A Regional Partnership to Improve Outcomes Through Fatherhood Engagement

A Regional Partnership for New York City to Improve Well-Being and Child Welfare Outcomes Among Families at Risk of Substance Misuse Through Fatherhood Engagement

Montefiore will engage fathers in families at risk of substance misuse in the Bronx. Families will be referred from Bronx community-based 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.

Study Overview

• Status: Recruiting
• Conditions: Child Abuse; Substance Use; Child Neglect; Fathers; Father-Child Relations
• Intervention / Treatment: Behavioral: Motivational Enhancement; Behavioral: HERO Dads Fatherhood Program; Behavioral: Contingency Management; Behavioral: Case Management

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandra de Marchena, LCSW; Phone Number: 718-401-5060; Email: allongo@montefiore.org
• Study Contact Backup: Name: Anita Jose, PhD; Phone Number: 718-401-5060; Email: ajose@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Alessandra de Marchena, LCSW; Phone Number: 718-401-5060; Email: allongo@montefiore.org
      • Contact: Anita Jose, PhD; Phone Number: 7184015060; Email: ajose@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• (i) is a custodial or non-custodial father,
• (ii) who has at least one child under the age of 18,
• (iii) someone in the family is identified as at-risk for substance use

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Behavioral: Motivational Enhancement; To encourage intrinsic motivation to engage in fatherhood activities; Behavioral: HERO Dads Fatherhood Program; Fatherhood engagement curriculum to increase awareness, knowledge, and skills for parenting and co-parenting; Behavioral: Contingency Management; To reinforce healthy behaviors, including attendance at services; Behavioral: Case Management; Referrals to treatment, social services, and employment services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child well-being, as measured by: Child Behavior Checklist	This is a standardized self-report measure widely used in the measure of child behavior and child well-being. A separate form is 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
Child well-being, as measured by: Child Behavior Checklist	This is a standardized self-report measure widely used in the measure of child behavior and child well-being. A separate form is 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.	Follow Up (6-months after Baseline)

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Scott Wetzler, PhD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2022-14401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan. May be possible to provide individual data (de-identified) for secondary data analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No