A Regional Partnership to Improve Outcomes Through Fatherhood Engagement

Substance Use Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562557
• Other study ID #: 2022-14401
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: Anita Jose, PhD
• Phone: 718-401-5060
• Email: ajose[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Child Neglect
• Father-Child Relations
• Fathers
• Substance Use
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)