NCT07683702

Brief 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. This promising digital intervention that teaches parents about their influence and provides skills and tools they need to discourage underage alcohol use.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for phase_3

Timeline
37mo left

Started Sep 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 19, 2026

Last Update Submit

June 27, 2026

Conditions

Keywords

alcohol misuseadolescent healthsubstance use preventionalcohol preventionparenting

Outcome Measures

Primary Outcomes (1)

  • Adolescent alcohol quantity frequency (AQF)

    Frequency and amount of drinking over the past 30 days

    From enrollment to 24 months

Secondary Outcomes (2)

  • Parent alcohol attitudes and beliefs

    From enrollment to 24 months

  • Parental allowance of sipping

    From enrollment to 24 months

Study Arms (2)

BIPAS Alcohol intervention group

EXPERIMENTAL

BIPAS Alcohol intervention

Behavioral: BIPAS Alcohol

Control group

NO INTERVENTION

Does not receive intervention

Interventions

BIPAS AlcoholBEHAVIORAL

Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use

Also known as: BIPAS
BIPAS Alcohol intervention group

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Another child from the same family/household is already participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Nisha Gottfredson O'Shea, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Pearsall, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Epidemiologist

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Primary outcome variables for individual participants will be shared on the NIMH Data Archive

Shared Documents
STUDY PROTOCOL, ICF