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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03069898
Other study ID # 2016-08-9047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date June 30, 2020

Study information

Verified date August 2020
Source It's My Community Initiative
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2084
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States It's My Community Initiative Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
It's My Community Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Primary 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 Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Primary 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. Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Primary 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 Change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
Primary 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. change or maintenance of positive behavior relative to the control group will be assessed at Baseline and 1 year post Baseline.
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