Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention

Not Applicable

Completed

• Conditions: Increase HPV Vaccination Uptake; Delay Sexual Debut
• Interventions: Behavioral: Families Talking Together Plus (FTT+HPV); Behavioral: Brief motivational interviewing (BMI)

• Registration Number: NCT02600884
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this research study is to evaluate a brief parent-based adolescent sexual health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an established intervention called Families Talking Together (FTT) and will enhance FTT by adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether FTT will help parents increase sexual health communication, delay adolescent sexual debut, and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be delivered by student nurses.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-09
• Primary Completion: 2018-11
• Study Completion: 2019-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1183

Inclusion Criteria

• Parent: resides with a child 11-14 years old who attends a participating community center, after-school program, or Boys and Girls Club (BGC)
• Parent: available for a face-to-face or small group session with the PI or student nurse within 2 months of consenting and assenting to participate in the study
• Parent: can read, write, and speak English or Spanish
• Child: between 11-14 years of age

Exclusion Criteria

• Parent: Without primary custody of child
• Parent: Incarcerated
• Parent: Unable to attend a face-to-face session within 2 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Families Talking Together Plus (FTT+HPV)	Families Talking Together Plus (FTT+HPV)	Parents in the experimental group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the experimental intervention includes parent-child sexual health communication and HPV vaccination navigation.
Brief motivational interviewing (BMI)	Brief motivational interviewing (BMI)	Parents in the brief motivational interviewing (BMI) group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.

Primary Outcome Measures

Name	Time	Method
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths	6 months
Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents	1 month	The FTT + HPV survey is a survey that has been developed by the investigator for this study. The survey is administered at baseline, 1, and 6 months using iPads and is available as Audio Computer-Assisted Self-Interviews in both English and Spanish.
Change in parent child communication as assessed by the FTT + HPV survey administered to parents	6 months

Secondary Outcome Measures

Name	Time	Method
Change in parental involvement as Assessed by the FTT + HPV survey administered to parents	1 month
Change in parental communication as assessed by the FTT + HPV survey administered to youths	6 months
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents	6 months
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents	6 months
Change in parental involvement as assessed by the FTT + HPV survey administered to parents	6 months
Change in sexual activity as assessed by the FTT + HPV survey administered to youths	6 months
Change in parental monitoring as assessed by the FTT + HPV survey administered to parents	6 months
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths	6 months
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths	6 months

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States