Fathers Raising Responsible Men (FRRM): Addressing Sexual Health (FRRM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: FRRM Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Duke University School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be eligible for the study, adolescent sons must:

1. be 15 to 19 year old male,
2. identify as either African American or Latino,
3. reside in one of the four target neighborhoods in the South Bronx, and
4. not be a teen father, married, or co-habitating with his partner.

Eligible fathers must:

1. be the primary caregiver who is male of the target son (this can include biological fathers, grandfathers, and uncles).
2. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FRRM Intervention; The experimental arm will receive the FRRM intervention.	Behavioral: 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.; Other Names: FRRM
No Intervention: Control; The control arm will not receive the FRRM intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Unprotected Sex Acts Among Adolescent Males	Defined as number of sex acts without using a contraceptive method	Delayed follow up (9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale	Defined as frequency of adolescent condom use during sex acts	Delayed follow up (9 months)
Adolescent Frequency of Sex Acts	Defined as number of sex acts within a time period	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.	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	Delayed follow up (9 months)
Adolescent HIV Testing Results	Defined as the prevalence of HIV at follow-up	Delayed follow up (9 months)
Adolescent Gonorrhea Testing Results	Defined as the prevalence of gonorrhea at follow-up	Delayed follow up (9 months)
Adolescent Chlamydia Testing Results	Defined as the prevalence of chlamydia at follow-up	Delayed follow up (9 months)
Adolescent Attendance at Job Training Services	Defined as adolescent report of having attended a job training services visit	Delayed follow up (9 months)
Adolescent Attendance at Educational Support Services	Defined as adolescent report of having attended an educational support services visit	Delayed follow up (9 months)
Adolescent Attendance at Wraparound Services	Defined as adolescent report of having attended a wraparound services visit	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.	Delayed follow up (9 months)
Number of Unprotected Sex Acts Among Adolescent Males	Defined as number of sex acts without using a contraceptive method	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.	Immediate follow up (3 months)
Adolescent Frequency of Sex Acts	Defined as number of sex acts within a time period	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.	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	Immediate follow up (3 months)
Adolescent HIV Testing Results	Defined as the prevalence of HIV at follow-up	Immediate follow up (3 months)
Adolescent Gonorrhea Testing Results	Defined as the prevalence of gonorrhea at follow-up	Immediate follow up (3 months)
Adolescent Chlamydia Testing Results	Defined as the prevalence of chlamydia at follow-up	Immediate follow up (3 months)

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Sexual and Reproductive Health; Sexual Risk Behavior; Parent-based Intervention; Adolescent Males; Father-Son Intervention; Life Opportunities
• Other Study ID Numbers: PRO00108880

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No