- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05256992
TYRO Champion Dads Project Study
Impact Evaluation of the TYRO Champion Dads Project in Dallas, Texas
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75254
- Anthem Strong Families
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment-Enhanced Services (Standard + Ray of Hope)
Treatment group participants receive standard and enhanced services.
Standard services are delivered as primary services to participants in both study groups under a shared condition, and they are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula.
Finally, only the treatment group receives 10 hours of the Ray of Hope curriculum as an enhanced service.
Optional services are available to both study groups by selecting 1-3 hours of coursework from a menu of courses in the Mini-Clinic that address a variety of needs.
|
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 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.
|
|
Experimental: Control-Standard Services
Only standard services are delivered to participants in the control group under a shared condition with the treatment group, and they are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula.
Optional services are available to both study groups by selecting 1-3 hours of coursework from a menu of courses that address a variety of needs.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome Measures 1: Healthy Parenting Behavior
Time Frame: change from baseline to 6-months after enrollment
|
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?
The 11 items are measured as a construct. All items are added together and divided by 11 to create the construct score. maximum score of 5.0, minimum score of 1.0 |
change from baseline to 6-months after enrollment
|
|
Primary Outcome Measures 2: Healthy Parenting Behavior
Time Frame: baseline to 6-months after enrollment
|
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 maximum score of 5.0, minimum score of 1.0 |
baseline to 6-months after enrollment
|
|
Primary Outcome Measure 3: Healthy Co-parenting Behavior
Time Frame: change from baseline to 6-months after enrollment
|
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'). The 11 items are measured as a construct. All items are added together and divided by 11 to create the construct score. The higher the score, the better the outcome. maximum score of 5.0, minimum score of 1.0 |
change from baseline to 6-months after enrollment
|
|
Primary Outcome Measures 4: Healthy Partner Relationship Behavior
Time Frame: change from baseline to 6-months after enrollment
|
• Average of 8 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 and show a better outcome. The 8 items are measured as a construct. All items are added together and divided by 8 to create the construct score. maximum score of 5.0, minimum score of 1.0 |
change from baseline to 6-months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome Measure 1: Healthy Parenting Attitudes
Time Frame: baseline to 6-months after enrollment
|
What is the impact of enhanced TCD services (treatment) compared to standard TCD services only (control) on healthy parenting attitudes 6-months after TCD enrollment? • 7 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'). The 7 items are measured as a construct. All items are added together and divided by 7 to create the construct score. The lower the score, the better the outcome. maximum score of 5.0, minimum score of 1.0 |
baseline to 6-months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matt D Shepherd, PhD, Midwest Evaluation & Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- #2021/03/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fathers
-
Midwest Evaluation & ResearchFresno Area Workforce Development Board (FAWDB)Completed
-
Midwest Evaluation & ResearchAction for ChildrenCompleted
-
University of Texas at AustinTerminated
-
Midwest Evaluation & ResearchAnthem Strong FamiliesCompleted
-
McMaster UniversityActive, not recruitingPerinatal Depression | FathersCanada
-
Midwest Evaluation & ResearchFathers IncorporatedCompletedFathersUnited States
-
Midwest Evaluation & ResearchGoodwill of Central TexasCompleted
-
Midwest Evaluation & ResearchSeedco: Strong Fathers, Stronger FamiliesCompleted
-
Midwest Evaluation & ResearchSocial Advocates for Youth (SAY) San Diego Dads CorpsCompleted
-
California State University, San MarcosUS Department of Health and Human ServicesCompleted
Clinical Trials on Standard Servies + Ray of Hope Curriculum
-
University of ArkansasPatient-Centered Outcomes Research InstituteRecruitingPregnancy Complications | Diet, Healthy | Gestational Diabetes | Gestational Weight Gain | Gestational HypertensionUnited States
-
Duke UniversityNational Institute of Mental Health (NIMH); Kilimanjaro Christian Medical Centre...CompletedHIV Infections | Quality of Life | Suicidal Ideation | Suicide | Adherence, Medication | Treatment Adherence and Compliance | Stigma, Social | DisclosureTanzania
-
Washington University School of MedicineTerminated
-
University Hospitals Coventry and Warwickshire...Completed
-
Stanford UniversitySiemens Healthcare Diagnostics IncCompletedCarcinoma, HepatocellularUnited States
-
Dana-Farber Cancer InstituteNational Institute of Nursing Research (NINR)Completed
-
Damanhour UniversityCompletedNeurosurgery | Neurologic ComplicationEgypt
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | LeukemiaUnited States
-
Mayo ClinicRecruitingIndolent Non-hodgkin Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaUnited States
-
Liverpool School of Tropical MedicineCentre for Control of Chronic Disease (CCCD),icddr,b; Comité National d'Ethique... and other collaboratorsNot yet recruitingTB - Tuberculosis