An interventional study of FRRM Intervention in Behavior and Behavior Mechanisms, sponsored by Duke University. Terminated at 1 site in United States. Open to male participants aged 15 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
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.
To be eligible for the study, adolescent sons must:
Eligible fathers must:
Exclusion Criteria:
Both fathers and sons must not be participating in any other teen pregnancy prevention program at the start of the study.
The experimental arm will receive the FRRM intervention.
Behavioral: FRRM Intervention
The control arm will not receive the FRRM intervention.
Fathers Raising Responsible Men (FRRM) is designed to facilitate important paternal parenting behaviors that influence adolescent decision-making. FRRM incorporates a novel, theoretically-based intervention highlighting the important and influential role that fathers have on the development and life trajectories of adolescent males.
Also known as: FRRM
Number of Unprotected Sex Acts Among Adolescent Males
Defined as number of sex acts without using a contraceptive method
Time frame: Delayed follow up (9 months)
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as frequency of adolescent condom use during sex acts
Time frame: Delayed follow up (9 months)
Adolescent Frequency of Sex Acts
Defined as number of sex acts within a time period
Time frame: Delayed follow up (9 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as adolescent knowledge of the correct steps of using a condom, with higher scores indicating greater knowledge of the five steps of condom use.
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Sexual and Reproductive Health Service
Defined as adolescent report of having attended a sexual and reproductive health visit
Time frame: Delayed follow up (9 months)
Adolescent HIV Testing Results
Defined as the prevalence of HIV at follow-up
Time frame: Delayed follow up (9 months)
Adolescent Gonorrhea Testing Results
Defined as the prevalence of gonorrhea at follow-up
Time frame: Delayed follow up (9 months)
Adolescent Chlamydia Testing Results
Defined as the prevalence of chlamydia at follow-up
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Job Training Services
Defined as adolescent report of having attended a job training services visit
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Educational Support Services
Defined as adolescent report of having attended an educational support services visit
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Wraparound Services
Defined as adolescent report of having attended a wraparound services visit
Time frame: Delayed follow up (9 months)
Adolescent Perception of Future Academic and Career Success: As Measured by the Perceived Life Chances Scale
Defined as adolescent report of their perceived likelihood of achieving future goals and aspirations, with higher scores indicating greater perceived likelihood of achieving long-term goals.
Time frame: Delayed follow up (9 months)
Number of Unprotected Sex Acts Among Adolescent Males
Defined as number of sex acts without using a contraceptive method
Time frame: Immediate follow up (3 months)
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as the proportion of total sex acts where a condom was used, with higher scores indicating a greater percentage of condom use.
Time frame: Immediate follow up (3 months)
Adolescent Frequency of Sex Acts
Defined as number of sex acts within a time period
Time frame: Immediate follow up (3 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as adolescent knowledge of the correct steps of using a condom, with higher scores indicating greater knowledge of the five steps of condom use.
Time frame: Immediate follow up (3 months)
Adolescent Attendance at Sexual and Reproductive Health Services
Defined as adolescent report of having attended a sexual and reproductive health visit
Time frame: Immediate follow up (3 months)
Adolescent HIV Testing Results
Defined as the prevalence of HIV at follow-up
Time frame: Immediate follow up (3 months)
Adolescent Gonorrhea Testing Results
Defined as the prevalence of gonorrhea at follow-up
Time frame: Immediate follow up (3 months)
Adolescent Chlamydia Testing Results
Defined as the prevalence of chlamydia at follow-up
Time frame: Immediate follow up (3 months)
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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