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NCT Number: NCT05562557

A Regional Partnership to Improve Outcomes 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Contingency Management

Behavioral

To improve attendance at services and abstinence outcomes.

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.

Primary outcomes

  1. Child well-being

    Time frame: Baseline and 6 Month followup

    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.

Secondary outcomes

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

    Time frame: Baseline and 6 Month followup

    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.

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

    Time frame: Baseline and 6 Month followup

    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.

  3. Father engagement based on the Parenting Alliance Inventory (PAI)

    Time frame: Baseline and 6 Month followup

    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.

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

    Time frame: Baseline and 6 Month followup

    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.

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

    Time frame: Baseline and 6 Month followup

    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.

  6. Father behavioral health based on the Trauma Symptom Checklist-40 (TSC-40)

    Time frame: Baseline and 6 Month followup

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra de Marchena, LCSW

CONTACT

[email protected]

718-401-5060

Anita Jose, PhD

CONTACT

[email protected]

718-401-5060

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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