Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05071989 - The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT03685643 - Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults N/A
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Active, not recruiting NCT05926141 - Advanced Cooking Education Pilot Study N/A
Recruiting NCT04317547 - Translation Study of a Safe Teen Driving Intervention N/A
Recruiting NCT06001892 - Tennessee Youth Prepared for Success N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Not yet recruiting NCT06310434 - Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Terminated NCT02578147 - JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls N/A
Active, not recruiting NCT02329015 - Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools Phase 1
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Completed NCT01433679 - The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents N/A
Completed NCT00056953 - Peer Mentors for Adolescents in HIV Affected Families Phase 2