Effectiveness Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use (BIPAS Alcohol)
2026年6月27日 更新者:Nisha Gottfredson O'Shea、RTI International
Type I Hybrid Implementation Effectiveness Cluster Randomized Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
Many parents are permissive about children's alcohol use (e.g., they allow sips of alcohol); this leniency increases the risk that children will experience serious alcohol-related consequences as they become teenagers.
This promising digital intervention that teaches parents about their influence and provides skills and tools they need to discourage underage alcohol use.
研究概览
详细说明
Drinking before age 14, or "early-onset alcohol use" (EOAU), is a serious and highly prevalent risk behavior that often begins at home, with sips of alcohol provided by parents.
By age 11, nearly one-quarter of U.S. children have already sipped alcohol.
This research has identified specific parenting beliefs and behaviors that are not being adequately addressed in family-based interventions.
This research shows that many parents who provide alcohol have the mistaken belief that doing so teaches children how to drink in moderation; other parents report simply not having given thought to the risks.
Even in the context of other protective factors, adolescents whose parents had permissive beliefs about alcohol use exhibited quicker escalations in alcohol involvement across adolescence than did those whose parents had less permissive beliefs.
The investigators developed and piloted an intervention program called Better Informed Parents Keeping Adolescents Safe from Alcohol (BIPAS Alcohol), which is a universal, theory-informed, digital intervention for parents of incoming middle schoolers that is delivered via mobile devices.
Findings from the pilot study demonstrated that BIPAS is highly acceptable to parents and can be delivered at low cost.
Furthermore, preliminary results show that BIPAS Alcohol is effective across a range of cognitive and behavioral outcomes, including parental provision of sips of alcohol to their children.
Building on this research, the current application has the following aims.
Aim 1: Expand the reach of BIPAS Alcohol by translating it into Spanish while maintaining fidelity to key intervention content; Aim 2: Use a rigorous national cluster-randomized trial with 2,000 parent-child dyads (N = 4,000 total) to assess the effects of BIPAS Alcohol on EOAU, secondary outcomes (e.g., children's alcohol use susceptibility), and hypothesized mediators that are the target of the intervention (e.g., parental permissive beliefs about adolescent alcohol use) relative to an attention control condition; and Aim 3: Evaluate implementation outcomes, including program reach, participant engagement and experience, and delivery cost.
Aim 3 will include qualitative interviews to identify implementation supports that address factors that inhibit engagement.
Across all aims, the investigators will examine variability in mechanisms and outcomes across multiple dimensions, including parent language, educational attainment, and alcohol use status.
By rigorously testing the effectiveness of a universal digital intervention with the potential for widespread reach, this study will provide novel evidence for reducing EOAU and its associated consequences.
Furthermore, findings regarding implementation supports for reaching families will provide insights into how best to support engagement more broadly across other digital parenting interventions.
研究类型
介入性
注册 (估计的)
4000
阶段
- 第三阶段
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:Marina Pearsall, MPH
- 电话号码:9849991617
- 邮箱:mpearsall@rti.org
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
Inclusion Criteria:
- Be age 18 or older and
- Be the parent or guardian of a child in or entering 5th or 6th grade
- Cohabitate part-time (averaging at least 2 days/week) or more with index child
- Consent to being randomized to study arm
- Be able to complete study activities in Spanish or English
- Own or have regular access to a smartphone that can download apps
- Be willing to turn on app notifications for the study app
- Consent to having their child complete surveys privately
Exclusion Criteria:
- Another child from the same family/household is already participating
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 |
|---|---|
|
实验性的:BIPAS Alcohol intervention group
BIPAS Alcohol intervention
|
Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use
其他名称:
|
|
无干预:Control group
Does not receive intervention
|
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 |
|---|---|---|
|
Adolescent alcohol quantity frequency (AQF)
大体时间:From enrollment to 24 months
|
Frequency and amount of drinking over the past 30 days
|
From enrollment to 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Parent alcohol attitudes and beliefs
大体时间:From enrollment to 24 months
|
Questionnaire responses to items focusing on parent's beliefs about anticipated effects of alcohol consumption.
Response options are: strongly agree; disagree; agree; and strongly agree.
|
From enrollment to 24 months
|
|
Parental allowance of sipping
大体时间:From enrollment to 24 months
|
Questionnaire responses to item asking if parent allows child to sip alcohol.
Response options are: never; rarely; sometimes; often; very often.
|
From enrollment to 24 months
|
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。
调查人员
- 首席研究员:Nisha Gottfredson O'Shea, PhD、RTI International
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)
2026年9月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2029年9月1日
研究注册日期
首次提交
2026年6月19日
首先提交符合 QC 标准的
2026年6月27日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月27日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- R01AA031980 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Primary outcome variables for individual participants will be shared on the NIMH Data Archive
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.