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临床试验/NCT03429985
NCT03429985终止不适用

Fathers Raising Responsible Men (FRRM): Addressing Sexual Health to Reduce Teen Pregnancy

Duke University2 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2018年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
382
试验地点
2
主要终点
Number of Unprotected Sex Acts Among Adolescent Males

研究概览

简要总结

While existing teen pregnancy prevention efforts have contributed to significant declines in the overall U.S. teen pregnancy rate, teen pregnancy prevention programs specifically targeting adolescent males are limited and sorely needed. The primary aim of the proposed research is to further develop, evaluate, and disseminate a teen pregnancy prevention program specifically designed for adolescent males to enhance the current scientific evidence and intervention options available for broad public health implementation. The proposed intervention Fathers Raising Responsible Men (FRRM) focuses on the adolescent male component of teen pregnancy by identifying and addressing adolescent risk and paternal protective behaviors specific to adolescent males that have not been fully addressed in previous prevention efforts. This study strives to reduce adolescent male sexual risk behavior through targeting African American and Latino adolescent males aged 15-19 and their fathers residing in the South Bronx, specifically Mott Haven and surrounding areas in three phases. Phase I is a pilot study consisting of eight dyads (fathers and sons) to test and refine the intervention and technical and training assistance needs. Phase II is the Randomized Control Trial (RCT) comprised of two cohorts (a total of 500 father-son dyads) to rigorously evaluate the intervention. During the final 6 months of the project, qualitative interviews with 30 father-son dyads will be conducted to triangulate the quantitative RCT results with participant experiences of FRRM. Finally, in Phase III the intervention will be refined and the intervention materials will be available to the general public, while findings will be widely disseminated. These three phases allow for the successful implementation and evaluation of FRRM in conjunction with the refinement and provision of all training and technical assistance necessary for the intervention. If successful, the proposed project will further develop the current scientific evidence and intervention options targeted specifically to the teen pregnancy prevention needs of African American and Latino adolescent males.

详细描述

FRRM is a male-focused intervention designed to reduce adolescent male sexual risk behavior through supporting father-son communication about sex and condoms, as well as improve future life trajectories. The goals of the program are to reduce the number of unprotected sex acts among adolescents through (1) improved knowledge about correct and consistent condom use, (2) increased sexual transmitted infection (STI) testing, and (3) increased utilization of sexual and reproductive health services. Additionally, the program aims to improve adolescent life opportunities through (1) improved perception of life trajectories; and (2) increased utilization of academic and job training services within the community.

The RCT consists of two cohorts. The first cohort (n=200 father-son dyads) will receive (1) two 60 to 90 minute intervention sessions delivered to the father by project staff. Intervention sessions should happen within the first month following the baseline interview. The first intervention session focuses on motivating fathers to communicate with their sons about sex and condom use, and the second session provides fathers with the skills and knowledge necessary to teach their sons about correct condom use. In addition, fathers receive guidance on effective adolescent monitoring and supervision and strengthening their relationship quality with their adolescent son.

The second cohort (n=300 father-son dyads) will receive (1) two 60 to 90 minute intervention sessions delivered to the father by project staff with content identical to the interventions given to cohort one; and 2) one 60 to 90 minute intervention session delivered to the father-son dyad by project staff regarding adolescent life opportunities. In the third intervention session, the father coach provides father-son dyads with specific guidance and helpful resources for on-going and positive interactions between fathers and sons. Additionally, this session highlights specific academic and job training resources within the community that fathers and sons can access to better address adolescent sexual and reproductive health, overall wellbeing, and future goals/aspirations.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • To be eligible for the study, adolescent sons must:
  • be 15 to 19 year old male,
  • identify as either African American or Latino,
  • reside in one of the four target neighborhoods in the South Bronx, and
  • not be a teen father, married, or co-habitating with his partner.
  • Eligible fathers must:
  • be the primary caregiver who is male of the target son (this can include biological fathers, grandfathers, and uncles).
  • Reside in Mott Haven or surrounding areas of the South Bronx or other parts of New York City; able to meet with son at son's primary residence or mutually agreed-upon location.

排除标准

  • Both fathers and sons must not be participating in any other teen pregnancy prevention program at the start of the study.

结局指标

主要结局

Number of Unprotected Sex Acts Among Adolescent Males

时间窗: Delayed follow up (9 months)

Defined as number of sex acts without using a contraceptive method

次要结局

  • Adolescent Attendance at Sexual and Reproductive Health Service(Delayed follow up (9 months))
  • Adolescent HIV Testing Results(Immediate follow up (3 months))
  • Adolescent Chlamydia Testing Results(Immediate follow up (3 months))
  • Adolescent Attendance at Educational Support Services(Delayed follow up (9 months))
  • Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale(Immediate follow up (3 months))
  • Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale(Immediate follow up (3 months))
  • Adolescent Frequency of Sex Acts(Immediate follow up (3 months))
  • Adolescent Attendance at Job Training Services(Delayed follow up (9 months))
  • Adolescent Perception of Future Academic and Career Success: As Measured by the Perceived Life Chances Scale(Delayed follow up (9 months))
  • Adolescent Gonorrhea Testing Results(Immediate follow up (3 months))
  • Adolescent Attendance at Sexual and Reproductive Health Services(Immediate follow up (3 months))
  • Number of Unprotected Sex Acts Among Adolescent Males(Immediate follow up (3 months))
  • Adolescent Attendance at Wraparound Services(Delayed follow up (9 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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