Alcohol MisusePhase 3BIPAS AlcoholNCT07683702
Effectiveness Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
A Phase 3 study testing BIPAS Alcohol in people with Alcohol Misuse and Alcohol Prevention, run by RTI International.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse, Alcohol Prevention
- What is being tested?
- BIPAS Alcohol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be age 18 or older and
- Be the parent or guardian of a child in or entering 5th or 6th grade
- Child must be in 5th or 6th grade and 9-13 years old
- 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
Show all 9Show fewer
- 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
Who cannot join
- Another child from the same family/household is already participating
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Misuse, Alcohol Prevention
- Being tested
- BIPAS Alcohol
- Keywords
- alcohol misuse, adolescent health, substance use prevention, alcohol prevention, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAS AlcoholBehavioural
Also called BIPAS
Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use
| Study group | Role | What they receive |
|---|---|---|
| BIPAS Alcohol intervention group | Experimental | BIPAS Alcohol intervention Receives: Behavioral: BIPAS Alcohol |
| Control group | No intervention | Does not receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent alcohol quantity frequency (AQF)
Frequency and amount of drinking over the past 30 days
Measured: From enrollment to 24 months
Secondary outcomes (2)
Parent alcohol attitudes and beliefs
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.
Measured: From enrollment to 24 months
Parental allowance of sipping
Questionnaire responses to item asking if parent allows child to sip alcohol. Response options are: never; rarely; sometimes; often; very often.
Measured: From enrollment to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Nisha Gottfredson O'Shea, RTI International
- Investigators
- Nisha Gottfredson O'Shea, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683702
- Sponsor's protocol ID
- R01AA031980
- Other IDs
- R01AA031980
- Acronym
- BIPAS Alcohol
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary outcome variables for individual participants will be shared on the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type I Hybrid Implementation Effectiveness Cluster Randomized Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
- ClinicalTrials.gov ID
- NCT07683702
- Acronym / sponsor ID
- BIPAS Alcohol / R01AA031980
- Conditions
- Alcohol Misuse, Alcohol Prevention
- Keywords
- alcohol misuse, adolescent health, substance use prevention, alcohol prevention, parenting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIPAS Alcohol intervention group | Experimental | Behavioral: BIPAS AlcoholBIPAS Alcohol intervention |
| Control group | No intervention | –Does not receive intervention |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Be age 18 or older and
- Be the parent or guardian of a child in or entering 5th or 6th grade
- Child must be in 5th or 6th grade and 9-13 years old
- Cohabitate part-time (averaging at least 2 days/week) or more with index child
- Consent to being randomized to study arm
Key exclusion criteria (1 listed)
- Another child from the same family/household is already participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIPAS AlcoholAlso: BIPASDigital intervention for parents of rising middle schoolers to prevent early onset alcohol use | Behavioural | BIPAS Alcohol intervention group |
Primary outcome
Adolescent alcohol quantity frequency (AQF)
Time frame: From enrollment to 24 months
Frequency and amount of drinking over the past 30 days
2 secondary outcomes
Parent alcohol attitudes and beliefs
Time frame: From enrollment to 24 months
Parental allowance of sipping
Time frame: From enrollment to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Primary outcome variables for individual participants will be shared on the NIMH Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nisha Gottfredson O'Shea, PhD principal investigator
RTI International
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BIPAS Alcohol in people with Alcohol Misuse and Alcohol Prevention, run by RTI International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Pearsall, MPH (9849991617, mpearsall@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent alcohol quantity frequency (AQF) (time frame: From enrollment to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.