Brief Intervention to Prevent Alcohol Socialization / Better Informed Parents Keeping Adolescents Safe From Alcohol (BIPAS Alcohol)
Phase: NA
Conditions: Alcohol Drinking, Adolescent, Drinking Behavior, Drinking, Alcohol, Adolescent Behavior
Sponsor: University of North Carolina, Chapel Hill

 
 
BRIEF INTERVENTION TO PREVENT ALCOHOL SOCIALIZATION 
(BIPAS ALCOHOL) 
 
 
 
 
 
Support provided by: National Institute of Alcohol Abuse and Alcoholism (NIAAA) 
 
Clinical trials number: NCT05520333 
 
Principal Investigator: Melissa Gilkey 
 
Last update: 12/5/24 
 
 
 
 
 

TABLE OF CONTENTS 
 
PROTOCOL SUMMARY ................................................................................................................4 
1 
KEY ROLES .......................................................................................................................7 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................8 
2.1 
2.1 Background information ....................................................................................8 
2.2 
2.2 Rationale ............................................................................................................8 
2.3 
2.3 Potential Risks and Benefits ...............................................................................9 
3 
OBJECTIVES ...................................................................................................................10 
3.1 
3.1 Study objectives ...............................................................................................10 
3.2 
3.2 Study outcome measures .................................................................................10 
4 
STUDY DESIGN ...............................................................................................................11 
5 
STUDY ENROLLMENT AND WITHDRAWAL......................................................................12 
5.1 
Subject inclusion criteria ........................................................................................12 
5.2 
Subject exclusion criteria .......................................................................................12 
5.3 
Strategies for recruitment and retention ...............................................................12 
5.4 
Treatment assignment procedures ........................................................................12 
6 
STUDY INTERVENTION ...................................................................................................14 
6.1 
Study intervention description ...............................................................................14 
6.2 
Dosage, preparation, and administration of study intervention .............................14 
6.3 
Modification of study intervention for a subject ....................................................14 
6.4 
Accountability procedures for the study intervention ............................................14 
6.5 
Assessment of subject compliance with study intervention ...................................14 
6.6 
Concomitant medications/treatments ...................................................................14 
7 
STUDY SCHEDULE ..........................................................................................................15 
7.1 
Screening ...............................................................................................................15 
7.2 
Enrollment/baseline ..............................................................................................15 
7.3 
Follow-up ...............................................................................................................15 
7.4 
Final study visit ......................................................................................................15 
7.5 
Early termination visit ............................................................................................15 
7.6 
Unscheduled visit ...................................................................................................15 
8 
STATISTICAL CONSIDERATIONS ......................................................................................16 
8.1 
Study hypotheses...................................................................................................16 

8.2 
Sample size considerations ....................................................................................16 
8.3 
Planned interim analyses (if applicable) .................................................................16 
8.4 
Final analyses plan .................................................................................................16 
9 
ETHICS/PROTECTION OF HUMAN SUBJECTS ..................................................................17 
9.1 
Ethical standard .....................................................................................................17 
9.2 
Institutional Review Board .....................................................................................17 
9.3 
Informed consent process ......................................................................................17 
9.4 
Exclusion of women, minorities, and children (special populations) .......................17 
9.5 
Subject confidentiality ...........................................................................................17 
9.6 
Study discontinuation ............................................................................................17 
9.7 
Future use of stored specimens .............................................................................17 
 
 

PROTOCOL SUMMARY 
 
Title: 
Brief Intervention to Prevent Alcohol Socialization / Better 
Informed Parents Keeping Adolescents Safe from Alcohol 
(BIPAS Alcohol) 
 
Summary: 
Early alcohol socialization occurs within the family. Our 
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.  
 
Our 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.  
 
Objectives:  
To evaluate the feasibility and preliminary effectiveness of 
an intervention aiming to improve parents’ attitudes about 
child alcohol use. 
 
Primary outcome measure: The change in parents’ score 
from an 8-item scale of pro-sipping beliefs from baseline 
to post-intervention (6 months). 
 
 
Sample: 
Parents of rising 6th grade students. 
 
Phase: 
Phase 0/1 (Intervention development) 
 
Participant duration: 
Parents will participate in a text-based intervention for 
three months and complete surveys for up to 6 months 
after study enrollment. Children will complete one survey 
3 months after study enrollment. 
 
Description of intervention: 
BIPAS Alcohol is an intervention intended to prevent early 
onset alcohol use by educating parents of rising middle 
schoolers. Parents will receive information delivered via 
text message for three months. 
 
Estimated time to complete  

enrollment: 
6 months 
 
 

Schematic of study design: 
 
 
 

1 KEY ROLES 
 
Principal Investigator: 
 
Melissa Gilkey, PhD1 
 
 
Intervention design:  
 
Nisha Gottfredson O’Shea, PhD2 
 
 
 
 
 
 
 
 
Melissa Gilkey, PhD1 
 
 
 
 
 
 
Luz McNaughton Reyes, PhD1 
 
 
Data analysis and reporting:  
Nisha Gottfredson O’Shea, PhD1 
 
 
 
 
 
 
Melissa Gilkey, PhD1 
 
 
 
 
 
 
Luz McNaughton Reyes, PhD1 
 
 
 
 
 
 
Marina Pearsall, MPH2 
 
 
Institutions:  
 
 
1Department of Health Behavior 
 
 
 
 
 
University of North Carolina at Chapel Hill 
 
 
 
 
 
Chapel Hill, NC 
 
 
 
 
 
 
2RTI International 
 
 
 
 
 
Research Triangle Park, NC 
 
 

2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
2.1 2.1 Background information 
 
Early initiation of alcohol use is a uniquely predictive risk for problematic alcohol involvement 
during late adolescence and adulthood. Prospective longitudinal studies show that children 
who have sips of alcohol during early adolescence, typically in the family context, are at higher 
risk for alcohol misuse, binge drinking and development of alcohol-related problems. Youth 
whose family context makes them more susceptible to drinking are also more likely to select 
into pro-alcohol peer groups that reinforce drinking attitudes and behavior. Alcohol misuse is 
the primary contributor to death by injury and is the leading cause of death for those under age 
21. Alcohol use negatively alters brain development and is implicated in risky sexual behavior, 
aggressive and violent behavior, depression and social isolation, poor economic outcomes, 
smoking and other drug use, academic problems, and suicidality. Given the variety and 
magnitude of these negative consequences, early initiation of alcohol use is a major public 
health problem in need of public health interventions that have the potential for wide reach 
and high impact across the life course.  
 
One quarter of 8th grade students and half of 10th grade students have already consumed 
alcohol. A significant minority of youth begin drinking even younger, and alcohol use rates 
double as children transition from elementary to middle school. Whereas only 10% of fourth 
graders have ever tried alcohol, more than 20% of sixth graders report ever drinking. Given this, 
and our finding that school transitions promote risk for onset of substance use, the transition to 
middle school is a critical period for prevention of alcohol initiation. 
 
2.2 2.2 Rationale 
 
Parents are the essential target of early intervention to prevent underage alcohol use initiation. 
A substantial body of evidence shows that permissive parental beliefs about alcohol, and 
concomitant permissive behaviors (e.g., permitted sipping of alcohol at home), are strongly 
associated with children’s self-reported alcohol use. While peers become increasingly 
influential during adolescence, parents are more influential than peers for children and young 
adolescents. Additionally, parental attitudes shape how they monitor adolescent interactions 
with peers, so intervening with parents during early adolescence may also buffer negative peer 
influence. Our prospective analysis showed that, even in the context of other protective factors, 
adolescents whose parents had permissive beliefs about alcohol use exhibited quicker 
escalations in alcohol involvement across adolescence than those whose parents were less 
permissive about their children’s alcohol use. Indeed, permissive parenting practices were more 
strongly predictive of growth in adolescent alcohol misuse than whether the parents 
themselves used alcohol heavily.  
 
Text message-based interventions have been shown to be both acceptable and very effective 
across a variety of behaviors, including with parents. A meta-analysis of 19 RCTs of text 
message-based interventions found that tailored text messages are even more powerful for 

promoting behavior change than un-tailored messages. Mobile phone ownership is near-
universal in the United States (96% in 2019, including 99% of individuals aged 18-49). 
Importantly, mobile phone ownership rates are in the high-90%s for Black, White, and 
Hispanic/Latino individuals.  
 
2.3 2.3 Potential Risks and Benefits 
 
2.3.1 2.3.1 Potential risks 
 
Potential risks associated with participation for parents include loss of time and slight risk of 
embarrassment or discomfort in answering questions about their family practices around 
alcohol. However, because text message viewing is discretionary for parents, we expect loss of 
time to be minimal. All answers to survey questions and data received from text message usage 
will be kept confidential. Thus, the risk of embarrassment is anticipated to be very slight. 
Parents could become distressed about their own drinking behavior. We minimize these risks 
by tailoring the message content to parenting-related behaviors and offering resources on our 
website for parents seeking information about alcohol misuse. 
 
We do not anticipate immediate or long-range risks associated with participation. 
 
2.3.2 2.3.2 Known potential benefits 
 
By participating in this study, parents will receive actionable information about incorporating 
alcohol discussions in their family life. This study will also help inform a future larger 
randomized control trial of the BIPAS Alcohol intervention.   
 
 

3 OBJECTIVES 
 
3.1 3.1 Study objectives 
 
The purpose of this study is to evaluate the feasibility and preliminary effectiveness of BIPAS 
Alcohol, an intervention aiming to reduce pro-sipping beliefs, to encourage creation of clear, 
alcohol-specific rules, and to limit their provision of sips of alcohol to young adolescents. 
 
3.2 3.2 Study outcome measures 
 
Our primary outcome measure is changes in parents’ self-reporting pro-sipping beliefs, 
attitudes, and practices at the end of the intervention period. 
 
3.2.1 3.2.1 Primary outcome measures 
 
For each participating parent, we will assess the change in composite score on an 8-item scale 
of self-reported pro-sipping beliefs, attitudes, and practices from baseline to 6 months (length 
of intervention). A four-point scale ranging from “strongly disagree” to “strongly agree” will be 
used, with higher values on the scale indicating a more pro-sipping belief system. 
 
3.2.2 3.2.2 Other measures 
 
No a priori secondary outcome measures. 
 
 

4 STUDY DESIGN 
 
This study will evaluate the BIPAS Alcohol intervention with approximately 100 families. Parents 
will be randomized after enrollment into two groups: an intervention group and a waitlist-
control group. Parents in the intervention group will begin receiving the intervention after 
enrollment, while parents in the waitlist-control group will receive the intervention three 
months after enrollment. 
 
During the intervention period, all parents will receive text messages 2-3 times/week and 
online resources for three months about alcohol use and negative consequences in children, 
focusing on ways that they can create rules within the family environment to prevent alcohol 
use in children.  
 
Parents in both groups will complete monthly surveys, and their child will complete one survey 
after three months. The parents in the intervention group will also receive a follow-up survey at 
6 months. Parents in both groups will be asked if they would like to participate in an optional, 
follow-up qualitative interview about their experiences participating in the intervention. 
 
 

5 STUDY ENROLLMENT AND WITHDRAWAL  
 
5.1 Subject inclusion criteria 
 
In order to be eligible to participate in this study, parents must: 
 
• Be aged 18 or older; 
• Be a parent or guardian of a child aged 10-12 years old; 
• 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 messaging capabilities and access to internet. 
 
5.2 Subject exclusion criteria 
 
Individuals will be excluded from participation if they do not meet study inclusion criteria. 
Additional exclusion criteria include: families in which the 10- to- 12- year-old child is actively 
receiving treatment for alcohol use disorder. 
 
5.3 Strategies for recruitment and retention 
 
Parents will primarily be recruited through flyers placed in elementary school electronic 
newsletters.  
 
The risk of this research is minimal risk to participants. We affirm this study will be conducted in 
accordance with sound ethical principles. Potential participants will be fully informed about the 
details of the study and encouraged to ask questions or stop at any time.  
 
5.4 Treatment assignment procedures 
 
5.4.1 Randomization procedures 
 
We will use a coin flip to determine which group parents will randomly be assigned to after 
enrollment.  
 
5.4.2 Masking procedures 
 
None.  
 
5.4.3 Reasons for withdrawal  
 

Participants who request to withdraw will be given the option to discontinue participation 
in the intervention. Participants who request to completely withdraw from the study will no 
longer be contacted.  
 
5.4.4 Handling of withdrawals  
 
See above. 
 
5.4.5 Termination of study 
 
Given the low-risk nature of this study, we do not anticipate grounds for premature 
termination. 
 
 
 

6 STUDY INTERVENTION 
 
6.1 Study intervention description 
 
The BIPAS Alcohol intervention offers education and tools to parents of children ages 10-12 
about preventing early onset alcohol use through information delivered via text message. 
Parents will receive text messages on early onset alcohol use, negative effects, and evidence-
based recommendations about encouraging discussion and rules with their child about alcohol. 
Text messages will be delivered 2-3 times/week for three months. 
 
Parents will complete a baseline survey as well as monthly surveys about alcohol-related 
beliefs, knowledge, and behaviors. Parents in the intervention group will also complete a 
follow-up survey six months after enrollment. 
 
6.2 Dosage, preparation, and administration of study intervention 
 
Each parent will receive text messages up to three times weekly and monthly surveys from our 
study team for a period of up to six months. 
 
6.3 Modification of study intervention for a subject 
 
Not applicable. 
 
6.4 Accountability procedures for the study intervention 
 
Not applicable.  
 
6.5 Assessment of subject compliance with study intervention 
 
Not applicable. 
 
6.6 Concomitant medications/treatments 
 
Not applicable. 
 
 

7 STUDY SCHEDULE 
 
7.1 Screening 
 
Parents who are interested in participating will complete an online pre-screening questionnaire. 
Eligible families will be contacted by a member of the study team and confirm eligibility over 
the phone. Screening of interested families will be conducted prior to informed consent. After 
enrollment, study participants will be given a baseline survey and provided with additional 
study instructions. Successful completion of the baseline questionnaire will demonstrate a 
willingness and ability to participate.   
 
7.2 Enrollment/baseline 
 
Enrollment and data collection will occur in 2023-2024. 
 
7.3 Follow-up 
 
Not applicable. 
 
7.4 Final study visit 
 
Not applicable. 
 
7.5 Early termination visit 
 
Not applicable. 
 
7.6 Unscheduled visit 
 
Not applicable. 
 
 

8 STATISTICAL CONSIDERATIONS 
 
8.1 Study hypotheses 
 
This is a feasibility trial designed to evaluate implementation outcomes and to obtain pilot data 
on efficacy of the intervention with a group of 100 parent-child dyads. We hypothesize that the 
BIPAS Alcohol intervention will increase parents’ knowledge and decrease their pro-sipping 
behaviors around adolescent alcohol. 
 
8.2 Sample size considerations 
 
We will test our hypothesis that the BIPAS Alcohol intervention will increase parents’ 
knowledge and decrease pro-sipping behaviors with 100 parents of 10-to-12-year-old children. 
We acknowledge that our trial is underpowered to detect small differences or control for 
multiple testing. One purpose of this feasibility study is to estimate effect sizes for powering a 
large-scale RCT. By piloting our intervention in two clinics, our study is designed to provide the 
data needed to lay this groundwork. 
 
8.3 Planned interim analyses (if applicable) 
 
Not applicable. 
 
8.4 Final analyses plan 
 
We will use generalized linear mixed models to model change in parent attitudes and behaviors 
over time as a function of treatment arm and baseline characteristics. We will handle missing 
data on survey outcomes using multilevel multiple imputation. Parameter estimates generated 
from these secondary analyses will be used for refining the intervention and for power analyses 
in a subsequent grant proposal.        
 
 
 

9 ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
9.1 Ethical standard 
 
The investigator will ensure that this study is conducted in full conformity with the principles 
set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 
and/or the ICH E6; 62 Federal Regulations 25691 (1997).  
 
9.2 Institutional Review Board 
 
Study procedures have been approved by the University of North Carolina Institutional Review 
Board. 
 
9.3 Informed consent process 
 
Informed consent will be obtained from all participating families prior to participation in 
baseline data collection. 
 
9.4 Exclusion of women, minorities, and children (special populations) 
 
Not applicable. 
 
9.5 Subject confidentiality  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their agents. The study team will take precautions to ensure 
that subject confidentiality is maintained. All data will be stripped of patient-level identifiers 
and stored on a password-protected server accessible only to UNC study staff. Data will be 
reported in aggregate and will not identify participating parents or children by name. 
 
9.6 Study discontinuation 
 
Not applicable. 
 
9.7 Future use of stored specimens 
 
Not applicable.