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Completed

NCT Number: NCT02600884

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.

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Key information

Conditions

Increase HPV Vaccination Uptake Delay Sexual Debut

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Families Talking Together Plus (FTT+HPV)

Behavioral

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.

Brief motivational interviewing (BMI)

Behavioral

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.

Primary outcomes

  1. 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.

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

    Time frame: 6 months

  3. Change in intentions for sex as assessed by the FTT + HPV survey administered to youths

    Time frame: 1 month

  4. Change in intentions for sex as assessed by the FTT + HPV survey administered to youths

    Time frame: 6 months

Secondary outcomes

  1. Change in parental monitoring as assessed by the FTT + HPV survey administered to parents

    Time frame: 1 month

  2. Change in parental monitoring as assessed by the FTT + HPV survey administered to parents

    Time frame: 6 months

  3. Change in parental involvement as Assessed by the FTT + HPV survey administered to parents

    Time frame: 1 month

  4. Change in parental involvement as assessed by the FTT + HPV survey administered to parents

    Time frame: 6 months

  5. Change in intentions for communication as assessed by the FTT + HPV survey administered to parents

    Time frame: 1 month

  6. Change in intentions for communication as assessed by the FTT + HPV survey administered to parents

    Time frame: 6 months

  7. Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents

    Time frame: 1 month

  8. Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents

    Time frame: 6 months

  9. Change in sexual activity as assessed by the FTT + HPV survey administered to youths

    Time frame: 1 month

  10. Change in sexual activity as assessed by the FTT + HPV survey administered to youths

    Time frame: 6 months

  11. Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths

    Time frame: 1 month

  12. Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths

    Time frame: 6 months

  13. Change in parental communication as assessed by the FTT + HPV survey administered to youths

    Time frame: 1 month

  14. Change in parental communication as assessed by the FTT + HPV survey administered to youths

    Time frame: 6 months

  15. Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths

    Time frame: 1 month

  16. Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths

    Time frame: 6 months

Other outcomes

  1. Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 1 month

  2. Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 6 months

  3. Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 1 month

  4. Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 6 months

  5. Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 1 month

  6. Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 6 months

  7. Change in beliefs as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 1 month

  8. Change in beliefs as assessed by the FTT + HPV survey administered to student nurses

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 9, 2015
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.