NCT05285267

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

March 9, 2022

Last Update Submit

September 4, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (3)

Parent-Child Activities

ACTIVE COMPARATOR

Families assigned to the active control group will participate in weekly "parent-child open house" where the parents will be permitted to meet with other parents in the meeting room and the children will be invited to attend an open gym. There will be no formal curriculum for the parent meetings, but the facilitator will be available to inform the parents of community resources (e.g., mentorship programs) and a resources table will be made available of community activities and referrals in the same manner as the other two groups.

Behavioral: Shared Parent-Child Activities

Nurturing Fathers

EXPERIMENTAL

The Nurturing Fathers program (Perlman, 2021) is an adaptation of the Nurturing Parent program. It is a 13-week program that covers the role of fathers, the importance of nurturance rather than fear in fathering, how to effectively play and discipline a child, how to build relationships with the child and co-parent, and it ends with a graduate ceremony. For the present study, consistent with a prevention approach, the investigators will modify the Nurturing Fathers program to focus on the content directly related to parenting skills. The investigators will implement an eight-week program, which is consistent with the duration of prior, successfully attended father-focused interventions (e.g., Fabiano et al., 2009).

Behavioral: Behavioral Parent Support

Nurturing Fathers + COACHES

EXPERIMENTAL

The Nurturing Fathers program described above will be implemented as described. For the last 45 minutes of the sessions, fathers will join the child activity group and participate in shared parent-child activities consistent with the COACHES model. For the present study, several adaptations to the clinic-based COACHES program will be made, similar to those successfully deployed in our preliminary study in Head Start preschool settings (Caserta, Fabiano, et al., 2018). The investigators will use the Nurturing Fathers curriculum as the substantive content for each meeting, and then use the parent-child interactions within recreational sports as the forum for practicing skills.

Behavioral: Behavioral Parent SupportBehavioral: COACHES

Interventions

Parent training on effective child management strategies

Nurturing FathersNurturing Fathers + COACHES

Structured parent-child activities

Parent-Child Activities
COACHESBEHAVIORAL

This intervention involves practice of parenting strategies with facilitator monitoring and support.

Nurturing Fathers + COACHES

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Children and Families

Amherst, New York, 14226, United States

Location

MeSH Terms

Interventions

Doulas

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Parent-child observations will be conducted by a masked observer.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

March 1, 2022

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations