Clinical trial NCT03429985: Fathers Raising Responsible Men (FRRM): Addressing Sexual Health
Official title: Fathers Raising Responsible Men (FRRM): Addressing Sexual Health to Reduce Teen Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: Sexual and Reproductive Health
Parent-based Intervention
Sexual Risk Behavior
Adolescent Males
Father-Son Intervention
Life Opportunities
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 382
Sex: MALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Unprotected Sex Acts Among Adolescent Males
timeFrame: Delayed follow up (9 months)
Secondary outcomes:
measure: Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: Delayed follow up (9 months)
measure: Adolescent Frequency of Sex Acts
timeFrame: Delayed follow up (9 months)
measure: Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: Delayed follow up (9 months)
measure: Adolescent Attendance at Sexual and Reproductive Health Service
timeFrame: Delayed follow up (9 months)
measure: Adolescent HIV Testing Results
timeFrame: Delayed follow up (9 months)
measure: Adolescent Gonorrhea Testing Results
timeFrame: Delayed follow up (9 months)
measure: Adolescent Chlamydia Testing Results
timeFrame: Delayed follow up (9 months)
measure: Adolescent Attendance at Job Training Services
timeFrame: Delayed follow up (9 months)
measure: Adolescent Attendance at Educational Support Services
timeFrame: Delayed follow up (9 months)
measure: Adolescent Attendance at Wraparound Services
timeFrame: Delayed follow up (9 months)
measure: Adolescent Perception of Future Academic and Career Success: As Measured by the Perceived Life Chances Scale
timeFrame: Delayed follow up (9 months)
measure: Number of Unprotected Sex Acts Among Adolescent Males
timeFrame: Immediate follow up (3 months)
measure: Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: Immediate follow up (3 months)
measure: Adolescent Frequency of Sex Acts
timeFrame: Immediate follow up (3 months)
measure: Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
timeFrame: Immediate follow up (3 months)
measure: Adolescent Attendance at Sexual and Reproductive Health Services
timeFrame: Immediate follow up (3 months)
measure: Adolescent HIV Testing Results
timeFrame: Immediate follow up (3 months)
measure: Adolescent Gonorrhea Testing Results
timeFrame: Immediate follow up (3 months)
measure: Adolescent Chlamydia Testing Results
timeFrame: Immediate follow up (3 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Duke University School of Nursing
state: New York
Study officials:
References: