跳至主要内容
临床试验/NCT04731649
NCT04731649已完成不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 1,227 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,227
试验地点
2
主要终点
Sexual Debut/Ever Sex (Vaginal)

研究概览

简要总结

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."

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Sexual Debut/Ever Sex (Vaginal)

时间窗: 9-month post-intervention

Defined as adolescent report of having engaged in vaginal sex.

Sexual Debut/Ever Sex (Anal)

时间窗: 9-month post-intervention

Defined as adolescent report of having engaged in anal sex.

Sexual Debut/Ever Sex (Oral)

时间窗: 9-month post-intervention

Defined as adolescent report of having engaged in oral sex.

次要结局

  • Uptake of Sexually Transmitted Infection (STI) Testing(9-month post-intervention)
  • Frequency of Vaginal Sex Acts(3-month post-intervention)
  • Frequency of Anal Sex Acts(3-month post-intervention)
  • Frequency of Oral Sex Acts(3-month post-intervention)
  • Number of Sexual Partners(3-month post-intervention)
  • Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale(3-month post-intervention)
  • Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale(3-month post-intervention)
  • Sexual Debut/Ever Sex (Vaginal)(3-month post-intervention)
  • Sexual Debut/Ever Sex (Anal)(3-month post-intervention)
  • Sexual Debut/Ever Sex (Oral)(3-month post-intervention)
  • Uptake of STI Testing(3-month post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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