Fathers Raising Responsible Men (FRRM): Addressing Sexual Health (FRRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03429985|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Behavior and Behavior Mechanisms||Behavioral: FRRM Intervention||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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
- 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
- Adolescent Frequency of Sex Acts [ Time Frame: Immediate follow up (3 months) ]Defined as number of sex acts within a time period
- 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
- 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
- Adolescent HIV Testing Results [ Time Frame: Immediate follow up (3 months) ]Defined as the prevalence of HIV at follow-up
- Adolescent Gonorrhea Testing Results [ Time Frame: Immediate follow up (3 months) ]Defined as the prevalence of gonorrhea at follow-up
- Adolescent Chlamydia Testing Results [ Time Frame: Immediate follow up (3 months) ]Defined as the prevalence of chalmydia at follow-up
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
|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 firstname.lastname@example.org|
|Contact: Adam Benzekri 212-992-6797 email@example.com|
|Principal Investigator: Vincent Guilamo-Ramos, PhD|