Behavior and Behavior MechanismsFRRMNCT03429985
Fathers Raising Responsible Men (FRRM): Addressing Sexual Health
A study testing FRRM Intervention in people with Behavior and Behavior Mechanisms, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years, men only
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- FRRM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Both fathers and sons must not be participating in any other teen pregnancy prevention program at the start of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
New York, New York, 10017
About this study
Official title: Fathers Raising Responsible Men (FRRM): Addressing Sexual Health to Reduce Teen Pregnancy
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.
Read the 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.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- FRRM Intervention
- Keywords
- Sexual and Reproductive Health, Parent-based Intervention, Sexual Risk Behavior, Adolescent Males, Father-Son Intervention, Life Opportunities
- Medical subject headings
- Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRRM InterventionBehavioural
Also called FRRM
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.
| Study group | Role | What they receive |
|---|---|---|
| FRRM Intervention | Experimental | The experimental arm will receive the FRRM intervention. Receives: Behavioral: FRRM Intervention |
| Control | No intervention | The control arm will not receive the FRRM intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unprotected Sex Acts Among Adolescent Males
Defined as number of sex acts without using a contraceptive method
Measured: Delayed follow up (9 months)
Secondary outcomes (19)
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as frequency of adolescent condom use during sex acts
Measured: Delayed follow up (9 months)
Adolescent Frequency of Sex Acts
Defined as number of sex acts within a time period
Measured: Delayed follow up (9 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as adolescent knowledge of the correct steps of using a condom, with higher scores indicating greater knowledge of the five steps of condom use.
Measured: Delayed follow up (9 months)
Adolescent Attendance at Sexual and Reproductive Health Service
Defined as adolescent report of having attended a sexual and reproductive health visit
Measured: Delayed follow up (9 months)
Adolescent HIV Testing Results
Defined as the prevalence of HIV at follow-up
Measured: Delayed follow up (9 months)
Adolescent Gonorrhea Testing Results
Defined as the prevalence of gonorrhea at follow-up
Measured: Delayed follow up (9 months)
Adolescent Chlamydia Testing Results
Defined as the prevalence of chlamydia at follow-up
Measured: Delayed follow up (9 months)
Adolescent Attendance at Job Training Services
Defined as adolescent report of having attended a job training services visit
Measured: Delayed follow up (9 months)
Adolescent Attendance at Educational Support Services
Defined as adolescent report of having attended an educational support services visit
Measured: Delayed follow up (9 months)
Adolescent Attendance at Wraparound Services
Defined as adolescent report of having attended a wraparound services visit
Measured: Delayed follow up (9 months)
Adolescent Perception of Future Academic and Career Success: As Measured by the Perceived Life Chances Scale
Defined as adolescent report of their perceived likelihood of achieving future goals and aspirations, with higher scores indicating greater perceived likelihood of achieving long-term goals.
Measured: Delayed follow up (9 months)
Number of Unprotected Sex Acts Among Adolescent Males
Defined as number of sex acts without using a contraceptive method
Measured: Immediate follow up (3 months)
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as the proportion of total sex acts where a condom was used, with higher scores indicating a greater percentage of condom use.
Measured: Immediate follow up (3 months)
Adolescent Frequency of Sex Acts
Defined as number of sex acts within a time period
Measured: Immediate follow up (3 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as adolescent knowledge of the correct steps of using a condom, with higher scores indicating greater knowledge of the five steps of condom use.
Measured: Immediate follow up (3 months)
Adolescent Attendance at Sexual and Reproductive Health Services
Defined as adolescent report of having attended a sexual and reproductive health visit
Measured: Immediate follow up (3 months)
Adolescent HIV Testing Results
Defined as the prevalence of HIV at follow-up
Measured: Immediate follow up (3 months)
Adolescent Gonorrhea Testing Results
Defined as the prevalence of gonorrhea at follow-up
Measured: Immediate follow up (3 months)
Adolescent Chlamydia Testing Results
Defined as the prevalence of chlamydia at follow-up
Measured: Immediate follow up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start3 Jan 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429985
- Sponsor's protocol ID
- PRO00108880
- Acronym
- FRRM
- Status last verified
- Aug 2023
- First submitted
- 15 Sep 2017
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fathers Raising Responsible Men (FRRM): Addressing Sexual Health to Reduce Teen Pregnancy
- ClinicalTrials.gov ID
- NCT03429985
- Acronym / sponsor ID
- FRRM / PRO00108880
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- Sexual and Reproductive Health, Parent-based Intervention, Sexual Risk Behavior, Adolescent Males, Father-Son Intervention, Life Opportunities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRRM Intervention | Experimental | Behavioral: FRRM InterventionThe experimental arm will receive the FRRM intervention. |
| Control | No intervention | –The control arm will not receive the FRRM intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
- be the primary caregiver who is male of the target son (this can include biological fathers, grandfathers, and uncles).
Key exclusion criteria (1 listed)
- Both fathers and sons must not be participating in any other teen pregnancy prevention program at the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRRM InterventionAlso: FRRMFathers 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. | Behavioural | FRRM Intervention |
Primary outcome
Number of Unprotected Sex Acts Among Adolescent Males
Time frame: Delayed follow up (9 months)
Defined as number of sex acts without using a contraceptive method
19 secondary outcomes
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: Delayed follow up (9 months)
Adolescent Frequency of Sex Acts
Time frame: Delayed follow up (9 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Sexual and Reproductive Health Service
Time frame: Delayed follow up (9 months)
Adolescent HIV Testing Results
Time frame: Delayed follow up (9 months)
Adolescent Gonorrhea Testing Results
Time frame: Delayed follow up (9 months)
Adolescent Chlamydia Testing Results
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Job Training Services
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Educational Support Services
Time frame: Delayed follow up (9 months)
Adolescent Attendance at Wraparound Services
Time frame: Delayed follow up (9 months)
Adolescent Perception of Future Academic and Career Success: As Measured by the Perceived Life Chances Scale
Time frame: Delayed follow up (9 months)
Number of Unprotected Sex Acts Among Adolescent Males
Time frame: Immediate follow up (3 months)
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: Immediate follow up (3 months)
Adolescent Frequency of Sex Acts
Time frame: Immediate follow up (3 months)
Adolescent Knowledge of Correct Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: Immediate follow up (3 months)
Adolescent Attendance at Sexual and Reproductive Health Services
Time frame: Immediate follow up (3 months)
Adolescent HIV Testing Results
Time frame: Immediate follow up (3 months)
Adolescent Gonorrhea Testing Results
Time frame: Immediate follow up (3 months)
Adolescent Chlamydia Testing Results
Time frame: Immediate follow up (3 months)
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRRM Intervention in people with Behavior and Behavior Mechanisms, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unprotected Sex Acts Among Adolescent Males (time frame: Delayed follow up (9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.