A Regional Partnership to Improve Outcomes Through Fatherhood Engagement

Sponsor
Montefiore Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05562557
Collaborator
Albert Einstein College of Medicine (Other)
240
2
55

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Enhancement
  • Behavioral: HERO Dads Fatherhood Program
  • Behavioral: Contingency Management
  • Behavioral: Case Management
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Child well-being, as measured by: Child Behavior Checklist [Baseline]

    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.

  2. Child well-being, as measured by: Child Behavior Checklist [Follow Up (6-months after Baseline)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Montefiore Medical Center
  • Albert Einstein College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT05562557
Other Study ID Numbers:
  • 2022-14401
First Posted:
Sep 30, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2022