Clinical trial NCT02600884: Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention
Official title: Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increase HPV Vaccination Uptake
Delay Sexual Debut
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 1183
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents
timeFrame: 1 month
measure: Change in parent child communication as assessed by the FTT + HPV survey administered to parents
timeFrame: 6 months
measure: Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
timeFrame: 1 month
measure: Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
timeFrame: 6 months
Secondary outcomes:
measure: Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
timeFrame: 1 month
measure: Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
timeFrame: 6 months
measure: Change in parental involvement as Assessed by the FTT + HPV survey administered to parents
timeFrame: 1 month
measure: Change in parental involvement as assessed by the FTT + HPV survey administered to parents
timeFrame: 6 months
measure: Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
timeFrame: 1 month
measure: Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
timeFrame: 6 months
measure: Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
timeFrame: 1 month
measure: Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
timeFrame: 6 months
measure: Change in sexual activity as assessed by the FTT + HPV survey administered to youths
timeFrame: 1 month
measure: Change in sexual activity as assessed by the FTT + HPV survey administered to youths
timeFrame: 6 months
measure: Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
timeFrame: 1 month
measure: Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
timeFrame: 6 months
measure: Change in parental communication as assessed by the FTT + HPV survey administered to youths
timeFrame: 1 month
measure: Change in parental communication as assessed by the FTT + HPV survey administered to youths
timeFrame: 6 months
measure: Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
timeFrame: 1 month
measure: Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
timeFrame: 6 months
Other outcomes:
measure: Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 1 month
measure: Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 6 months
measure: Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 1 month
measure: Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 6 months
measure: Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 1 month
measure: Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 6 months
measure: Change in beliefs as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 1 month
measure: Change in beliefs as assessed by the FTT + HPV survey administered to student nurses
timeFrame: 6 months
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Diane Santa Maria, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.