Families Talking Together Plus: An Approach to Promote Sexual Delay and Strengthen Sexual Risk Avoidance Education (FTT+)

Families Talking Together Plus (FTT+): An Online, Family-Based Approach to Promote Sexual Delay and Strengthen the Evidence-Base for Sexual Risk Avoidance Education

Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits. Needed are programmatic efforts to strengthen adolescent protective factors among populations in greatest need, with a particular emphasis on the important role of parents in promoting sexual delay. The proposed project is designed to target Latino and Black adolescents aged 12-17 years residing in the South Bronx, New York City, a high-need community for sexual risk programming and promotion of adolescent life opportunities. The investigators evaluate a program called Families Talking Together Plus (FTT+), an online, parent-based intervention that is medically accurate, culturally tailored, and age-appropriate. To implement FTT +, the investigators draw upon an innovative and culturally competent intervention delivery approach, namely community health workers (CHWs) as "Life Opportunity Coaches."

Study Overview

• Status: Completed
• Conditions: Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: Families Talking Together Plus (FTT +)

Detailed Description

Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. The adverse short and long-term consequences of premature adolescent sexual behavior are well-documented, including negative effects on the physical, emotional, social, and economic well-being of youth. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits.

Families Talking Together Plus (FTT +) is an online intervention designed to reduce adolescent sexual risk behavior through supporting caregiver-adolescent communication about sex. The goals of the program are to (1) delay sexual debut, (2) reduce sexual behavior, (3) increase correct and consistent condom use, and (4) increase engagement with community resources among Black and Latino adolescents aged 12-17 years (n=600) residing in a community with disparate adolescent SRH outcomes and high need for improved adolescent life opportunities and success sequencing support, the South Bronx, New York City.

The 2-arm parallel randomized controlled trial (RCT) will evaluate the efficacy of the FTT + intervention in delaying sexual debut, reducing adolescent sexual behavior, and linking adolescents to community resources and services for sexual risk behavior, PYD, and success sequencing. The investigators will recruit adolescents and the primary adult caregivers in the homes using area sampling methods piloted-tested by Center for Latino Adolescent and Family Health (CLAFH) staff with excellent results in our previous research in the target community. Parents and adolescents will complete a questionnaire (separately) at baseline assessments. Subsequently, parent-adolescent dyads will be randomly assigned to either, (1) the experimental group (who will receive the FTT + intervention), or (2) the control group that does not receive any intervention. The baseline sample size will be 600 dyads, with 300 dyads in each group.

Parents randomized to the experimental condition will receive three 60 to 90 minute virtual intervention sessions consisting of 9 modules delivered to the parent by community healthcare workers. Intervention sessions should happen within the first month following the baseline interview. FTT + modules address self-regulation, success sequencing, the benefits of delaying sex, correctly using a condom every time, healthy relationships, goal setting, resisting sexual coercion, dating violence, and other youth risk behaviors such as underage drinking or illicit drug use. In addition, parents receive guidance on effective adolescent monitoring and supervision and strengthening the relationship quality with the adolescent.

• Study Type: Interventional
• Enrollment (Actual): 1227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents must be between the ages of 12 and 17 years old
• Adolescent must identify as Latino or Black
• Adolescent has a primary caregiver
• Residence in Mott Haven, South Bronx

Exclusion Criteria:

• Adolescent is not between the ages of 12-17
• Adolescent is not Latino or Black
• Adolescent does not have a primary caregiver
• Non-resident of Mott Haven, South Bronx

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sex Education + Standard Care; The experimental arm will receive the FTT + intervention	Behavioral: Families Talking Together Plus (FTT +); FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time.
No Intervention: No Education + Standard Care; The control arm will not receive the FTT + intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Debut/Ever Sex (Vaginal)	Defined as adolescent report of having engaged in vaginal sex.	9-month post-intervention
Sexual Debut/Ever Sex (Anal)	Defined as adolescent report of having engaged in anal sex.	9-month post-intervention
Sexual Debut/Ever Sex (Oral)	Defined as adolescent report of having engaged in oral sex.	9-month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Vaginal Sex Acts	Defined as number of vaginal sex acts within a 6-month period	9-month post-intervention
Frequency of Anal Sex Acts	Defined as number of anal sex acts within a 6-month period	9-month post-intervention
Frequency of Oral Sex Acts	Defined as number of oral sex acts within a 6-month period	9-month post-intervention
Number of Sexual Partners	Defined as the number of different sexual partners within a 6-month period	9-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale	Defined as frequency of adolescent condom use during vaginal, anal, and oral sex acts, with higher scores indicating greater consistency of condom use [Minimum Score= 0% - indicates that no condom was used during any type of sex act in the past 6 months, Maximum Score= 100% - indicates that a new condom was used for every sex act in the past 6 months.	9-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale	Measured using the Utilization of Community Resources Scale, with higher scores indicating greater linkage to to services in the community addressing current needs (e.g., food insecurity) & economic capital (e.g., job training) [Minimum score = 0 - indicates no linkage to any services listed; Maximum score= 12- indicates linkage to all types of services listed in scale].	9-month post-intervention
Sexual Debut/Ever Sex (Vaginal)	Defined as adolescent report of having engaged in vaginal sex.	3-month post-intervention
Sexual Debut/Ever Sex (Anal)	Defined as adolescent report of having engaged in anal sex.	3-month post-intervention
Sexual Debut/Ever Sex (Oral)	Defined as adolescent report of having engaged in oral sex.	3-month post-intervention
Frequency of Vaginal Sex Acts	Defined as number of vaginal sex acts within a 3-month period	3-month post-intervention
Frequency of Anal Sex Acts	Defined as number of anal sex acts within a 3-month period	3-month post-intervention
Frequency of Oral Sex Acts	Defined as number of oral sex acts within a 3-month period	3-month post-intervention
Number of Sexual Partners	Defined as the number of different sexual partners within a 3-month period	3-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale	Defined as frequency of adolescent condom use during vaginal, anal, and oral sex acts, with higher scores indicating greater consistency of condom use [Minimum Score= 0% - indicating no condom use during any type of sex act in the past 3 months, Maximum Score= 100% - indicating condom use for every sex act in the past 3 months.	3-month post-intervention
Uptake of STI Testing	Defined as adolescent report of utilizing STI testing.	3-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale	Measured using the Utilization of Community Resources Scale, with higher scores indicating greater linkage to services in the community addressing current needs (e.g., food insecurity) & economic capital (e.g., job training) [.minimum score =0 - indicating no linkage to any services listed; maximum score=12- indicating linkage to all types of services listed in scale].	3-month post-intervention
Uptake of Sexually Transmitted Infection (STI) Testing	Defined as adolescent report of utilizing STI testing.	9-month post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Vincent Guilamo-Ramos, PhD, Johns Hopkins University

Publications and helpful links

Helpful Links

• Study Protocol

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Community Health Workers; Families Talking Together; Adolescent Sexual Health
• Other Study ID Numbers: IRB00426772; PRO00108607 (Other Identifier: Duke); 90SR0113-01-00 (Other Grant/Funding Number: Administration of Children and Families)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No