An interventional study of BIPAS Alcohol in Alcohol Drinking, Adolescent, Drinking Behavior and Drinking, Alcohol, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 132 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Families receive text messages for three months.
Behavioral: BIPAS Alcohol
Families are randomized into a control group for three months and begin receiving text messages for three months.
Weekly text messages for three months.
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.
Time frame: Baseline, three months
Recruitment occurred from May to November 2023. Participants were recruited through school newsletters, social media posts, information dissemination through educational institutions and local pediatric clinics, and word of mouth.
| Milestone | Intervention Arm | Waitlist-control Arm |
|---|---|---|
| Started | 69 | 63 |
| Completed | 66 | 57 |
| Not completed | 3 | 6 |
| Withdrew: Lost to follow-up | 3 | 6 |
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.
| score on a scale | Intervention Arm | Waitlist-control Arm |
|---|---|---|
| Change in Mean Value of Parental Pro-sipping Beliefs Score | 0.13 ± 0.14 | 0.08 ± 0.16 |
Collected over Adverse events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | — | — | — |
| Waitlist-control Arm | — | — | — |
Note that demographics were only collected for parent participants (not children).
| Age, Categorical(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 69 | 63 | 132 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 66 | 57 | 123 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 61 | 52 | 113 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Parent drinks alcohol(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| Yes | 56 | 47 | 103 |
| No | 13 | 16 | 29 |
| Parent/guardian relationship with child(Participants) | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| Mother | 61 | 54 | 115 |
| Father | 8 | 8 | 16 |
| Guardian | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Time frame: after an embargo period following the end date of the research award
Access criteria: In accordance with NIAAA data archive requirements.
Data sharing details ↗ · www.niaaa.nih.gov
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill →