Fathers Raising Responsible Men (FRRM): Addressing Sexual Health

NCT03429985 | Terminated

• 1 other identifier: PRO00108880
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior and Behavior Mechanisms

Keywords

Sexual and Reproductive Health; Parent-based Intervention; Sexual Risk Behavior; Adolescent Males; Father-Son Intervention; Life Opportunities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale

  Delayed follow up (9 months)

• Adolescent Frequency of Sex Acts

  Delayed follow up (9 months)

• Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale

  Delayed follow up (9 months)

• Adolescent Attendance at Sexual and Reproductive Health Service

  Delayed follow up (9 months)

• Adolescent HIV Testing Results

  Delayed follow up (9 months)

Study Arms (2)

FRRM Intervention

EXPERIMENTAL

The experimental arm will receive the FRRM intervention.

Behavioral: FRRM Intervention

Control

NO INTERVENTION

The control arm will not receive the FRRM intervention.

Interventions

FRRM Intervention BEHAVIORAL

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

FRRM Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University School of Nursing

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Behavior; Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: February 12, 2018
• Study Start: January 3, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

US (1)