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

Behavior and Behavior Mechanisms Clinical Trial

— FTT+  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04731649
• Other study ID #: IRB00426772
• Secondary ID: 90SR0113-01-00PR
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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."

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1227
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

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.

Locations

Country	Name	City	State
United States	Duke University School of Nursing	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Debut/Ever Sex (Vaginal)	Defined as adolescent report of having engaged in vaginal sex.	9-month post-intervention
Primary	Sexual Debut/Ever Sex (Anal)	Defined as adolescent report of having engaged in anal sex.	9-month post-intervention
Primary	Sexual Debut/Ever Sex (Oral)	Defined as adolescent report of having engaged in oral sex.	9-month post-intervention
Secondary	Frequency of Vaginal Sex Acts	Defined as number of vaginal sex acts within a 6-month period	9-month post-intervention
Secondary	Frequency of Anal Sex Acts	Defined as number of anal sex acts within a 6-month period	9-month post-intervention
Secondary	Frequency of Oral Sex Acts	Defined as number of oral sex acts within a 6-month period	9-month post-intervention
Secondary	Number of Sexual Partners	Defined as the number of different sexual partners within a 6-month period	9-month post-intervention
Secondary	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
Secondary	Uptake of Sexually Transmitted Infection (STI) Testing	Defined as adolescent report of utilizing STI testing.	9-month post-intervention
Secondary	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
Secondary	Sexual Debut/Ever Sex (Vaginal)	Defined as adolescent report of having engaged in vaginal sex.	3-month post-intervention
Secondary	Sexual Debut/Ever Sex (Anal)	Defined as adolescent report of having engaged in anal sex.	3-month post-intervention
Secondary	Sexual Debut/Ever Sex (Oral)	Defined as adolescent report of having engaged in oral sex.	3-month post-intervention
Secondary	Frequency of Vaginal Sex Acts	Defined as number of vaginal sex acts within a 3-month period	3-month post-intervention
Secondary	Frequency of Anal Sex Acts	Defined as number of anal sex acts within a 3-month period	3-month post-intervention
Secondary	Frequency of Oral Sex Acts	Defined as number of oral sex acts within a 3-month period	3-month post-intervention
Secondary	Number of Sexual Partners	Defined as the number of different sexual partners within a 3-month period	3-month post-intervention
Secondary	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
Secondary	Uptake of STI Testing	Defined as adolescent report of utilizing STI testing.	3-month post-intervention
Secondary	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

External Links

•   Study Protocol