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

NCT ID: NCT02600884

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-04-30

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.

Detailed Description

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Conditions

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Increase HPV Vaccination Uptake Delay Sexual Debut

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Families Talking Together Plus (FTT+HPV)

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.

Group Type EXPERIMENTAL

Families Talking Together Plus (FTT+HPV)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Brief motivational interviewing (BMI)

Intervention Type 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.

Interventions

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Families 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.

Intervention Type BEHAVIORAL

Brief 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Diane Santa Maria

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane Santa Maria, DrPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Coleman DC, Frederick A, Cron S, Markham C, Guilamo-Ramos V, Santa Maria D. Impact of preparing nursing students to deliver a parent-based sexual health intervention on attitudes and intentions for sexual health education and parent communication counseling: a mixed methods study. BMC Nurs. 2023 Oct 10;22(1):375. doi: 10.1186/s12912-023-01531-2.

Reference Type DERIVED
PMID: 37817237 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33761920 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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HSC-SN-15-0091

Identifier Type: -

Identifier Source: org_study_id

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