Back to resultsA Regional Partnership to Improve Outcomes Through Fatherhood Engagement
Primary Purpose
Substance Use, Child Abuse, Child Neglect
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement
HERO Dads Fatherhood Program
Contingency Management
Case Management
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use
Eligibility Criteria
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
Sites / Locations
- Montefiore Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Services as Usual
Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)
Arm Description
Randomly assigned to receive services as usual
Randomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05562557
First Posted
September 26, 2022
Last Updated
May 15, 2023
Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05562557
Brief Title
A Regional Partnership to Improve Outcomes Through Fatherhood Engagement
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Child Abuse, Child Neglect, Fathers, Father-Child Relations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Services as Usual
Arm Type
No Intervention
Arm Description
Randomly assigned to receive services as usual
Arm Title
Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7)
Arm Type
Experimental
Arm Description
Randomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management)
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement
Intervention Description
To encourage intrinsic motivation to engage in fatherhood activities
Intervention Type
Behavioral
Intervention Name(s)
HERO Dads Fatherhood Program
Intervention Description
Fatherhood engagement curriculum to increase awareness, knowledge, and skills for parenting and co-parenting
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
To reinforce healthy behaviors, including attendance at services
Intervention Type
Behavioral
Intervention Name(s)
Case Management
Intervention Description
Referrals to treatment, social services, and employment services
Primary Outcome Measure Information:
Title
Child well-being, as measured by: Child Behavior Checklist
Description
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.
Time Frame
Baseline
Title
Child well-being, as measured by: Child Behavior Checklist
Description
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.
Time Frame
Follow Up (6-months after Baseline)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
As this project is about fatherhood, only those who identify as fathers will be included.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Jose, PhD
Phone
718-401-5060
Email
ajose@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra de Marchena, LCSW
Phone
718-401-5060
Email
allongo@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Wetzler, PhD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra de Marchena, LCSW
Phone
718-401-5060
Email
allongo@montefiore.org
First Name & Middle Initial & Last Name & Degree
Anita Jose, PhD
Phone
7184015060
Email
ajose@montefiore.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plan. May be possible to provide individual data (de-identified) for secondary data analysis.
Learn more about this trial
A Regional Partnership to Improve Outcomes Through Fatherhood Engagement
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