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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05520333
Other study ID # 22-0101
Secondary ID 1R34AA028856-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date August 2024

Study information

Verified date July 2023
Source University of North Carolina, Chapel Hill
Contact Nisha Gottfredson O'Shea, PhD
Phone 919-248-1826
Email nishaoshea@rti.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
BIPAS Alcohol
Weekly text messages for three months.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 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. Baseline, three months
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