation of Digital Peer-Support Intervention for College Students', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pilot Evaluation of College Peer-Support Intervention to Increase Mental Health Literacy and Skills', 'orgStudyIdInfo': {'id': '2000039773'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in the intervention group will complete the BTC program shortly after enrollment.', 'interventionNames': ['Behavioral: Be There Certificate']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants in the waitlist control group will receive access to BTC after completing the final follow-up.'}], 'interventions': [{'name': 'Be There Certificate', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Kimberly Hieftje, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}