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Trial record 12 of 15 for:    Recruiting, Not yet recruiting, Available Studies | "Pregnancy in Adolescence"

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

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ClinicalTrials.gov Identifier: NCT03429985
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
New York University

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 500 dyads to rigorously evaluate the intervention. 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.

Condition or disease Intervention/treatment Phase
Behavior and Behavior Mechanisms Behavioral: FRRM Intervention Not Applicable

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. The goals of the program are to reduce the number of unprotected sex acts among adolescent males through (1) improved knowledge about correct and consistent condom use, (2) increased sexually transmitted infection (STI) testing, and (3) increased utilization of sexual and reproductive health services.

The program consists of two 60 to 90 minute intervention sessions delivered to the father by project staff. Both 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. Intervention staff provide fathers with a FRRM Workbook and Toolkit, as well as a condom demonstration video that outlines the important steps for correct and consistent condom use. Fathers will use these materials to communicate with their adolescent sons as well as teach correct condom use and how best to access sexual and reproductive health services.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fathers Raising Responsible Men (FRRM): Addressing Sexual Health to Reduce Teen Pregnancy
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : June 12, 2019
Estimated Study Completion Date : June 12, 2019

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 of adolescent males.
Other Name: FRRM

No Intervention: Control
The control arm will not receive the FRRM intervention.



Primary Outcome Measures :
  1. Number of Unprotected Sex Acts Among Adolescent Males [ Time Frame: Immediate follow up (3 months) ]
    Defined as number of sex acts without using a contraceptive method


Secondary Outcome Measures :
  1. Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale [ Time Frame: Immediate follow up (3 months) ]
    Defined as frequency of adolescent condom use during sex acts

  2. Adolescent Frequency of Sex Acts [ Time Frame: Immediate follow up (3 months) ]
    Defined as number of sex acts within a time period

  3. Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale [ Time Frame: Immediate follow up (3 months) ]
    Defined as adolescent knowledge of the correct steps of using a condom

  4. Adolescent Attendance at Sexual and Reproductive Health Services [ Time Frame: Immediate follow up (3 months) ]
    Defined as adolescent report of having attended a sexual and reproductive health visit

  5. Adolescent HIV Testing Results [ Time Frame: Immediate follow up (3 months) ]
    Defined as the prevalence of HIV at follow-up

  6. Adolescent Gonorrhea Testing Results [ Time Frame: Immediate follow up (3 months) ]
    Defined as the prevalence of gonorrhea at follow-up

  7. Adolescent Chlamydia Testing Results [ Time Frame: Immediate follow up (3 months) ]
    Defined as the prevalence of chalmydia at follow-up



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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429985


Locations
United States, New York
New York University, Silver School of Social Work Recruiting
New York, New York, United States, 10003
Contact: Vincent Guilamo-Ramos, PhD    212-998-5981    vincent.ramos@nyu.edu   
Contact: Adam Benzekri    212-992-6797    ab7170@nyu.edu   
Principal Investigator: Vincent Guilamo-Ramos, PhD         
Sponsors and Collaborators
New York University

Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT03429985     History of Changes
Other Study ID Numbers: 1U01DP006106-01 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University:
Sexual and Reproductive Health
Parent-based Intervention
Sexual risk behavior
Adolescent males
Father-son Intervention