Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

July 18, 2023 updated by: University of North Carolina, Chapel Hill

Brief Intervention to Prevent Alcohol Socialization / Better Informed Parents Keeping Adolescents Safe From Alcohol (BIPAS Alcohol)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nisha Gottfredson O'Shea, PhD
  • Phone Number: 919-248-1826
  • Email: nishaoshea@rti.org

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina At Chapel Hill
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Families receive text messages for three months.
Behavioral: BIPAS Alcohol
Weekly text messages for three months.
No Intervention: Waitlist-control arm
Families are randomized into a control group for three months and begin receiving text messages for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parental Pro-sipping Beliefs Score
Time Frame: Baseline, three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Melissa Gilkey, PhD, UNC Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0101
  • 1R34AA028856-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will be following NIAAA's requirements regarding sharing outcome data of sharing de-identified, individual-level data to the NIAAA Data Archive. The data are made public after an embargo period following the end date of the research award.

IPD Sharing Time Frame

after an embargo period following the end date of the research award

IPD Sharing Access Criteria

In accordance with NIAAA data archive requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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