Fathers Raising Responsible Men (FRRM): Addressing Sexual Health

Behavior and Behavior Mechanisms Clinical Trial

— FRRM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03429985
• Other study ID #: PRO00108880
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 382
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

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.

Locations

Country	Name	City	State
United States	Duke University School of Nursing	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Adolescent Frequency of Sex Acts	Defined as number of sex acts within a time period	Delayed follow up (9 months)
Secondary	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)
Secondary	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)
Secondary	Adolescent HIV Testing Results	Defined as the prevalence of HIV at follow-up	Delayed follow up (9 months)
Secondary	Adolescent Gonorrhea Testing Results	Defined as the prevalence of gonorrhea at follow-up	Delayed follow up (9 months)
Secondary	Adolescent Chlamydia Testing Results	Defined as the prevalence of chlamydia at follow-up	Delayed follow up (9 months)
Secondary	Adolescent Attendance at Job Training Services	Defined as adolescent report of having attended a job training services visit	Delayed follow up (9 months)
Secondary	Adolescent Attendance at Educational Support Services	Defined as adolescent report of having attended an educational support services visit	Delayed follow up (9 months)
Secondary	Adolescent Attendance at Wraparound Services	Defined as adolescent report of having attended a wraparound services visit	Delayed follow up (9 months)
Secondary	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)
Secondary	Number of Unprotected Sex Acts Among Adolescent Males	Defined as number of sex acts without using a contraceptive method	Immediate follow up (3 months)
Secondary	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)
Secondary	Adolescent Frequency of Sex Acts	Defined as number of sex acts within a time period	Immediate follow up (3 months)
Secondary	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)
Secondary	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)
Secondary	Adolescent HIV Testing Results	Defined as the prevalence of HIV at follow-up	Immediate follow up (3 months)
Secondary	Adolescent Gonorrhea Testing Results	Defined as the prevalence of gonorrhea at follow-up	Immediate follow up (3 months)
Secondary	Adolescent Chlamydia Testing Results	Defined as the prevalence of chlamydia at follow-up	Immediate follow up (3 months)