College Student Stress: Transitions Over Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Percentage of Eligible Participants Who Agreed to Participate in the Trial
研究概览
简要总结
This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.
This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). There were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-year college students that are full-time or part-time students enrolled at the University of Michigan, Ann Arbor or Flint campuses
- •Mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible
排除标准
- •Under the age of 17
- •Currently be receiving mental health therapy/counseling from a healthcare professional
- •Experiencing minimal depressive symptoms (defined in protocol)
- •Experiencing moderately severe to severe depressive symptoms (defined in protocol)
结局指标
主要结局
Percentage of Eligible Participants Who Agreed to Participate in the Trial
时间窗: Up to 10 days after screening survey
Of the individuals meeting eligibility criteria (i.e., mild-to-moderate depressive symptoms, no current mental health service utilization) from the initial screen, what percentage agreed to be enrolled and randomized into the clinical trial.
Percentage of Participants Who Completed Follow-ups
时间窗: Baseline up to six-week follow-up
Weekly ten-minute surveys assessing mental health symptoms, stress, and adaptive functioning were sent to participants. Results reflect the number of participants who completed their survey each week.
Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group
时间窗: Baseline up to six-week follow-up
Results reflect the participants who remained active during the full trial in the intervention group.
Number of Withdrawals
时间窗: Baseline up to six-week follow-up
Results reflect participants who requested to withdraw from the trial.
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
时间窗: Baseline up to six-week follow-up
As part of the intervention arm, participants were randomized each week to receive or not receive personalized feedback reports. Reports had graphical explanations of the participant's responses to the survey questions. The data values reported reflect the number of participants who viewed feedback reports, while the Number Analyzed for each Row reflects the number of participants who were sent a personalized feedback report that week.
Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once
时间窗: Baseline up to six-week follow-up
As part of the intervention, some participants in the intervention arm were randomly sent feedback reports. Reports had graphical explanations of the participant's response to the survey questions. All participants in the intervention arm were sent at least one feedback report during the course of the trial. Results reflect the number of participants who viewed at least one report.
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
时间窗: Six-week follow-up
Participants in the "Assessment Only" arm who completed the 6-week follow-up survey responded to an 8-question survey regarding their satisfaction with the study. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction with the study. Results reflect the average participant scores for each question.
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
时间窗: Six-week follow-up
Participants in the "Intervention" arm who completed the 6-week follow-up survey responded to an 18-question survey regarding their satisfaction with the intervention. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction. Results reflect the average participant scores for each question.
次要结局
未报告次要终点
研究者
Adam Horwitz
Assistant Professor of Psychiatry
University of Michigan