Adolescent Behavior, Alcohol Drinking, Adolescent, Drinking, Alcohol, Drinking Behavior
Conditions
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.
Interventions
BEHAVIORALBIPAS Alcohol
Weekly text messages for three months.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Parent-child dyads participated in this study, but only parents/caregivers were considered enrolled. The number started/completed reflects the number of individual parents/caregivers.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Families receive text messages for three months.
BIPAS Alcohol: Weekly text messages for three months. | 69 |
| Waitlist-control Arm Families are randomized into a control group for three months and begin receiving text messages for three months. | 63 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 |
Baseline characteristics
| Characteristic | Intervention Arm | Waitlist-control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 63 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 57 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Parent drinks alcohol No | 13 Participants | 16 Participants | 29 Participants |
| Parent drinks alcohol Yes | 56 Participants | 47 Participants | 103 Participants |
| Parent/guardian relationship with child Father | 8 Participants | 8 Participants | 16 Participants |
| Parent/guardian relationship with child Guardian | 0 Participants | 1 Participants | 1 Participants |
| Parent/guardian relationship with child Mother | 61 Participants | 54 Participants | 115 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 61 Participants | 52 Participants | 113 Participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Mean Value of Parental Pro-sipping Beliefs Score | 0.13 score on a scale | Standard Deviation 0.14 |
| Waitlist-control Arm | Change in Mean Value of Parental Pro-sipping Beliefs Score | 0.08 score on a scale | Standard Deviation 0.16 |