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Clinical Trials/NCT02600884
NCT02600884
Completed
N/A

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

The University of Texas Health Science Center, Houston1 site in 1 country1,183 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Increase HPV Vaccination Uptake
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
1183
Locations
1
Primary Endpoint
Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
April 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diane Santa Maria

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents

Time Frame: 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 intentions for sex as assessed by the FTT + HPV survey administered to youths

Time Frame: 6 months

Change in parent child communication as assessed by the FTT + HPV survey administered to parents

Time Frame: 6 months

Secondary Outcomes

  • 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)

Study Sites (1)

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