HERO Dads Program for Responsible Fatherhood

(FIRE Trial)

Overseen By Traci Maynigo, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Intimate partner violence

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1475 Participants Needed

Trial Summary

What is the purpose of this trial?

Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope program to promote responsible fatherhood in the Bronx among low-income adult (18 years or older) fathers with non-custodial children (under the age of 24). The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and anger-management skills and providing marriage education; providing skills-based parenting education, disseminating information about good parenting practices, and encouraging child support payments (in partnership with our local OCSE); and fostering economic stability by providing employment-related supports inclusive of job search, vocational skills training, job referrals, and job retention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the HERO Dads Program treatment?

Research shows that programs like 'Healthy Dads, Healthy Kids' help fathers become positive role models and improve their health and family relationships. Engaging fathers in such programs can lead to better health outcomes for both fathers and their children. ^{1 2 3 4 5}

Is the HERO Dads Program for Responsible Fatherhood safe for participants?

There is no specific safety data available for the HERO Dads Program, but similar programs like 'Healthy Dads, Healthy Kids' have been successfully implemented with high attendance and satisfaction, suggesting they are generally safe for participants. ^{1 2 6 7 8}

How does the HERO Dads Program treatment differ from other treatments for responsible fatherhood?

The HERO Dads Program is unique because it focuses on empowering fathers through education and support to become healthy, resilient, and open, rather than using medical or pharmacological interventions. This approach is novel as it emphasizes personal development and responsible parenting skills, which are not typically addressed by standard medical treatments. ^{9 10 11 12 13}

Research Team

Scott Wetzler, PhD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

The Fatherhood FIRE program is for low-income fathers over 18 in the Bronx who don't live with their children but have kids under 24. It's aimed at dads wanting to improve parenting, support their kids financially, and stabilize their employment situation.

Inclusion Criteria

Income below 200% poverty line

Must be a non-custodial parent or have shared custody

I am over 18 years old.

Exclusion Criteria

Active intimate partner violence and increased risk of intimate partner violence.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the HERO Dads program, which includes relationship and parenting skills workshops, employment workshops, and individualized vocational case management.

4 weeks

All workshops completed virtually or in-person

Follow-up

Participants are monitored for changes in skills and knowledge, relationship satisfaction, and parenting outcomes.

6 months

Treatment Details

Interventions

• HERO Dads Program

Trial Overview The HERO Dads Program is being tested to see if it helps fathers enhance relationship skills, manage anger better, educate them on good parenting practices, ensure child support payments are made, and assist with job-related skills and opportunities.

Participant Groups

Group I: Virtual (Zoom) Experimental Treatment 1 Intervention

Participants will complete their intake process in person, but will complete all workshops virtually through Zoom.

Group II: In Person Experimental Treatment 1 Intervention

Participants will receive all services in person, including participating in the initial intake process, and attending all workshops.

HERO Dads Program is already approved in United States for the following indications:

Approved in United States as HERO Dads for:

• Not applicable; this is a social program, not a medical treatment.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

BronxWorks

Collaborator

Children's Bureau - Administration for Children and Families

Collaborator

Trials

23

Recruited

40,900+

Findings from Research

The 'Healthy Dads, Healthy Kids' (HDHK) program led to significant weight loss in fathers, with an average loss of 3.3 kg compared to a negligible change in the control group, indicating its effectiveness in promoting weight management.

The program also positively impacted various health metrics for fathers, including reductions in waist circumference, BMI, resting heart rate, and improvements in physical activity levels, while also encouraging increased physical activity in their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Morgan, PJ., Collins, CE., Plotnikoff, RC., et al.[2022]

The 'Healthy Dads, Healthy Kids' program led to significant weight loss in fathers, with an average loss of 7.6 kg over 6 months, compared to no weight change in the control group, indicating its efficacy in promoting weight management.

The program also improved various health metrics in fathers, such as waist circumference, BMI, blood pressure, and physical activity, while positively influencing children's physical activity and dietary habits, highlighting the program's role in fostering healthier family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children. Morgan, PJ., Lubans, DR., Callister, R., et al.[2022]

Paternal involvement in children's lives is linked to better outcomes such as improved cognition, mental health, and lower rates of obesity and asthma, highlighting the importance of engaging fathers in pediatric care.

Despite the benefits, pediatric care often focuses on mothers, neglecting paternal health, which could be improved by innovative strategies like motivational interviewing and mobile technologies to better involve fathers in their children's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Father Involvement for Child and Family Health. Allport, BS., Johnson, S., Aqil, A., et al.[2019]

In a study of 230 divorced fathers over 18 months, one third were clinically depressed, but overall, there were reductions in depression, smoking, and marijuana use, indicating potential improvements in mental health and substance use.

Fathering identity and involvement were linked to better health outcomes, as increased father involvement was associated with reduced drinking and marijuana use, highlighting the importance of supportive fathering in promoting healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and predictors of growth in divorced fathers' health status and substance use. DeGarmo, DS., Reid, JB., Leve, LD., et al.[2021]

The Male Involvement Network (MIN) model effectively engages low-income, ethnically diverse, non-custodial fathers by addressing their various health needs and promoting their roles as positive role models for their children.

This model emphasizes a relational approach that includes skill development in areas such as education, economic stability, and mental health, suggesting a comprehensive strategy for improving father-child relationships and overall family well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Outreach, Connection, and Services to Low-Income Non-Custodial Fathers: How Did We Get Here and What Do We Know. Gordon, DM., Hunter, B., Woods, LN., et al.[2021]

The Healthy Dads Healthy Kids (HDHK) program successfully reduced fathers' weight by an average of 3.6 kg, with this weight loss maintained over 12 months, demonstrating its efficacy in promoting healthier lifestyles among overweight fathers.

Improvements were also observed in children's BMI z-scores and lifestyle behaviors, indicating that the program positively impacted both fathers and their children, especially in low socioeconomic communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial. Morgan, PJ., Collins, CE., Lubans, DR., et al.[2020]

The Healthy Marriage and Responsible Fatherhood initiative has successfully provided relationship education and fatherhood programs to over 2 million individuals in the U.S. over the past two decades.

Recent randomized controlled trials conducted as part of this initiative aim to evaluate the effectiveness of these community-based programs, highlighting the integration of program evaluation with family science.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to special section: Federally funded, community-based healthy marriage and responsible fatherhood program impact studies. Rhoades, GK., Doss, BD., Carlson, RG.[2022]

The SAFE® program significantly improved secure attachment between infants and their fathers, with 84.6% of infants in the SAFE group securely attached compared to 65.8% in the control group, based on a year-long randomized control trial.

While the program effectively enhanced father-infant attachment, it did not show a significant difference in secure attachment between mothers and infants, indicating a targeted impact on father involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. Walter, I., Landers, S., Quehenberger, J., et al.[2020]

Ethanol is identified as a gonadal toxin that directly affects the testes and indirectly impacts the hypothalamus and pituitary, leading to issues like impotence and testicular atrophy in chronic alcoholics.

Some chronic alcoholics may recover normal sexual function after prolonged abstinence if they have not experienced testicular atrophy and respond normally to hormonal stimulation, while those with significant testicular damage may need medical interventions like penile prostheses or androgen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol: its adverse effects upon the hypothalamic-pituitary-gonadal axis. Van Thiel, DH.[2018]

Ethanol is confirmed as a gonadal toxin that directly affects male reproductive health, leading to issues like impotence and testicular atrophy due to both direct exposure and its metabolic byproducts.

Prolonged alcohol abstinence can lead to recovery of sexual function in some men, particularly if testicular atrophy hasn't occurred, but those with significant damage may require medical interventions like penile prostheses or hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol: its adverse effects upon the hypothalamic-pituitary-gonadal axis. Gavaler, JS., Urso, T., Van Thiel, DH.[2013]

Long-term ethanol consumption in male rats led to significant changes in the epididymis, including cell proliferation, fibrosis, and increased oxidative stress markers, indicating potential damage to reproductive health.

Ethanol exposure altered the expression of β-defensin isoforms in the epididymis, which may contribute to sperm abnormalities and impaired fertility, highlighting the complex effects of alcohol on male reproductive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term ethanol consumption promotes changes in β-defensin isoform gene expression and induces structural changes and oxidative DNA damage to the epididymis of rats. Sadeghzadeh, M., Shirpoor, A., Naderi, R., et al.[2020]

This study identified that 23 beta-defensin genes in the mouse epididymis are regulated by androgens, with six genes showing full androgen regulation, which is crucial for understanding sperm maturation and fertility.

The research highlights that certain beta-defensins are directly regulated by androgen receptors, suggesting potential targets for contraception and infertility treatments, while some genes are regulated independently of androgens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgenic regulation of beta-defensins in the mouse epididymis. Hu, SG., Zou, M., Yao, GX., et al.[2022]

The study examined steroid hormone production in immature testis tissues from two boys with ambiguous genitalia and one boy with precocious puberty, revealing that immature testes have active 17 beta-hydroxysteroid oxidoreductase, which is important for converting androstenedione into testosterone.

The findings suggest that while certain steroidogenic enzymes are limited in immature testes, the presence of active 17 alpha-hydroxylase and C17-20 lyase, especially in the boy with precocious puberty, indicates that testicular function may develop further during puberty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro steroidogenesis in testes of three infants, two with ambiguous external genitalia and one with true precocious puberty: Evidence for the presence of active 17 beta-hydroxysteroid oxidoreductase in immature human testes. Oshima, H., Ishiwata, D., Hatakeyama, S., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting Father Involvement for Child and Family Health. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Patterns and predictors of growth in divorced fathers' health status and substance use. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Increasing Outreach, Connection, and Services to Low-Income Non-Custodial Fathers: How Did We Get Here and What Do We Know. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Twelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Introduction to special section: Federally funded, community-based healthy marriage and responsible fatherhood program impact studies. [2022]

8. England pubmed.ncbi.nlm.nih.gov

*The efficacy of the attachment-based SAFE® prevention program: a randomized control trial including mothers and fathers. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Ethanol: its adverse effects upon the hypothalamic-pituitary-gonadal axis. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Ethanol: its adverse effects upon the hypothalamic-pituitary-gonadal axis. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Long-term ethanol consumption promotes changes in β-defensin isoform gene expression and induces structural changes and oxidative DNA damage to the epididymis of rats. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Androgenic regulation of beta-defensins in the mouse epididymis. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

In vitro steroidogenesis in testes of three infants, two with ambiguous external genitalia and one with true precocious puberty: Evidence for the presence of active 17 beta-hydroxysteroid oxidoreductase in immature human testes. [2019]