HealthyReFORMNCT02860988
Responsible Fatherhood Opportunities for Reentry & Mobility
A study testing MCCC treatment in people with Healthy, run by Mountain Comprehensive Care Center at 1 site in United States.
Trial summary
The purpose of this study is to determine differences among incarcerated or recently incarcerated fathers who receive targeted services and those who do not. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Healthy
- What is being tested?
- MCCC treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 31 May 2020
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male inmates at specific eastern Kentucky jail sites who are at least 18 years of age and not previously screened for the study
- Participants for the local evaluation will be identified as eligible fathers who have been tried and convicted as an adult; within 3 to 9 months of release; are low-income; and may be an expectant father, a biological father, an adoptive father or a stepfather or who a person who is acknowledged as a father figure (e.g., grandfather) of a dependent child or young adult child up to 24 years of age, and interested in participation.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine differences among incarcerated or recently incarcerated fathers who receive targeted services and those who do not.
Read the detailed description
Individuals with a criminal justice background (either incarcerated or on community supervision) and substance use issues will have the opportunity to enroll in services provided by the Mountain Comprehensive Care Center to focus on enhancing fatherhood and family situations.
The primary research questions focus on gauging the intervention's effectiveness in improving healthy relationship and responsible fatherhood outcomes. The intervention has several components targeting parenting skills, job training, relationship education, and case management/reentry support. Primary research questions include:
- Compared to the counterfactual condition, what is the impact of the intervention on parenting and co-parenting skills/behaviors, as measured by parental role satisfaction and confidence in parenting skills six months after release from incarceration?
- Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be employed six months after release from incarceration?
- Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be in a relationship six months after release from incarceration?
- Conditions
- Healthy
- Being tested
- MCCC treatment
- Keywords
- Fatherhood, Relationships, Employment, Criminal Justice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCCC treatmentBehavioural
Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
| Study group | Role | What they receive |
|---|---|---|
| MCCC Treatment | Experimental | Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships. Receives: Behavioral: MCCC treatment |
| MCCC Comparison | No intervention | Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Role Satisfaction
A scale calculated by summing three times measuring happiness, closeness, and comforting interactions with the child. Total score range is 3-12, with higher scores indicating greater satisfaction.
Measured: 6-month follow-up
Number of Participants Employed
The outcome is a dichotomous indicator of whether the participant currently has a job.
Measured: 6-month follow-up
Number of Participants in a Relationship
The outcome measure is a dichotomous indicator of whether the participant is currently in a relationship.
Measured: 6-month follow-up
Secondary outcomes (5)
Number of Participants With Recent In-person Contact With Child(Ren)
The measure is a dichotomous indicator of whether the participant has seen their child in person during the past month.
Measured: 6-month follow-up
Number of Participants With Recent Other Contact With Child(Ren)
The measure is a dichotomous indicator of whether the participant has spoken with their child on the phone or sent their child letters within the past month.
Measured: 6-month follow-up
Number of Participants That Participated in an Education or Job Training Program in the Past 30 Days
The measure is a dichotomous indicator of whether the participant has participated in education or job training programs within the past month.
Measured: 6-month follow-up
Partner Conflict Resolution
The measure is a Likert-type (very/somewhat/not at all satisfied) response to whether the participant is satisfied with the way that they and their partner/spouse handle conflict. Total scores range 1-3, with higher scores indicating a greater level of satisfaction.
Measured: 6-month follow-up
Mental Health Distress
The outcome measure is a scale calculated from six items measuring symptoms of anxiety and depression experienced in the past month. Total scores range from 6-30,w with higher scores indicating more frequent experience with symptoms (i.e., greater distress).
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 May 2020
- Study completion31 May 2020
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 HealthyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Comprehensive Care Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860988
- Sponsor's protocol ID
- 90FO0007-01-00
- Acronym
- ReFORM
- Status last verified
- Apr 2021
- First submitted
- 2 Aug 2016
- Last updated
- 30 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsible Fatherhood Opportunities for Reentry & Mobility
- ClinicalTrials.gov ID
- NCT02860988
- Acronym / sponsor ID
- ReFORM / 90FO0007-01-00
- Conditions
- Healthy
- Keywords
- Fatherhood, Relationships, Employment, Criminal Justice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Mountain Comprehensive Care CenterUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 30 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine differences among incarcerated or recently incarcerated fathers who receive targeted services and those who do not.
Detailed description
Individuals with a criminal justice background (either incarcerated or on community supervision) and substance use issues will have the opportunity to enroll in services provided by the Mountain Comprehensive Care Center to focus on enhancing fatherhood and family situations.
The primary research questions focus on gauging the intervention's effectiveness in improving healthy relationship and responsible fatherhood outcomes. The intervention has several components targeting parenting skills, job training, relationship education, and case management/reentry support. Primary research questions include:
- Compared to the counterfactual condition, what is the impact of the intervention on parenting and co-parenting skills/behaviors, as measured by parental role satisfaction and confidence in parenting skills six months after release from incarceration?
- Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be employed six months after release from incarceration?
- Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be in a relationship six months after release from incarceration?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCCC Treatment | Experimental | Behavioral: MCCC treatmentParticipants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships. |
| MCCC Comparison | No intervention | –Participants in this condition did not receive reentry services related to responsible parenting, economic stability and mobility, or healthy marriage and relationships. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male inmates at specific eastern Kentucky jail sites who are at least 18 years of age and not previously screened for the study
- Participants for the local evaluation will be identified as eligible fathers who have been tried and convicted as an adult; within 3 to 9 months of release; are low-income; and may be an expectant father, a biological father, an adoptive father or a stepfather or who a person who is acknowledged as a father figure (e.g., grandfather) of a dependent child or young adult child up to 24 years of age, and interested in participation.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| MCCC treatmentParticipants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships. | Behavioural | MCCC Treatment |
Primary outcome
Parental Role Satisfaction
Time frame: 6-month follow-up
A scale calculated by summing three times measuring happiness, closeness, and comforting interactions with the child. Total score range is 3-12, with higher scores indicating greater satisfaction.
Number of Participants Employed
Time frame: 6-month follow-up
The outcome is a dichotomous indicator of whether the participant currently has a job.
Number of Participants in a Relationship
Time frame: 6-month follow-up
The outcome measure is a dichotomous indicator of whether the participant is currently in a relationship.
5 secondary outcomes
Number of Participants With Recent In-person Contact With Child(Ren)
Time frame: 6-month follow-up
Number of Participants With Recent Other Contact With Child(Ren)
Time frame: 6-month follow-up
Number of Participants That Participated in an Education or Job Training Program in the Past 30 Days
Time frame: 6-month follow-up
Partner Conflict Resolution
Time frame: 6-month follow-up
Mental Health Distress
Time frame: 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCCC treatment in people with Healthy, run by Mountain Comprehensive Care Center 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 2 inclusion and 1 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 30 Apr 2021. 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 30 Apr 2021). 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?
Parental Role Satisfaction (time frame: 6-month follow-up). The study lists 3 primary outcomes in all. 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 30 Apr 2021.