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Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

Primary Purpose

Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BIPAS Alcohol
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking, Adolescent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Waitlist-control arm

Arm Description

Families receive text messages for three months.

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

Outcomes

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2022
Last Updated
July 18, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05520333
Brief Title
Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)
Official Title
Brief Intervention to Prevent Alcohol Socialization / Better Informed Parents Keeping Adolescents Safe From Alcohol (BIPAS Alcohol)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Families receive text messages for three months.
Arm Title
Waitlist-control arm
Arm Type
No Intervention
Arm Description
Families are randomized into a control group for three months and begin receiving text messages for three months.
Intervention Type
Behavioral
Intervention Name(s)
BIPAS Alcohol
Intervention Description
Weekly text messages for three months.
Primary Outcome Measure Information:
Title
Change in Parental Pro-sipping Beliefs Score
Description
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.
Time Frame
Baseline, three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisha Gottfredson O'Shea, PhD
Phone
919-248-1826
Email
nishaoshea@rti.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Pearsall, MPH
Email
mpear@live.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Gilkey, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nisha Gottfredson, PhD
Phone
919-445-9385
Email
gottfredson@unc.edu
First Name & Middle Initial & Last Name & Degree
Marina Pearsall, MPH
Email
mpear@live.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.niaaa.nih.gov/research/niaaa-data-archive

Learn more about this trial

Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

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