HERO Dads Program for Responsible Fatherhood

(FIRE Trial)

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to support responsible fatherhood among low-income dads in the Bronx. The HERO Dads Program aims to enhance parenting and relationship skills, improve anger management, and promote economic stability through job support. Participants will attend workshops either in person or virtually via Zoom. Fathers without full custody of their children who meet specific income criteria may be well-suited for this trial. As an unphased study, this trial offers a unique opportunity for fathers to develop their skills and strengthen family relationships.

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 prior data suggests that the HERO Dads Program is safe?

Research has shown that the HERO Dads Program offers education and resources to help fathers. Participants can join either online through Zoom or in person. The program aims to enhance fathers' parenting and relationship skills and assist them in finding jobs.

Since this program does not involve medical treatment, safety concerns differ from those in a medical trial. The focus is on learning and support, which are generally safe activities. Participants in similar programs have not reported harmful effects. Instead, these programs aim to positively impact personal and family well-being.

This program does not include medication or medical procedures, so there are no typical medical side effects. Participants can expect to gain new skills and support in a safe environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HERO Dads Program because it offers unique delivery methods for responsible fatherhood training. Unlike traditional in-person workshops, the program provides flexibility by offering virtual sessions via Zoom, making it more accessible for fathers who may have scheduling or transportation challenges. Additionally, this program emphasizes a personalized approach, tailoring workshops to meet the specific needs of participants, which could lead to more effective outcomes in fostering responsible fatherhood. By exploring these innovative methods, researchers hope to find out how different delivery modes impact the effectiveness of fatherhood training.

What evidence suggests that the HERO Dads Program is effective for promoting responsible fatherhood?

Research has shown that the HERO Dads Program helps fathers become more involved and responsible parents. The program includes workshops that teach parenting and relationship skills, along with job support and financial advice. Early results suggest that participants feel more confident and strong, which helps them support their children better. By focusing on education and skill-building, the program aims to strengthen the bond between fathers and their kids. In this trial, participants will join either the virtual (Zoom) arm or the in-person arm, offering flexible ways to benefit. ^{1 2 3 5 6}

Who Is on the Research Team?

Scott Wetzler, PhD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05562557

Study Details | NCT05562557 | A Regional Partnership to ... Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05311592/supporting-responsible-fatherhood-program-fatherhood-fire

Supporting Responsible Fatherhood Program ... The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05311592

Supporting Responsible Fatherhood Program ... The HERO Dads Program is a 4-week series of workshops for non-custodial fathers that focuses on improving parenting, offering job support, and financial ...

4. withpower.com withpower.com/trial/phase-relations-family-3-2021-553e7

HERO Dads Program for Responsible Fatherhood · Info ... 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 ...

5. montefioreeinstein.org montefioreeinstein.org/patient-care/hero-dads

HERO Dads Program | Patient Care Conditions. Chromosome Disorders; Disorders Affecting Muscles; Disorders Affecting the Kidneys & Reproductive Organs; Disorders Involving Imprinted Genes

6. acf.gov acf.gov/sites/default/files/documents/opre/learning-cycles-strengthen-fatherhood-programs-mar-2022.pdf

Using Learning Cycles to Strengthen Fatherhood Programs Federally funded Responsible Fatherhood programs work with fathers to promote healthy relationships and marriages, strengthen parenting practices, and help ...