Clinical trial NCT04731649: Families Talking Together Plus: An Approach to Promote Sexual Delay and Strengthen Sexual Risk Avoidance Education
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: Families Talking Together
Adolescent Sexual Health
Community Health Workers
Prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 1227
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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."

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual Debut/Ever Sex (Vaginal)
timeFrame: 9-month post-intervention
measure: Sexual Debut/Ever Sex (Anal)
timeFrame: 9-month post-intervention
measure: Sexual Debut/Ever Sex (Oral)
timeFrame: 9-month post-intervention
Secondary outcomes:
measure: Frequency of Vaginal Sex Acts
timeFrame: 9-month post-intervention
measure: Frequency of Anal Sex Acts
timeFrame: 9-month post-intervention
measure: Frequency of Oral Sex Acts
timeFrame: 9-month post-intervention
measure: Number of Sexual Partners
timeFrame: 9-month post-intervention
measure: Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: 9-month post-intervention
measure: Uptake of Sexually Transmitted Infection (STI) Testing
timeFrame: 9-month post-intervention
measure: Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
timeFrame: 9-month post-intervention
measure: Sexual Debut/Ever Sex (Vaginal)
timeFrame: 3-month post-intervention
measure: Sexual Debut/Ever Sex (Anal)
timeFrame: 3-month post-intervention
measure: Sexual Debut/Ever Sex (Oral)
timeFrame: 3-month post-intervention
measure: Frequency of Vaginal Sex Acts
timeFrame: 3-month post-intervention
measure: Frequency of Anal Sex Acts
timeFrame: 3-month post-intervention
measure: Frequency of Oral Sex Acts
timeFrame: 3-month post-intervention
measure: Number of Sexual Partners
timeFrame: 3-month post-intervention
measure: Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: 3-month post-intervention
measure: Uptake of STI Testing
timeFrame: 3-month post-intervention
measure: Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
timeFrame: 3-month post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Johns Hopkins University
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Vincent Guilamo-Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References: