Father-Child RelationsNCT03069898
TRUE Dads: Evaluation of an Intervention Focusing on Father Involvement, Co-parenting, and Employment
A study testing TRUE Dads in people with Father-Child Relations, run by It's My Community Initiative at 1 site in United States.
Trial summary
With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program focuses on establishing or strengthening three of men's key roles in the family: 1) their role as providers, through fostering employment and economic self-sufficiency, 2) their role as fathers, in building and maintaining… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Father-Child Relations
- What is being tested?
- TRUE Dads
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,084 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- This study begins with a focus on fathers. We are initially recruiting men who:
- Are 18 or older
- Are residing in Oklahoma County/Metro
- Are expecting a child or already have a child age (0-12), with an emphasis on 0-6,
- Have spent time with the child the prior month (or with mother if expecting)
- Are English-speaking. Have not previously participated in the Family Expectations program offered by Public Strategies (Oklahoma) in the last 3 years
Who cannot join
- Because this an intervention for fathers that attempts to improve the relationship with the fathers' co-parent, we are accepting fathers only if the co-parent agrees to attend at least the first 6 workshops. In pilot trials, almost all the co-parents are women (wives, intimate partners, grandmothers), but a few are men (the fathers' father, brother, intimate partner)
- -
- Either or both partners have taken part in the Family Expectations project during the past three years, located in the same building, run by Public Strategies
Trial locations and contacts
1 site in 1 country.
United States1 site
It's My Community Initiative
Oklahoma City, Oklahoma, 73104
About this study
Official title: Evaluation of the TRUE Dads Intervention
With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program focuses on establishing or strengthening three of men's key roles in the family: 1) their role as providers, through fostering employment and economic self-sufficiency, 2) their role as fathers, in building and maintaining positive engagement with their children, and 3) their role in having and keeping a positive relationship with their co-parenting partner (wife, intimate partner, or other co-parent). The study is a randomized clinical trial that compares participants in a program track with participants a study track (no treatment control group) over a one-year period.
Read the detailed description
Interventions to strengthen men's roles as providers, as fathers, and as co-parents have typically been addressed in separate intervention and research silos. The TRUE Dads program proposes a unique integration of employment, fathering, and co-parenting services, with the overarching goal of strengthening fathers and the family unit by: 1) increasing fathers' economic stability and self-sufficiency, 2) enhancing the quantity and quality of father's engagement with their children, 3) improving the quality of the collaborative relationship between fathers and mothers or men and their co-parenting partners, 4) improving the relationship quality of fathers in their intimate partner relationships (with the co-parent or new partner), and 5) positively affecting children's behavior and development.
Twelve hundred fathers will be recruited for the study. After an initial interview of the fathers and their co-parenting partners, who will complete Baseline survey, 720 of the 1,200 fathers and co-parents will be assigned to the TRUE Dads intervention (Program track), and 480 to a no-treatment control condition (Study track). Participants will be informed that the program consists of participation in a series of 12 three-hour meetings. Those 12 sessions include six meetings covering a core fatherhood curriculum, attended with the co-parent, combined with one of three intensives selected by the father: a) six sessions with an emphasis on employment, b) six sessions with an emphasis on building healthy romantic relationships with the co-parent, or c) six sessions with an emphasis on parenting with a participating co-parent. Participants in the Program track may be referred for additional employment, mental health, or other needed services. Both program and control participants (fathers and co-parents) will fill out a Follow-up survey one year from their entrances into the study.
- Conditions
- Father-Child Relations
- Being tested
- TRUE Dads
- Keywords
- Marital relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUE DadsBehavioural
The TRUE Dads intervention consists of a set of 12 3-hour workshops that focus on enhancing fathers' role as co-parent, parent, and provider
| Study group | Role | What they receive |
|---|---|---|
| TRUE Dads program track | Experimental | In the TRUE Dads program, fathers and co-parents begin with a Core workshop meeting weekly for 6 weeks. After a check-in, a male-female group leader team focuses on a single topic that represents one of the three main goals of the project as a whole: Co-parenting relationships, Parenting, or Employment and financial stability. From 10 to 18 couples, seated at small tables in a large room, hear mini-lectures, watch videos, and engage in interactive exercises. Fathers then choose to attend one of three intensive workshops focused on couple relationships OR parenting OR economic self-sufficiency meeting 3 hours per week for the next 6 weeks. On an as-needed basis, fathers may be referred for employment programs and fathers and co-parents may be referred for mental health or other services. Receives: Behavioral: TRUE Dads |
| Control condition study track | No intervention | Participants (fathers and co-parents) complete intake interview and fill out Baseline survey. They fill out follow-up survey one year later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Father/Co-parent relationship quality
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing perceptions of co-parent relationship quality, communication and conflict management abilities. High scores indicate relationship distress.
Measured: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Father involvement
This outcome will be measured by a composite of self-report survey items filled out by both fathers and co-parents, assessing fathers' involvement in childcare tasks, time spent in specific activities with target child, parenting styles, and parenting behaviors. High scores indicate positive father involvement
Measured: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Child well-being
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing child temperament, externalizing behavior problems (aggression, hyperactivity) and internalizing behavior problems (anxiety, depression, shy/withdrawn behavior). High scores indicate more behavior problems.
Measured: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Economic Self-sufficiency
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing employment status, income, behaviors to find a job or acquire new job skills. High scores indicate more positive economic achievements and more positive attitudes
Measured: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Parents adjustment and distress
This outcome will be measured by a composite of self-report measures of symptoms of depression (Center for Epidemiological Studies in Depression, CES-D) and anxiety (from the Brief Symptom Inventory). High scores indicate personal distress.
Measured: change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jul 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Father-Child RelationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paraticipants are randomly assigned to intervention (TRUE Dads) and Control tracks, assessed at Baseline and again one year later. The intervention primarily involves attendance at 12 3-hour workshops for fathers and their co-parents.
- Masking
- None (open label)
- Enrolment
- 2,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- It's My Community Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip A. Cowan, It's My Community Initiative
- Investigators
- Philip A. Cowan, PhD, Principal investigator, It's My Community Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069898
- Sponsor's protocol ID
- 2016-08-9047
- Status last verified
- Aug 2020
- First submitted
- 28 Feb 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cowan PA, Cowan CP, Gillette PF. TRUE Dads: The impact of a couples-based fatherhood intervention on family relationships, child outcomes, and economic self-sufficiency. Fam Process. 2022 Sep;61(3):1021-1044. doi: 10.1111/famp.12748. Epub 2022 Jan 10.
PubMed 35014030
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the TRUE Dads Intervention
- ClinicalTrials.gov ID
- NCT03069898
- Acronym / sponsor ID
- 2016-08-9047
- Conditions
- Father-Child Relations
- Keywords
- Marital relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,084 participants (actual)
- Lead sponsor
- It's My Community InitiativeUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program focuses on establishing or strengthening three of men's key roles in the family: 1) their role as providers, through fostering employment and economic self-sufficiency, 2) their role as fathers, in building and maintaining positive engagement with their children, and 3) their role in having and keeping a positive relationship with their co-parenting partner (wife, intimate partner, or other co-parent). The study is a randomized clinical trial that compares participants in a program track with participants a study track (no treatment control group) over a one-year period.
Detailed description
Interventions to strengthen men's roles as providers, as fathers, and as co-parents have typically been addressed in separate intervention and research silos. The TRUE Dads program proposes a unique integration of employment, fathering, and co-parenting services, with the overarching goal of strengthening fathers and the family unit by: 1) increasing fathers' economic stability and self-sufficiency, 2) enhancing the quantity and quality of father's engagement with their children, 3) improving the quality of the collaborative relationship between fathers and mothers or men and their co-parenting partners, 4) improving the relationship quality of fathers in their intimate partner relationships (with the co-parent or new partner), and 5) positively affecting children's behavior and development.
Twelve hundred fathers will be recruited for the study. After an initial interview of the fathers and their co-parenting partners, who will complete Baseline survey, 720 of the 1,200 fathers and co-parents will be assigned to the TRUE Dads intervention (Program track), and 480 to a no-treatment control condition (Study track). Participants will be informed that the program consists of participation in a series of 12 three-hour meetings. Those 12 sessions include six meetings covering a core fatherhood curriculum, attended with the co-parent, combined with one of three intensives selected by the father: a) six sessions with an emphasis on employment, b) six sessions with an emphasis on building healthy romantic relationships with the co-parent, or c) six sessions with an emphasis on parenting with a participating co-parent. Participants in the Program track may be referred for additional employment, mental health, or other needed services. Both program and control participants (fathers and co-parents) will fill out a Follow-up survey one year from their entrances into the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paraticipants are randomly assigned to intervention (TRUE Dads) and Control tracks, assessed at Baseline and again one year later. The intervention primarily involves attendance at 12 3-hour workshops for fathers and their co-parents.
| Arm | Type | Receives |
|---|---|---|
| TRUE Dads program track | Experimental | Behavioral: TRUE DadsIn the TRUE Dads program, fathers and co-parents begin with a Core workshop meeting weekly for 6 weeks. After a check-in, a male-female group leader team focuses on a single topic that represents one of the three main goals of the project as a whole: Co-parenting relationships, Parenting, or Employment and financial stability. From 10 to 18 couples, seated at small tables in a large room, hear mini-lectures, watch videos, and engage in interactive exercises. Fathers then choose to attend one of three intensive workshops focused on couple relationships OR parenting OR economic self-sufficiency meeting 3 hours per week for the next 6 weeks. On an as-needed basis, fathers may be referred for employment programs and fathers and co-parents may be referred for mental health or other services. |
| Control condition study track | No intervention | –Participants (fathers and co-parents) complete intake interview and fill out Baseline survey. They fill out follow-up survey one year later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 or older
- Are residing in Oklahoma County/Metro
- Are expecting a child or already have a child age (0-12), with an emphasis on 0-6,
- Have spent time with the child the prior month (or with mother if expecting)
- Are English-speaking. Have not previously participated in the Family Expectations program offered by Public Strategies (Oklahoma) in the last 3 years
Key exclusion criteria (3 listed)
- Because this an intervention for fathers that attempts to improve the relationship with the fathers' co-parent, we are accepting fathers only if the co-parent agrees to attend at least the first 6 workshops. In pilot trials, almost all the co-parents are women (wives, intimate partners, grandmothers), but a few are men (the fathers' father, brother, intimate partner)
- -
- Either or both partners have taken part in the Family Expectations project during the past three years, located in the same building, run by Public Strategies
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 |
|---|---|---|
| TRUE DadsThe TRUE Dads intervention consists of a set of 12 3-hour workshops that focus on enhancing fathers' role as co-parent, parent, and provider | Behavioural | TRUE Dads program track |
Primary outcome
Father/Co-parent relationship quality
Time frame: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing perceptions of co-parent relationship quality, communication and conflict management abilities. High scores indicate relationship distress.
Father involvement
Time frame: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
This outcome will be measured by a composite of self-report survey items filled out by both fathers and co-parents, assessing fathers' involvement in childcare tasks, time spent in specific activities with target child, parenting styles, and parenting behaviors. High scores indicate positive father involvement
Child well-being
Time frame: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing child temperament, externalizing behavior problems (aggression, hyperactivity) and internalizing behavior problems (anxiety, depression, shy/withdrawn behavior). High scores indicate more behavior problems.
Economic Self-sufficiency
Time frame: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
This outcome will be measured by a composite of self-report survey items filled out by fathers and co-parents, assessing employment status, income, behaviors to find a job or acquire new job skills. High scores indicate more positive economic achievements and more positive attitudes
Parents adjustment and distress
Time frame: change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
This outcome will be measured by a composite of self-report measures of symptoms of depression (Center for Epidemiological Studies in Depression, CES-D) and anxiety (from the Brief Symptom Inventory). High scores indicate personal distress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 35014030Cowan PA, Cowan CP, Gillette PF. TRUE Dads: The impact of a couples-based fatherhood intervention on family relationships, child outcomes, and economic self-sufficiency. Fam Process. 2022 Sep;61(3):1021-1044. doi: 10.1111/famp.12748. Epub 2022 Jan 10.
- Individual participant dataSharing planned: Undecided
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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.
Philip A. Cowan, PhD principal investigator
It's My Community Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUE Dads in people with Father-Child Relations, run by It's My Community Initiative 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 6 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 26 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Father/Co-parent relationship quality (time frame: Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069898, which also lists 1 linked publication.
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 26 Aug 2020.