Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
2026年6月18日 更新者：Dana Litt、The University of Texas at Arlington
A Hybrid Type 1 Effectiveness Implementation Trial of a Parent-Based Intervention to Address Social Media Influences on Adolescent Alcohol Outcomes
The central goal of this application is to conduct a Hybrid Type 1 effectiveness-implementation randomized controlled trial to test the comparative effectiveness of an alcohol and social media parent-based intervention (PBI), compared to both a combined approach whereby parents receive the alcohol and social media PBI and adolescents receive an alcohol and social media personalized feedback intervention (PFI) and to an efficacious alcohol PBI handbook.
Additionally, we will determine key implementation determinants that are crucial to optimizing effectiveness when delivered in community settings.
The proposed study will address each of these goals in turn by enrolling parent and adolescent (age 12-17) dyads and collaborating with key community members.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
900
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dana Litt, PhD
- 电话号码：3032044109
- 邮箱：dana.litt@uta.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
描述
Parents/legal guardian inclusion criteria:
- Have a child between the ages of 12-17 who lives with them
- Believe that their child is active on at least one social media platform
- Live in Texas
- Provide a valid email and phone number
- Own a cell phone with text messaging capabilities and be okay with receiving messages
- Provide valid contact information for their adolescent
- Willing to participate in respective phase.
Adolescent inclusion criteria:
- Have an eligible parent with whom they live
- Age 12-17
- Live in Texas
- Active at least weekly on at least one social media platform
- Provide a valid phone number and email address
- Own a cell phone with text messaging capabilities and be okay with receiving text messages,
- Willing to participate in respective phase
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work.
The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors.
Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
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Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work (PI: Litt, R21AA024163; Litt et al., 2023; Lewis et al., 2019; Larimer et al., 2021, 2023).
The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors.
Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
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有源比较器：Alcohol and Social Media PBI
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs.
The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules).
The website will allow parents to navigate through the modules at their own pace/sequence.
Each module will have interactive elements including animations, infographics, and videos to highlight key content.
Parents will be sent one text message per week encouraging them to use the website.
|
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs.
The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules).
The website will allow parents to navigate through the modules at their own pace/sequence.
Each module will have interactive elements including animations, infographics, and videos to highlight key content.
Parents will be sent one text message per week encouraging them to use the website.
|
|
有源比较器：Alcohol PBI
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish.
The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
|
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish.
The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Drinking Refusal Self-Efficacy
大体时间：Baseline, 1, 6, 12 month assessments
|
The Drinking Refusal Self-Efficacy Questionnaire will assess beliefs in one's ability to resist alcohol (Young et al., 2007; α = .96).
Responses range from 1 (I am very sure I would drink) to 6 (I am sure I would not drink) with higher scores indicating greater drinking refusal self-efficacy.
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Baseline, 1, 6, 12 month assessments
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Alcohol-related social media communication
大体时间：Baseline, 1, 6, 12 month assessments
|
Alcohol-related social media communication between parents and adolescents will be assessed using the "Alcohol-related Social Media Communication Scale, which is adapted from Turrisi et al., 2000; α = .96).
Participants will indicate whether they spoke about a range of topics (yes/no) in the past month with higher scores indicating greater alcohol-related social media communication.
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Baseline, 1, 6, 12 month assessments
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Alcohol Willingness
大体时间：Baseline, 1, 6, 12 month assessments
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The willingness measure will assess adolescent willingness to drink in certain scenarios (α = .85;
Gerrard et al., 2008) using a response rage of 0 (not at all willing) to 4 (extremely willing).
Higher scores indicate greater willingness to use alcohol.
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Baseline, 1, 6, 12 month assessments
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alcohol Initiation
大体时间：Baseline, 1, 6, 12 month assessments
|
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to participants' reported date of first use using timeline follow-back methods (Sobell & Sobell, 1992) and reporting the approximate date they first used alcohol, an approach used in our current work (R01AA025611).
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Baseline, 1, 6, 12 month assessments
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年7月1日
初级完成 (估计的)
2030年8月1日
研究完成 (估计的)
2030年8月1日
研究注册日期
首次提交
2026年6月15日
首先提交符合 QC 标准的
2026年6月18日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年6月24日
上次提交的符合 QC 标准的更新
2026年6月18日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.