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

October 9, 2024 updated by: Johns Hopkins University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1227

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Adam Benzekri, MPH
  • Phone Number: 833-774-1799
  • Email: ab917@duke.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual Debut/Ever Sex (Vaginal)
Time Frame: 9-month post-intervention
Defined as adolescent report of having engaged in vaginal sex.
9-month post-intervention
Sexual Debut/Ever Sex (Anal)
Time Frame: 9-month post-intervention
Defined as adolescent report of having engaged in anal sex.
9-month post-intervention
Sexual Debut/Ever Sex (Oral)
Time Frame: 9-month post-intervention
Defined as adolescent report of having engaged in oral sex.
9-month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Vaginal Sex Acts
Time Frame: 9-month post-intervention
Defined as number of vaginal sex acts within a 6-month period
9-month post-intervention
Frequency of Anal Sex Acts
Time Frame: 9-month post-intervention
Defined as number of anal sex acts within a 6-month period
9-month post-intervention
Frequency of Oral Sex Acts
Time Frame: 9-month post-intervention
Defined as number of oral sex acts within a 6-month period
9-month post-intervention
Number of Sexual Partners
Time Frame: 9-month post-intervention
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
Time Frame: 9-month post-intervention
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
Time Frame: 9-month post-intervention
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)
Time Frame: 3-month post-intervention
Defined as adolescent report of having engaged in vaginal sex.
3-month post-intervention
Sexual Debut/Ever Sex (Anal)
Time Frame: 3-month post-intervention
Defined as adolescent report of having engaged in anal sex.
3-month post-intervention
Sexual Debut/Ever Sex (Oral)
Time Frame: 3-month post-intervention
Defined as adolescent report of having engaged in oral sex.
3-month post-intervention
Frequency of Vaginal Sex Acts
Time Frame: 3-month post-intervention
Defined as number of vaginal sex acts within a 3-month period
3-month post-intervention
Frequency of Anal Sex Acts
Time Frame: 3-month post-intervention
Defined as number of anal sex acts within a 3-month period
3-month post-intervention
Frequency of Oral Sex Acts
Time Frame: 3-month post-intervention
Defined as number of oral sex acts within a 3-month period
3-month post-intervention
Number of Sexual Partners
Time Frame: 3-month post-intervention
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
Time Frame: 3-month post-intervention
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
Time Frame: 3-month post-intervention
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
Time Frame: 3-month post-intervention
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
Time Frame: 9-month post-intervention
Defined as adolescent report of utilizing STI testing.
9-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincent Guilamo-Ramos, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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