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 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.

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
    • The 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:

• 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 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; Evidence-based adaptation of Motivational Interviewing (MI), designed to target ambivalence to change and create internal motivation to engage in substance abuse treatment; Behavioral: 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.; Behavioral: Contingency Management; To improve attendance at services and abstinence outcomes.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Father engagement based on the Child-Parent Relationship Scale, Short form (CPRS-SF)	Father engagement will be measured by the Child-Parent Relationship Scale, Short form (CPRS-SF). The CPRS-SF is a 15-item self-report measure assessing the current relationship between parent and child. Items are rated on a 5-point Likert scale ranging from 1 ("definitely does not apply") to 5 ("definitively applies"). Ratings are averaged into groups of items corresponding to conflict items (8 items) and closeness (7 items) subscales for this study. Higher scores indicate higher levels of the specific construct (i.e., more conflict or more closeness). Higher conflict score reflects higher negativity; higher closeness score reflects warmth, affection, and open communication.	Baseline and 6 Month followup
Father engagement based on the Inventory of Father Involvement, Short form (IFI-SF)	Father engagement will also be measured by the Inventory of Father Involvement, Short Form (IFI-SF). The IFI-SF is a 26-item measure of father involvement, focusing on the following subscales: discipline and teaching responsibility, school encouragement, providing, time and talking together, praise and affection, developing talents, reading/homework, supporting the coparent, and attentiveness. Items are rated using a 7-point Likert scale ranging from 0 ("Very Poor") to 6 ("Excellent"). For this study, scores are averaged, yielding a score of 0-6 overall. Higher scores indicate higher levels of perceived father involvement.	Baseline and 6 Month followup
Father engagement based on the Parenting Alliance Inventory (PAI)	Father engagement will also be measured by the Parenting Alliance Inventory (PAI). The PAI is a 20-item scale that assesses the co-parenting relationship between parents. Items are rated using a 5-point Likert scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"); for this study, scores are averaged for a range of 1-5. Higher scores indicate a stronger, more positive, and cooperative partnership.	Baseline and 6 Month followup
Father behavioral health based on the Addiction Severity Index (ASI, adapted)	Father behavioral health will be measured by the Addiction Severity Index (ASI, adapted). The ASI is a self-report measure addressing potential problems associated with substance use. This study will use only the drug and alcohol section. The drug and alcohol section of the ASI consists of a severity assessment where the participant is asked to rate the severity of their drug and alcohol addiction, over the past 30 days, using a numeric computation with many components. This measure summarizes the patient's need for treatment. Results for each component will be summarized by study arm.	Baseline and 6 Month followup
Father behavioral health based on the Center for Epidemiological Studies Depression Scale (CESD, adapted)	Father behavioral health will also be measured by the Center for Epidemiological Studies Depression Scale (CESD, adapted). This study uses a 12-item short form of this self-report scale is designed to measure depressive symptomatology in adult populations. Items are rated using a 4-point Likert scale ranging from 0 ("Rarely or none of the time (i.e., <1 day)") to 3 ("Most or all of the time (i.e., 5-7 days)"), yielding an overall possible score of 0-36 for this adaptation. Higher scores indicate more clinically significant depressive symptoms.	Baseline and 6 Month followup
Father behavioral health based on the Trauma Symptom Checklist-40 (TSC-40)	Father behavioral health will also be measured by the Trauma Symptom Checklist-40 (TSC-40). The TSC-40 evaluates symptomatology in adults associated with childhood or adult traumatic experiences. It measures aspects of posttraumatic stress and other symptom clusters found in some traumatized individuals. In this study, the parent will respond based on their own behavioral symptoms. The TSC-40 consists of 40 items across six domains (anxiety, depression, dissociation, sexual abuse trauma index, sexual problems, and sleep disturbance) wherein parents self-report trauma-related symptoms on a 4-point frequency scale ranging from 0 ("Never") to 3 ("Often"), yielding a total score of 0-120, such that higher scores are indicative of higher distress.	Baseline and 6 Month followup

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine; Children's Bureau - Administration for Children and Families; Mathematica Policy Research, Inc.; New York State Office of Addiction Services and Supports; New York State Office of Children and Family Services; New York City Human Resources Administration (HRA); New York City Administration for Children's Services
• 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 1, 2027
• Study Completion (Estimated): September 1, 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): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Health Services Administration; Patient Care Management; Patient Care Planning; Comprehensive Health Care; Case Management
• Other Study ID Numbers: 2022-14401; 90-CU-0116 (Other Grant/Funding Number: Children's Bureau - Administration for Children and Families)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• 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