Effectiveness Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BIPAS Alcohol.
- Who it may be relevant to
- Registry conditions: Alcohol Misuse, Alcohol Prevention. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Type I Hybrid Implementation Effectiveness Cluster Randomized Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
Overview
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.
Detailed description
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.
Interventions
- Behavioral BIPAS Alcohol
Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use
Primary outcome measures
- Adolescent alcohol quantity frequency (AQF) [Time frame: From enrollment to 24 months]
Secondary outcome measures (2)
- Parent alcohol attitudes and beliefs [Time frame: From enrollment to 24 months]
- Parental allowance of sipping [Time frame: From enrollment to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07683702 · R01AA031980 · R01AA031980