TRUE Dads: Evaluation of an Intervention Focusing on Father Involvement, Co-parenting, and Employment

August 24, 2020 updated by: Philip A. Cowan, It's My Community Initiative

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2084

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • It's My Community Initiative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

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)

-

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TRUE Dads program track
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.
Behavioral: TRUE Dads
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
NO_INTERVENTION: Control condition study track
Participants (fathers and co-parents) complete intake interview and fill out Baseline survey. They fill out follow-up survey one year later

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
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
Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
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.
Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
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
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
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.
change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
It's My Community Initiative

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philip A. Cowan, PhD, It's My Community Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-08-9047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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