Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03429985
Status:
TERMINATED
Last Update Posted:
2023-08-25
First Post:
2017-09-15
Brief Title:
Fathers Raising Responsible Men FRRM Addressing Sexual Health
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Fathers Raising Responsible Men FRRM Addressing Sexual Health to Reduce Teen Pregnancy
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In response to the COVID pandemic and in accordance with local and university public health restrictions our team suspended the study This disrupted all planned follow-up activities With funder approval we pivoted our project to a non-RCT design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRRM
Brief Summary:
While existing teen pregnancy prevention efforts have contributed to significant declines in the overall US 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 n200 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 n300 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 goalsaspirations
The RCT consists of two cohorts The first cohort n200 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 n300 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 goalsaspirations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None