Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

NCT ID: NCT05520333

Last Updated: 2025-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-30

Brief Summary

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Early alcohol socialization occurs within the family. This multi-level, high-reach, low-intensity intervention to prevent early alcohol use capitalizes on the influence of providers, immunization timing, and pediatric guidelines that advise healthcare providers to give anticipatory guidance about early alcohol use. In conjunction, the intervention capitalizes on the power of technology to reinforce and expand upon pediatrician messages.

The study seeks to understand the feasibility and effectiveness of a pilot intervention designed to prevent alcohol socialization through education of parents of rising 6th grade students.

Detailed Description

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Conditions

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Alcohol Drinking, Adolescent Drinking Behavior Drinking, Alcohol Adolescent Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm

Families receive text messages for three months.

Group Type EXPERIMENTAL

BIPAS Alcohol

Intervention Type BEHAVIORAL

Weekly text messages for three months.

Waitlist-control arm

Families are randomized into a control group for three months and begin receiving text messages for three months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BIPAS Alcohol

Weekly text messages for three months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years or older;
* Parent or guardian of an enrolled child at a study clinic;
* Cohabitate part time (2 days/week) or more with enrolled child;
* Be able to complete study activities in English;
* Be able to give informed consent;
* Own a phone with text message capabilities and access to internet.

Exclusion Criteria

* Families in which the 10-to-12-year old child is actively receiving treatment for alcohol use disorder.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Gilkey, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R34AA028856-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-0101

Identifier Type: -

Identifier Source: org_study_id

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