FathersNCT05298345
Family Champions Project
A study testing Family Champions Project Primary Services in people with Fathers and Mothers, run by Midwest Evaluation & Research at 1 site in United States.
Trial summary
This evaluation uses a formative approach and a descriptive design with repeated measures to assess the efficacy of a Continuous Quality Improvement (CQI) Process to improve services delivered by the Family Champions Project (FCP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Family Champions Project Primary Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age 18 and older)
- Parent
- No open criminal cases (or deferred)
Who cannot join
- Minor (under the age of 18)
- Not a parent
- Has an open criminal case (or not deferred)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of the Family Champions Project
This evaluation uses a formative approach and a descriptive design with repeated measures to assess the efficacy of a Continuous Quality Improvement (CQI) Process to improve services delivered by the Family Champions Project (FCP). The FCP delivers education-based services-TYRO Leadership and Core Communication curricula-with funding from the Office of Family Assistance to low-income fathers and mothers to promote healthy family relationships and economic stability in their households. TYRO Leadership and Core Communication are adapted from the TYRO suite of curricula that were developed by the RIDGE Project, and they are designed to improve the relationships of families affected by the incarceration of a parent and the economic stability of their households. Participants must be at least 18 years of age with a child no older than 24 years and have no open criminal cases (cases can be deferred). Evaluation activities are carried out by Midwest Evaluation and Research (MER) and assess the extent to which our CQI Process is a feasible approach to improve outputs and the outcomes that might be associated with them for an education-based service delivery effort like the FCP.
Specifically, study results from formative evaluation will inform practitioners in the field of HMRE about the viability of using a CQI Process like ours to achieve full implementation and provide some evidence about its capacity to improve outcomes. Formative evaluation not only assesses experiences of the CQI Team and front-line service staff while implementing our CQI Process, but also pays attention to the timing and other specifics of any performance interventions that occur over the 5-year project. As a result, performance interventions present opportunities to conduct a series of mini studies to descriptively evaluate CQI Team efforts to improve implementation of the FCP. Performance trends that improve after an intervention indicate the CQI Team was likely successful to more fully implement outputs which should result in a positive effect on retention rates and, in turn, short term outcomes if we assume a sound theory of change for the FCP is depicted in the logic model.
Read the detailed description
Efforts to conduct CQI are in the early stages of development in the field of Healthy Marriage and Relationship Education (HMRE). The Office of Family Assistance (OFA) has required HMRE grantees to conduct CQI as part of project activities since funding began for them in 2006. However, HMRE grantees have likely not bought into the CQI Process given the absence of user-friendly conceptual frameworks to guide CQI efforts and empirical evidence to demonstrate they improve implementation of project activities and, in turn, enhance participant outcomes that might be attributed to them.
The CQI Process used in this study was developed by Dr. Theodore C. Jurkiewicz and then enhanced after starting work at MER, and it begins by forming a CQI-Team. The CQI-Team is a collaboration between practitioners with the authority to make implementation decisions about the FCP and evaluators at MER who handle data analyses and reporting.
The CQI Team carries out a multistep plan that is repeated each program year to fully implement FCP educational services over time by using a series of indicators to track performance trends for various outputs from a different perspective in each step. Percentage of target enrollment, percentage of target population that reflect eligibility characteristics, hours of dosage received by participants, response rates to participant surveys that measure outcomes among other indicators and outputs are tracked for monthly and quarterly enrollment cohorts in each program year and presented in CQI Reports that take the perspective associated with each of the steps. The CQI Team discusses findings presented by evaluators for overall performance trends in bi-weekly reports for the 1st step and performance trends by site in quarterly reports presented twice per year for steps 2 and 3. Then, members of the CQI-Team collaborate with front line service staff to develop interventions for any performance trend with an output that seems likely to fall short of standards by the end of the program year. Effects of interventions on outputs are reported by site in step 4.
Ultimately, successful performance interventions designed and implemented by the CQI Team in collaboration with front-line service staff should improve the outputs associated with FCP services over time, and the most immediate impact should be evident in participant retention rates. Interventions that lead to higher enrollment and then improved attendance should lead to a higher incidence of complete program status (active, complete, not in program), which means FCP services are being delivered to more participants in larger doses. Larger doses of services delivered to participants after performance interventions which means the CQI Team is facilitating progress to meet performance standards because participants receive the amounts of FCP services intended for them.
What is more, higher retention rates over time should lead to improved short-term outcomes for participants. Participants who receive larger doses of FCP services after performance interventions should acquire more knowledge in educational sessions than those who receive smaller doses. However, rigorous measures of participant knowledge are not available because it was not possible to get full access to proprietary curricula to develop them. Consequently, participant attitudinal changes will be the only focus for measuring short-term outcomes in this study. Attitudes change more quickly in healthy and productive ways after merely exposing participants to new ways of thinking about parenting, handling finances, or accessing employment with curriculum content in the FCP.
Finally, FCP services cannot determine participant outcomes but only contribute to them amongst a host of other factors, which makes it difficult for a descriptive study to link behavioral change to CQI efforts. Healthier and more productive behaviors take time to emerge, develop, and hopefully replace old behaviors because they are subject to a host of other influences on FCP participants. What is more, low-income individuals in the FCP target population, especially those who are parents, experience changing life circumstances more often than those from wealthier households that make them more vulnerable to a host of risk-related factors, such as unstable employment, tenuous housing situations, or limited sources of support that are available from family and friends. Changing life circumstances for low-income individuals make it more difficult for FCP services to have a positive, lasting impact on their behavior.
In sum, immediate effects of successful performance interventions that result from the CQI Process should be evident in retention rates for FCP services over time because they are being delivered to more participants in larger doses, as indicated by more hours of attendance in TYRO Leadership and Core Communication workshops and higher workshop completion rates. Higher retention rates mean more participants acquire more knowledge from curriculum content to influence their attitudes about partner relationships.
- Being tested
- Family Champions Project Primary Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Champions Project Primary ServicesOther
Primary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula.
Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs.
| Study group | Role | What they receive |
|---|---|---|
| Primary Workshop Sessions | Experimental | Participants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours. Receives: Other: Family Champions Project Primary Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1: Retention Rates Among Participants
Do FCP participants exhibit higher retention rates (i.e., completion %) after cycles of CQI?
- Measured by program status (% active, complete, or not in program) as recorded on the nFORM online data collection system whose use is required by the funder to track programmatic data, such as enrollment and participation levels.
Count of participants who dropped out before CQI efforts began was obtained Count of participants who dropped out after CQI efforts began was obtained Count of participant completions before CQI efforts began was obtained Count of participant completions after CQI efforts began was obtained
Measured: through study completion, an average of six weeks
Secondary outcomes (1)
Secondary Outcome Measure 1: Partner Relationship Attitudes
Do FCP participants exhibit healthier partner relationship attitudes after enrolling in the program?
- 5 survey items measure the reported frequency of agreement with healthy partner relationship attitudes on a 4-point scale (1 'Strongly Agree', 2 'Agree', 3 'Disagree', 4, 'Strongly Disagree', NA 'Not Applicable').
- Lower scores on all items are positive (ex. - I want to grow old with my partner.)
The 5 items are measured as a construct. All items are added together and divided by 5 to create the construct score. The higher the score, the better the outcome.
maximum score of 5.0, minimum score of 1.0
Measured: pre to post completion which is 6 weeks longs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2021
- Primary completion1 Apr 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FathersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Evaluation & Research
- Sponsor type
- University, hospital or other
- Collaborators
- Anthem Strong Families
- Responsible party
- Sponsor
- Investigators
- Matt D Shepherd, PhD, Principal investigator, Midwest Evaluation & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298345
- Sponsor's protocol ID
- #2021/03/36
- Status last verified
- Nov 2025
- First submitted
- 28 Feb 2022
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be confidential and aggregated. No individual participant data will be released unless requested by the courts. This study looks at data as a whole.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of the Family Champions Project
- ClinicalTrials.gov ID
- NCT05298345
- Acronym / sponsor ID
- #2021/03/36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Midwest Evaluation & ResearchUniversity, hospital or other
- Collaborators
- Anthem Strong Families
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This evaluation uses a formative approach and a descriptive design with repeated measures to assess the efficacy of a Continuous Quality Improvement (CQI) Process to improve services delivered by the Family Champions Project (FCP). The FCP delivers education-based services-TYRO Leadership and Core Communication curricula-with funding from the Office of Family Assistance to low-income fathers and mothers to promote healthy family relationships and economic stability in their households. TYRO Leadership and Core Communication are adapted from the TYRO suite of curricula that were developed by the RIDGE Project, and they are designed to improve the relationships of families affected by the incarceration of a parent and the economic stability of their households. Participants must be at least 18 years of age with a child no older than 24 years and have no open criminal cases (cases can be deferred). Evaluation activities are carried out by Midwest Evaluation and Research (MER) and assess the extent to which our CQI Process is a feasible approach to improve outputs and the outcomes that might be associated with them for an education-based service delivery effort like the FCP.
Specifically, study results from formative evaluation will inform practitioners in the field of HMRE about the viability of using a CQI Process like ours to achieve full implementation and provide some evidence about its capacity to improve outcomes. Formative evaluation not only assesses experiences of the CQI Team and front-line service staff while implementing our CQI Process, but also pays attention to the timing and other specifics of any performance interventions that occur over the 5-year project. As a result, performance interventions present opportunities to conduct a series of mini studies to descriptively evaluate CQI Team efforts to improve implementation of the FCP. Performance trends that improve after an intervention indicate the CQI Team was likely successful to more fully implement outputs which should result in a positive effect on retention rates and, in turn, short term outcomes if we assume a sound theory of change for the FCP is depicted in the logic model.
Detailed description
Efforts to conduct CQI are in the early stages of development in the field of Healthy Marriage and Relationship Education (HMRE). The Office of Family Assistance (OFA) has required HMRE grantees to conduct CQI as part of project activities since funding began for them in 2006. However, HMRE grantees have likely not bought into the CQI Process given the absence of user-friendly conceptual frameworks to guide CQI efforts and empirical evidence to demonstrate they improve implementation of project activities and, in turn, enhance participant outcomes that might be attributed to them.
The CQI Process used in this study was developed by Dr. Theodore C. Jurkiewicz and then enhanced after starting work at MER, and it begins by forming a CQI-Team. The CQI-Team is a collaboration between practitioners with the authority to make implementation decisions about the FCP and evaluators at MER who handle data analyses and reporting.
The CQI Team carries out a multistep plan that is repeated each program year to fully implement FCP educational services over time by using a series of indicators to track performance trends for various outputs from a different perspective in each step. Percentage of target enrollment, percentage of target population that reflect eligibility characteristics, hours of dosage received by participants, response rates to participant surveys that measure outcomes among other indicators and outputs are tracked for monthly and quarterly enrollment cohorts in each program year and presented in CQI Reports that take the perspective associated with each of the steps. The CQI Team discusses findings presented by evaluators for overall performance trends in bi-weekly reports for the 1st step and performance trends by site in quarterly reports presented twice per year for steps 2 and 3. Then, members of the CQI-Team collaborate with front line service staff to develop interventions for any performance trend with an output that seems likely to fall short of standards by the end of the program year. Effects of interventions on outputs are reported by site in step 4.
Ultimately, successful performance interventions designed and implemented by the CQI Team in collaboration with front-line service staff should improve the outputs associated with FCP services over time, and the most immediate impact should be evident in participant retention rates. Interventions that lead to higher enrollment and then improved attendance should lead to a higher incidence of complete program status (active, complete, not in program), which means FCP services are being delivered to more participants in larger doses. Larger doses of services delivered to participants after performance interventions which means the CQI Team is facilitating progress to meet performance standards because participants receive the amounts of FCP services intended for them.
What is more, higher retention rates over time should lead to improved short-term outcomes for participants. Participants who receive larger doses of FCP services after performance interventions should acquire more knowledge in educational sessions than those who receive smaller doses. However, rigorous measures of participant knowledge are not available because it was not possible to get full access to proprietary curricula to develop them. Consequently, participant attitudinal changes will be the only focus for measuring short-term outcomes in this study. Attitudes change more quickly in healthy and productive ways after merely exposing participants to new ways of thinking about parenting, handling finances, or accessing employment with curriculum content in the FCP.
Finally, FCP services cannot determine participant outcomes but only contribute to them amongst a host of other factors, which makes it difficult for a descriptive study to link behavioral change to CQI efforts. Healthier and more productive behaviors take time to emerge, develop, and hopefully replace old behaviors because they are subject to a host of other influences on FCP participants. What is more, low-income individuals in the FCP target population, especially those who are parents, experience changing life circumstances more often than those from wealthier households that make them more vulnerable to a host of risk-related factors, such as unstable employment, tenuous housing situations, or limited sources of support that are available from family and friends. Changing life circumstances for low-income individuals make it more difficult for FCP services to have a positive, lasting impact on their behavior.
In sum, immediate effects of successful performance interventions that result from the CQI Process should be evident in retention rates for FCP services over time because they are being delivered to more participants in larger doses, as indicated by more hours of attendance in TYRO Leadership and Core Communication workshops and higher workshop completion rates. Higher retention rates mean more participants acquire more knowledge from curriculum content to influence their attitudes about partner relationships.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Workshop Sessions | Experimental | Other: Family Champions Project Primary ServicesParticipants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age 18 and older)
- Parent
- No open criminal cases (or deferred)
Key exclusion criteria (3 listed)
- Minor (under the age of 18)
- Not a parent
- Has an open criminal case (or not deferred)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Champions Project Primary ServicesPrimary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula. Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs. | Other | Primary Workshop Sessions |
Primary outcome
Primary Outcome Measure 1: Retention Rates Among Participants
Time frame: through study completion, an average of six weeks
Do FCP participants exhibit higher retention rates (i.e., completion %) after cycles of CQI? • Measured by program status (% active, complete, or not in program) as recorded on the nFORM online data collection system whose use is required by the funder to track programmatic data, such as enrollment and participation levels. Count of participants who dropped out before CQI efforts began was obtained Count of participants who dropped out after CQI efforts began was obtained Count of participant completions before CQI efforts began was obtained Count of participant completions after CQI efforts began was obtained
1 secondary outcome
Secondary Outcome Measure 1: Partner Relationship Attitudes
Time frame: pre to post completion which is 6 weeks longs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. All participant data will be confidential and aggregated. No individual participant data will be released unless requested by the courts. This study looks at data as a whole.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt D Shepherd, PhD principal investigator
Midwest Evaluation & Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Champions Project Primary Services in people with Fathers and Mothers, run by Midwest Evaluation & Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1: Retention Rates Among Participants (time frame: through study completion, an average of six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.