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

The University of Texas System (UT)

Status: Completed

Conditions: Increase HPV Vaccination Uptake; Delay Sexual Debut

Treatments: Behavioral: Brief motivational interviewing (BMI); Behavioral: Families Talking Together Plus (FTT+HPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT02600884

HSC-SN-15-0091

Details and patient eligibility

About

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.

Enrollment: 1,183 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,183 participants in 2 patient groups

Families Talking Together Plus (FTT+HPV)

Experimental group

Description:

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.

Treatment:

Behavioral: Families Talking Together Plus (FTT+HPV)

Brief motivational interviewing (BMI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brief motivational interviewing (BMI)