Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05256992
Other study ID # #2021/03/35
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date August 15, 2025

Study information

Verified date April 2024
Source Midwest Evaluation & Research
Contact McKenna C LeClear, MA
Phone 833-643-9377
Email mckenna.leclear@midwestevaluation.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This impact evaluation aims to determine if the addition of 10 hours of domestic violence prevention programming is effective at improving outcomes among those program participants who are randomly assigned to the treatment group. Both study groups will receive standard TYRO Champion Dads services (the TYRO Dads and TYRO Core Communication evidence-based curricula, plus support services), but only the treatment group will be offered the additional Ray of Hope curriculum hours focused on mitigating risk factors related to domestic violence.


Description:

Anthem Strong Families (ASF) is reviewing the Ray of Hope curriculum as a possible addition to standard TCD services to better meet the needs of populations that may have unmet needs to address domestic violence in their families. The Ray of Hope curriculum is designed to help participants develop communication and conflict management skills like Core Communication but is a more robust approach since it adds a sharp focus on the dynamics of domestic violence and related risk factors. The impact of the addition of the Ray of Hope curriculum will be assessed by comparing outcomes for participants who receive standard TYRO Champion Dads (TCD) services, which includes the TYRO curriculum plus support services, and participants who receive both standard services plus 10 Ray of Hope curriculum hours. Goal 1: determine if treatment group participants who receive enhanced TCD services report healthier parenting attitudes compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 2: determine if treatment group participants who receive enhanced TCD services report healthier partner relationship behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 3: determine if treatment group participants who receive enhanced TCD services report healthier parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 4: determine if treatment group participants who receive enhanced TCD services report healthier co-parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.


Recruitment information / eligibility

Status Recruiting
Enrollment 683
Est. completion date August 15, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (age 18 and older) - Father (children must be no more than 24 years of age) - must have no open criminal cases (can be deferred) Exclusion Criteria: - Minor (under the age of 18) - Not a father - Has an open criminal case

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard Servies + Ray of Hope Curriculum
Standard services delivered as primary services to participants in both study groups under a shared condition are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. Optional services available to both study groups by selecting 1-3 hours of coursework from menu of courses that address a variety of needs.
Standard Services
Standard services delivered as primary services to participants in both study groups under a shared condition are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula.

Locations

Country Name City State
United States Anthem Strong Families Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
Midwest Evaluation & Research Anthem Strong Families

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measures 1: healthy parenting behavior What is the impact of enhanced TCD services (treatment) compared to standard TCD services only (control) on healthy parent behavior 6 months after TCD enrollment?
• Average of 10 to 11 survey items (depending on child age) that relate to frequency of positive interactions with participant's youngest child using categories on a five-point scale where 1 is never and 5 is every day or almost every day
o Higher scores are always positive
change from baseline to 6-months after enrollment
Primary Primary Outcome Measures 2: healthy parenting behavior What is the impact of enhanced TCD services (treatment) compared to standard TCD services only (control) on healthy parent behavior 6 months after TCD enrollment?
• 1 survey item measures the reported frequency of fighting with their child on a five point scale where 1 is never and 5 is every day or almost every day
o A lower score is better
change from baseline to 6-months after enrollment
Primary Primary Outcome Measure 3: healthy co-parenting behavior What is the impact of enhanced TCD services (treatment) compared to standard TCD services only (control) on healthy co-parent behavior 6 months after TCD enrollment?
11 survey items measure the reported frequency of agreement with key co-parenting behaviors using categories on a 5-point scale (1 'Strongly Disagree', 2 'Disagree', 3 'Neither Agree Nor Disagree', 4 'Agree', 5 'Strongly Agree').
Higher scores on 5 items are positive (ex. - The mother of my youngest child and I make joint decisions about our youngest child.)
Higher scores on 6 items are negative (ex. - The mother of my youngest child undermines me as a father.) and will be reverse coded so that a higher score will be positive
change from baseline to 6-months after enrollment
Primary Primary Outcome Measures 4: healthy partner relationship behavior • Average of 7 survey items related to frequency of disagreement with partner on different topics using categories on a 5-point scale where 1 is never and 5 is always Lower scores are positive
1 survey item measuring reported frequency of fighting with romantic partner using categories on a 5 point scale where 1 is never and 5 is always Lower scores are positive
change from baseline to 6-months after enrollment
Secondary Secondary Outcome Measure 1: healthy parenting attitudes What is the impact of enhanced TCD services (treatment) compared to standard TCD services only (control) on healthy parenting attitudes 1 year after TCD enrollment?
• 6 survey items measure the reported frequency of healthy parenting attitudes using categories on a 5-point scale (1 'Always', 2 'Often', 3 'Rarely', 4 'Sometimes', 5 'Never').
Higher scores on 4 items are positive (ex. - How often do you feel disappointed with your youngest child?)
Higher scores on 3 items are negative (ex. - How often do you feel proud of your youngest child?)
change from baseline to 6-months after enrollment
See also
  Status Clinical Trial Phase
Terminated NCT01395238 - Enhancing Father's Ability to Support Their Preschool Child N/A
Terminated NCT04591730 - First-time Fathers' Experiences of Childbirth in Lorraine
Recruiting NCT05562557 - A Regional Partnership to Improve Outcomes Through Fatherhood Engagement N/A
Completed NCT05535348 - Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs N/A
Completed NCT01851577 - Engaging Fathers in Home Visitation N/A
Completed NCT04727125 - Evaluating the Effects of Kangaroo Care in the NICU
Enrolling by invitation NCT05097833 - Local Evaluation of the Saint Francis Ministries Fatherhood FIRE Program N/A
Completed NCT04990622 - The Effect of Diet on Parents' Mental Health in the Postnatal Period N/A
Completed NCT04971460 - The Mental Well-being of Fathers and Partners
Not yet recruiting NCT06289101 - text4FATHER R21: Social Media - Efficacy Trial N/A
Completed NCT02201433 - Study on the Treatment of Children and Their Families in Services Related to Early Childhood
Completed NCT04322058 - Pathways to Fatherhood and Families: The Dads' Club
Not yet recruiting NCT05250258 - Telephone Peer Support to Prevent Depression Among Fathers
Completed NCT05588089 - The Effect of Baby Care Training Given to Fathers After Birth N/A
Recruiting NCT06320587 - The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs N/A
Active, not recruiting NCT04101565 - Text4Father Pilot Feasibility, Acceptability Study N/A
Completed NCT04611542 - Fathering In Recovery N/A
Terminated NCT02855996 - Evaluation of AVANCE Fathers in Action/Padres Activos Fatherhood Program N/A
Recruiting NCT05239754 - Fresno FAWDB FIRE Program Evaluation N/A
Recruiting NCT05298345 - Family Champions Project N/A