Engaging Male Caregivers in Effective Prevention Programming to Reduce Risk of Violence and Violence-Related Injury

Parenting Clinical Trial

Official title:

Engaging Male Caregivers in Effective Prevention Programming to Reduce Risk of Violence and Violence-Related Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285267
• Other study ID #: IRB-21-0474
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Florida International University
• Contact: Gregory A Fabiano, PhD
• Phone: 716-359-7823
• Email: gfabiano[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Importantly, the majority of child victims were those five and younger. Contrary to these potential negative impacts, fathers contribute positively to many aspects of child development and overall family functioning, making unique contributions to child peer relationships, language development, academic skills, and the proficiency of the other parent in parenting tasks. Thus, efforts to emphasize the father's role in the child's life, and attenuate any potential risks due to child or family directed violence, represent key public health initiatives within prevention efforts. There are many potential prevention programs that have been developed to support male caregivers. The Nurturing Fathers program and the Coaching Our Children: Heightening Essential Skills program are two examples of father-focused preventive intervention efforts. However, these approaches have not typically been evaluated as preventive interventions in community-based samples using scientifically rigorous methods. Thus, the present study aims to evaluate the effectiveness of these approaches in reducing family violence and improving male caregiver competencies in a randomized, controlled trial. Specifically, Nurturing Fathers Alone and Nurturing Fathers + COACHES will be compared to an attention control, and male caregivers and their children will be randomly assigned to one of the three groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Resident of Western New York
• Have a target child three to six years of age
• Have a male caregiver who consents to participate in the study
• Caregiver and child can speak and understand English.

Exclusion Criteria:

• A child with an estimated IQ less than 70
• Any child who is presenting with severe developmental delays (e.g., autism level 2 or 3)
• A child or caregiver who previously participated in the study
• Any target child who has a male or female caregiver who has had a previous, founded, child protection complaint (will be excluded from the study and referred to alternative programming)

Related Conditions & MeSH terms

• Child Maltreatment
• Parenting

Intervention

Behavioral:
• Behavioral Parent Support
Parent training on effective child management strategies
• Shared Parent-Child Activities
Structured parent-child activities
• COACHES
This intervention involves practice of parenting strategies with facilitator monitoring and support.

Locations

Country	Name	City	State
United States	Center for Children and Families	Amherst	New York

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Buffalo Prenatal Perinatal Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Observations of Parenting	The Dyadic Parent Child Interaction Coding scheme will be used to assess parent behaviors (negative Talk, Indirect and direct commands, labelled and unlabelled praise) and child behaviors (Negative talk, compliance, noncompliance)	Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
Primary	Conflict Tactics Scale	This is a measure of conflict resolution and tactics used between the male Completed by the caregiver and the child's other parent. Scores range from "This has never happened to More than 20 times in the past month. The scale measures frequency of behaviors from zero to more than 20 times. Higher scores indicate a worse outcome.	Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
Primary	Parenting Alliance Inventory	This is a measure of alignment in parenting practices. Answers range from strongly agree to strongly disagree on a five point scale. Scores range from 1-5, with lower scores indicating improvement.	Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)