Trial Outcomes & Findings for Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol) (NCT NCT05520333)

NCT ID: NCT05520333

Last Updated: 2025-06-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

Baseline, three months

Results posted on

2025-06-08

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Intervention Arm Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months.	Waitlist-control Arm Families are randomized into a waitlist control group for three months and begin receiving text messages for three months.
Overall Study STARTED	69	63
Overall Study COMPLETED	66	57
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months.	Waitlist-control Arm Families are randomized into a waitlist control group for three months and begin receiving text messages for three months.
Overall Study Lost to Follow-up	3	6

Baseline Characteristics

The study was not designed to collect these data; therefore, sex data were not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=69 Participants Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months.	Waitlist-control Arm n=63 Participants Families are randomized into a control group for three months and begin receiving text messages for three months.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=69 Participants	0 Participants n=63 Participants	0 Participants n=132 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=69 Participants	63 Participants n=63 Participants	132 Participants n=132 Participants
Age, Categorical >=65 years	0 Participants n=69 Participants	0 Participants n=63 Participants	0 Participants n=132 Participants
Sex: Female, Male Female	—	—	0 Participants The study was not designed to collect these data; therefore, sex data were not collected.
Sex: Female, Male Male	—	—	0 Participants The study was not designed to collect these data; therefore, sex data were not collected.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=69 Participants	3 Participants n=63 Participants	6 Participants n=132 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=69 Participants	57 Participants n=63 Participants	123 Participants n=132 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=69 Participants	3 Participants n=63 Participants	3 Participants n=132 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=69 Participants	0 Participants n=63 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Asian	3 Participants n=69 Participants	5 Participants n=63 Participants	8 Participants n=132 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=69 Participants	0 Participants n=63 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Black or African American	3 Participants n=69 Participants	0 Participants n=63 Participants	3 Participants n=132 Participants
Race (NIH/OMB) White	61 Participants n=69 Participants	52 Participants n=63 Participants	113 Participants n=132 Participants
Race (NIH/OMB) More than one race	1 Participants n=69 Participants	2 Participants n=63 Participants	3 Participants n=132 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=69 Participants	4 Participants n=63 Participants	5 Participants n=132 Participants
Parent drinks alcohol Yes	56 Participants n=69 Participants	47 Participants n=63 Participants	103 Participants n=132 Participants
Parent drinks alcohol No	13 Participants n=69 Participants	16 Participants n=63 Participants	29 Participants n=132 Participants
Parent/guardian relationship with child Mother	61 Participants n=69 Participants	54 Participants n=63 Participants	115 Participants n=132 Participants
Parent/guardian relationship with child Father	8 Participants n=69 Participants	8 Participants n=63 Participants	16 Participants n=132 Participants
Parent/guardian relationship with child Guardian	0 Participants n=69 Participants	1 Participants n=63 Participants	1 Participants n=132 Participants

PRIMARY outcome

Timeframe: Baseline, three months

Outcome measures

Outcome measures
Measure	Intervention Arm n=66 Participants Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months.	Waitlist-control Arm n=57 Participants Families are randomized into a waitlist control group for three months and begin receiving text messages for three months.
Change in Mean Value of Parental Pro-sipping Beliefs Score	0.13 score on a scale Standard Deviation 0.14	0.08 score on a scale Standard Deviation 0.16

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist-control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nisha Gottfredson O'Shea

RTI International

Phone: 9192481826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place