Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

NCT05520333 — Not applicable, Completed, 132 participants, University of North Carolina, Chapel Hill

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

Registry	NCT05520333
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	132 (Actual)
Sponsor	University of North Carolina, Chapel Hill (Other); collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol, Adolescent Behavior
Interventions	BIPAS Alcohol (Behavioral)
Dates	start 2023-05-01, primary completion 2024-07-30, completion 2024-07-30, first posted 2022-08-29, last updated 2025-06-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention arm	Experimental	Behavioral: BIPAS Alcohol	Families receive text messages for three months.
Waitlist-control arm	No intervention		Families are randomized into a control group for three months and begin receiving text messages for three months.

BIPAS Alcohol (Behavioral): Weekly text messages for three months.

+Outcome measures

Primary outcomes

Change in Mean Value of Parental Pro-sipping Beliefs Score [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts 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.

+Posted results

Participant flow

Milestone	Intervention Arm	Waitlist-control Arm
Started	69	63
Completed	66	57
Not completed	3	6

Outcome results

Change in Mean Value of Parental Pro-sipping Beliefs Score (Primary), Mean, score on a scale: Intervention Arm 0.13 +/- 0.14; Waitlist-control Arm 0.08 +/- 0.16

Adverse events

Time frame: Adverse events were not collected.

Arm	Deaths	Serious adverse events	Other adverse events
Intervention Arm	0	0	0
Waitlist-control Arm	0	0	0

+Locations (1)

Facility	City	Country	Status
University of North Carolina at Chapel Hill	Chapel Hill, North Carolina	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2024-12-05)
Informed Consent Form (PDF, 2023-03-10)

+Investigators

Melissa Gilkey, PhD, Principal investigator, UNC Chapel Hill

+Funding

NIH grants: R34AA028856