NCT02600884|Completed
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Sponsor study identifier
interventional
1,183
1 country
1
Study Start
September 2015
Actual (reported)Primary Completion
November 2018
Actual (reported)Study Completion
April 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Actual (reported)November 5, 2015
Actual (reported)November 9, 2015
Actual (reported)November 2018
Actual (reported)April 2019
Actual (reported)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
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 confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses
1 month
Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses
6 months
Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses
1 month
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.
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.
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.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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.
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.
Diane Santa Maria, DrPH
The University of Texas Health Science Center, Houston
1,183 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
September 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2018
Actual (reported)Study Completion
April 2019
Actual (reported)Last Updated
November 3, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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