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临床试验/NCT07460635
NCT07460635已完成不适用

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

Yale University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Percentage of participants in the intervention group who complete the intervention- Feasibility

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Waitlist control

No Intervention

Participants in the waitlist control group will receive access to BTC after completing the final follow-up.

结局指标

主要结局

Percentage of participants in the intervention group who complete the intervention- Feasibility

时间窗: Immediate post-intervention, Day 1

Percentage of participants completing the program to assess the feasibility of the intervention.

Acceptability of Intervention Measure (AIM)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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