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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Age limit for parents: minimum = N/A (No limit); maximum = N/A (No limit) Age limit for children: minimum = 11 years; maximum = 14 years

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Families Talking Together Plus (FTT+HPV); Intervention parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the experimental intervention includes parent child sexual health communication and HPV vaccination navigation.
Active Comparator: 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.	Behavioral: Brief motivational interviewing (BMI); Control parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents	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.	1 month
Change in parent child communication as assessed by the FTT + HPV survey administered to parents		6 months
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths		1 month
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths		6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses	1 month
Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses	6 months
Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses	1 month
Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses	6 months
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses	1 month
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses	6 months
Change in beliefs as assessed by the FTT + HPV survey administered to student nurses	1 month
Change in beliefs as assessed by the FTT + HPV survey administered to student nurses	6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Diane Santa Maria, DrPH, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Santa Maria D, Markham C, Misra SM, Coleman DC, Lyons M, Desormeaux C, Cron S, Guilamo-Ramos V. Effects of a randomized controlled trial of a brief, student-nurse led, parent-based sexual health intervention on parental protective factors and HPV vaccination uptake. BMC Public Health. 2021 Mar 24;21(1):585. doi: 10.1186/s12889-021-10534-0.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimated): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SN-15-0091