A Regional Partnership to Improve Outcomes Through Fatherhood Engagement

NCT05562557 | Recruiting DMC

• 2 other identifiers: 2022-1440190-CU-0116
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Child well-being

  Child well-being will be assessed by the Child Behavior Checklist. This is a standardized self-report measure widely used in the measure of child behavior and child well-being. Separate forms are used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.

  Baseline and 6 Month followup

Secondary Outcomes (6)

• Father engagement based on the Child-Parent Relationship Scale, Short form (CPRS-SF)

  Baseline and 6 Month followup

• Father engagement based on the Inventory of Father Involvement, Short form (IFI-SF)

  Baseline and 6 Month followup

• Father engagement based on the Parenting Alliance Inventory (PAI)

  Baseline and 6 Month followup

• Father behavioral health based on the Addiction Severity Index (ASI, adapted)

  Baseline and 6 Month followup

• Father behavioral health based on the Center for Epidemiological Studies Depression Scale (CESD, adapted)

  Baseline and 6 Month followup

Study Arms (2)

Services as Usual

NO INTERVENTION

Randomly assigned to receive services as usual

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

EXPERIMENTAL

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

Behavioral: Motivational Enhancement; Behavioral: HERO Dads Fatherhood Program; Behavioral: Contingency Management; Behavioral: Case Management

Interventions

Motivational Enhancement BEHAVIORAL

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

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

HERO Dads Fatherhood Program BEHAVIORAL

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.

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

Contingency Management BEHAVIORAL

To improve attendance at services and abstinence outcomes.

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

Case Management BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As this project is about fatherhood, only those who identify as fathers will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Albert Einstein College of Medicine: collaborator
• Mathematica Policy Research, Inc.: collaborator
• New York State Office of Children and Family Services: collaborator
• New York State Office of Addiction Services and Supports: collaborator
• New York City Human Resources Administration (HRA): collaborator
• Children's Bureau - Administration for Children and Families: collaborator
• New York City Administration for Children's Services: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Scott Wetzler, PhD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Jose, PhD

CONTACT

718-401-5060; ajose@montefiore.org

Alessandra de Marchena, LCSW

CONTACT

718-401-5060; allongo@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 2:1 treatment:comparison randomization scheme is planned. Statistical Analysis System (SAS) will be used to generate the scheme and block randomization will be used to ensure the ratio. Randomization will not be stratified. The rationale for this is that it is believed participant characteristics would be similar across different enrollment resources (i.e., different enrollment sites). The evaluator and statistician, who do not have access to the participants or their records, will be generate the randomization scheme.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: May 9, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)