Alcohol Drinking, AdolescentNCT05520333

Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

A study testing BIPAS Alcohol in people with Alcohol Drinking, Adolescent and Drinking Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol
What is being tested?: BIPAS Alcohol
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteUnited States
Study dates: 1 May 2023to 30 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

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
Being tested: BIPAS Alcohol
Medical subject headings: Underage Drinking, Drinking Behavior, Alcohol Drinking, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIPAS AlcoholBehavioural
Weekly text messages for three months.

Study groups in NCT05520333
Study group	Role	What they receive
Intervention arm	Experimental	Families receive text messages for three months. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202330 Jul 2024

First posted29 Aug 2022
Study start1 May 2023
Primary completion30 Jul 2024
Study completion30 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol Drinking, AdolescentStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05520333
Sponsor's protocol ID: 22-0101
Other IDs: 1R34AA028856-01A1
Status last verified: Sep 2024
First submitted: 25 Aug 2022
Last updated: 8 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brief Intervention to Prevent Alcohol Socialization / Better Informed Parents Keeping Adolescents Safe From Alcohol (BIPAS Alcohol)
ClinicalTrials.gov ID: NCT05520333
Acronym / sponsor ID: 22-0101
Conditions: Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol, Adolescent Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 1 May 2023 (actual)
Primary completion: 30 Jul 2024 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 29 Aug 2022 (actual)
Results: Posted 8 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention arm	Experimental	Behavioral: BIPAS AlcoholFamilies 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIPAS AlcoholWeekly text messages for three months.	Behavioural	Intervention arm

Primary outcome

Change in Mean Value of 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.

Results and safety

Results posted to the registry on 8 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	69	66
Waitlist-control Arm	63	57

Primary outcome: Change in Mean Value of Parental Pro-sipping Beliefs Score

Time frame: Baseline, three months. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Arm n = 66	Waitlist-control Arm n = 57
Value	0.13 (0.14)	0.08 (0.16)

Adverse events

Time frame: Adverse events were not collected.. Other adverse events reported at 0% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Alcohol Drinking, Adolescent

Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
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Not yet recruiting
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Adolescent Alcohol Use
Recruiting
ChangeGradients: Promoting Adolescent Health Behavior Change
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Gilkey, PhD principal investigator

UNC Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BIPAS Alcohol in people with Alcohol Drinking, Adolescent and Drinking Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Value of Parental Pro-sipping Beliefs Score (time frame: Baseline, three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05520333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.