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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05562557
Other study ID # 2022-14401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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