Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT05562557

Conditions

Substance Use

Child Abuse

Child Neglect

Fathers

Father-Child Relations

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Motivational Enhancement

HERO Dads Fatherhood Program

Contingency Management

Case Management

Study Details

Brief summary:

Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.

Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.

Conditions

Substance Use

Child Abuse

Child Neglect

Fathers

Father-Child Relations

Study ID

NCT05562557

Start date

May 9, 2023

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • is a custodial or non-custodial father
  • speaks English or Spanish
  • has at least one child under the age of 18,
  • someone in the family is identified as at-risk for substance use through: self-report of illicit substance use in the family, the presence of an SUD diagnosis in the family, a clinician/provider identified substance use risk, or the presence of a substance-related indicated child welfare allegation in the family

Exclusion Criteria:

  • The placement of all children in the family in foster care

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Services as Usual

Randomly assigned to receive services as usual

experimental: Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)

Randomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management)

Interventions

Motivational Enhancement

Evidence-based adaptation of Motivational Interviewing (MI), designed to target ambivalence to change and create internal motivation to engage in substance abuse treatment

HERO Dads Fatherhood Program

Use the 24/7 Dad fatherhood curriculum, delivered by Montefiore HERO Dads, with an additional 4-session employment education curriculum and 3-session parent coaching to reinforce individual skills learned in fatherhood curriculum. Curriculum designed to increase awareness, knowledge, and skills for parenting and co-parenting.

Contingency Management

To improve attendance at services and abstinence outcomes.

Case Management

Referrals to substance use disorder (SUD) treatment and engagement, mental health resources, public assistance resources, connection to the Office of Childhood Services and other case management needs.

Primary outcome measure

  • Child well-being [ Time Frame: Baseline and 6 Month followup ]

Central Contacts and Locations

Central contacts

Anita Jose, PhD

718-401-5060ajose@montefiore.org

Alessandra de Marchena, LCSW

718-401-5060allongo@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Alessandra de Marchena, LCSW

718-401-5060allongo@montefiore.org

Anita Jose, PhD

7184015060ajose@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-03-24.