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

Study Overview
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Brief Summary
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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.

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

Conditions
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Increase HPV Vaccination Uptake, Delay Sexual Debut

Intervention / Treatment
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* Behavioral: Families Talking Together Plus (FTT+HPV)
* Behavioral: Brief motivational interviewing (BMI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families Talking Together Plus (FTT+HPV)<br>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)<br>* 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.<br>|
| Active Comparator: Brief motivational interviewing (BMI)<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 |