User Testing and Feasibility Study of an Intervention Addressing Young Adults' Experiences With Alcohol and Romantic Relationships
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Anxiety symptoms
研究概览
简要总结
Whole Selves is a novel print and online intervention using motivational interviewing principles and personalized feedback to address young adults' alcohol use and romantic relationship functioning. In this study, the investigators will conduct user testing interviews (online and in-person) with 10 young adults to obtain feedback on the Whole Selves intervention prototype, thereby improving its usability, relevance, and user engagement. The investigators will then conduct a single-arm feasibility study of Whole Selves with 107 young adults in order to (1) assess the intervention's acceptability and potential mechanisms and (2) assess feasibility and parameters for a future randomized trial.
详细描述
This study is a single-arm feasibility study of Whole Selves, an interactive online resource, or intervention, to help transgender/nonbinary young adults reflect on their goals and priorities for their alcohol use and their romantic relationships. Unlike existing alcohol interventions and relationship education programs, Whole Selves is being created in partnership with transgender/nonbinary young adults, and it considers ways that being transgender/nonbinary might affect someone's alcohol use or their romantic relationship experiences. Whole Selves will be based on principles of motivational interviewing, a way of helping people think about changes they might make in certain areas of life (such as their alcohol use). Whole Selves will include stories and videos of transgender/nonbinary people sharing their own experiences with alcohol use and romantic relationships. It will also include interactive activities, such as giving users feedback on how their alcohol use compares to averages for transgender/nonbinary young adults.
In this study, the investigators will ask 107 romantically partnered transgender/nonbinary young adults to use the Whole Selves intervention, and they will collect survey data from participants before and after the intervention. They will use this data to improve the intervention, see whether it seems to work in the ways the investigators expected, and make plans for a future randomized trial that could show whether the intervention is effective in reducing alcohol use, depression, and anxiety.
Participants in this feasibility study will take part remotely, using their own computer or mobile device. They will first have a phone call with someone from the research team to learn more about the study. They will then complete an initial survey about their background, romantic relationship experiences, mental health, and alcohol use. Next, they will use the Whole Selves intervention, which takes about 40 minutes, on their own computer or mobile device. Afterwards, they will fill out a short survey with feedback about Whole Selves. Finally, they will fill out two more surveys about their romantic relationship experiences, mental health, and alcohol use after 30 days and 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and write in English
- •Residency in the United States
- •Currently in a romantic relationship that began at least six weeks prior to enrollment
排除标准
- •Referral source has generated other suspicious responses
- •Submitted within 48 hours of other responses with similar or identical content
- •Blank or nonsense response to at least one write-in question
- •Email address has pattern common in inauthentic responses (e.g., full name followed by a 3- or 4-digit number, last name followed by first name, or full name that appears unrelated to participant's stated name)
- •Reported nonstandard demographic information
- •Provided an email address with a domain other than gmail.com
- •Via Zoom, displaying a photo ID associated with the reported location (school/employer IDs acceptable)
- •Via Zoom, displaying a physical item associated with the reported location, such as a transit pass, library card, or university paraphernalia
研究组 & 干预措施
Whole Selves
Participants assigned to this arm will receive the Whole Selves intervention and complete assessment surveys at baseline, 30 days, and 90 days.
干预措施: Whole Selves (Behavioral)
结局指标
主要结局
Anxiety symptoms
时间窗: Baseline, 30 days, 90 days
Self-report of generalized anxiety symptoms in the prior 30 days, as measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item instrument with each item scored between 0 and 3 where 0=not at all, and 3= nearly every day. Scores can range from 0 to 21 and are interpreted as-- scores 0-4: Minimal Anxiety, scores 5-9: Mild Anxiety, scores 10-14: Moderate Anxiety, and scores greater than 15: Severe Anxiety.
Depression symptoms
时间窗: Baseline, 30 days, 90 days
Self-report of depression symptoms in the prior 30 days, as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire with each item scored from 0 to 3. Scores can range from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Alcoholic drinks per week
时间窗: Baseline, 30 days, 90 days
Average (mean) number of alcoholic drinks per week based on 14-day timeline followback, i.e., retrospective self-report of drinks per day.
次要结局
- Negative alcohol consequences(Baseline, 30 days, 90 days)
- Transgender/nonbinary (TNB) identity support(Baseline, 30 days, 90 days)
- Relationship satisfaction(Baseline, 30 days, 90 days)
- Intimate Personal Violence (IPV) victimization(Baseline, 30 days, 90 days)
- Heavy drinking days(Baseline, 30 days, 90 days)
- Component-specific user engagement(30 days, 90 days)
- Participant accrual rate during the feasibility study(30 days, 90 days)