Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

NCT05520333 | Completed Results

• 2 other identifiers: 22-01011R34AA028856-01A1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Drinking, Adolescent; Drinking Behavior; Drinking, Alcohol; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Change in Mean Value of Parental Pro-sipping Beliefs Score

  Parental Alcohol Socialization Beliefs, Attitudes, and Practices scale (eight items). A four-point scale ranging from "strongly disagree" (lowest value=1) to "strongly agree" (highest value=4) will be used, with higher values on the scale indicating a more pro-sipping belief system. The scores will have a range from 8-32. Higher values are associated with worse outcomes.

  Baseline, three months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Families receive text messages for three months.

Behavioral: BIPAS Alcohol

Waitlist-control arm

NO INTERVENTION

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

Interventions

BIPAS Alcohol BEHAVIORAL

Weekly text messages for three months.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Underage Drinking; Drinking Behavior; Alcohol Drinking; Adolescent Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Nisha Gottfredson O'Shea
• Organization: RTI International

nishaoshea@rti.org

9192481826

Study Officials

• Melissa Gilkey, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: after an embargo period following the end date of the research award
• Access Criteria: In accordance with NIAAA data archive requirements.

Locations

US (1)