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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02600884
Enrollment
1183
Registered
2015-11-09
Start date
2015-09-30
Completion date
2019-04-30
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delay Sexual Debut, Increase HPV Vaccination Uptake

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.

Interventions

BEHAVIORALFamilies 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.

BEHAVIORALBrief 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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in parent child communication as assessed by the FTT + HPV survey administered to parents6 months
Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents1 monthThe 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 youths1 month

Secondary

MeasureTime frame
Change in parental involvement as assessed by the FTT + HPV survey administered to parents6 months
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents1 month
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents1 month
Change in parental monitoring as assessed by the FTT + HPV survey administered to parents1 month
Change in parental involvement as Assessed by the FTT + HPV survey administered to parents1 month
Change in sexual activity as assessed by the FTT + HPV survey administered to youths1 month
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths1 month
Change in parental communication as assessed by the FTT + HPV survey administered to youths1 month
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths1 month

Other

MeasureTime frame
Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses1 month
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses1 month
Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses1 month
Change in beliefs as assessed by the FTT + HPV survey administered to student nurses1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026