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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03413709
Other study ID # 201605068
Secondary ID
Status Recruiting
Phase N/A
First received September 28, 2016
Last updated January 22, 2018
Start date July 1, 2016
Est. completion date September 30, 2020

Study information

Verified date January 2018
Source Fathers' Support Center, St. Louis
Contact Sarah Bobmeyer, MSW
Phone 314-935-3723
Email sbobmeyer@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Fathers' Support Center, in partnership with the Brown School Evaluation Center at Washington University in St. Louis, seeks to evaluate the impact of their New Pathways to Responsible Fatherhood Family Formation Program (NPFF). The investigators are most interested in quantifying the added benefit of parenting, father-child engagement, and father well-being curriculum compared to course content containing 80 hour economic stability material only. The impact evaluation will answer four key outcome and implementation specific questions using a mixed methods approach. Participants will be randomly assigned to one of two groups (full program or 80 hour economic stability curriculum only) and tracked for the duration of the program. The impact evaluation tools include a set of validated instruments and will be administered to participants at baseline and again at three and twelve months after completion of the program. Performance measurement data will also be included in our analysis. Investigators hypothesize that participation in the full program will have a greater effect on key outcomes than the economic stability curriculum, a similar number of families will be reached by each condition, and that there will be minimal variability in retention rates across groups.


Description:

Research Questions

The Brown School Evaluation Center at Washington University in St. Louis will conduct the local impact evaluation. The local evaluation seeks to answer four primary questions pertaining to the implementation and outcomes of the Family Formation Program (FFP) (an integrated approach of responsible parenting, economic stability and mobility, and healthy relationships):

Outcome Q1: Does the participation of fathers in the comprehensive Family Formation Program have greater effect on family functioning, father and child outcomes, and father economic stability and mobility compared to fathers receiving the 80 hour economic stability services only (i.e., job readiness and employment skills)?

Implementation Q2: How many families were reached by each of the conditions and was there variability in retention rates of fathers across conditions?

Implementation Q3: Did fathers in the treatment and comparison conditions find the intervention to be acceptable and appropriate?

Implementation Q4: What barriers and benefits exist to successful implementation of father focused family support programs?

Background Fatherhood programs originally had a narrow focus on financial stability and support, but have recently evolved to also emphasize healthy relationships, parenting skills, and father involvement. Despite significant state and federal funding for fatherhood programs, few have undergone rigorous evaluation to examine their effectiveness. This evaluation will determine the added benefit of content on parenting, father-child engagement, and father well-being over and above content on economic stability and mobility, in relation to family functioning, child well-being, and economic stability. This will also further build the evidence supporting one particular comprehensive intervention, FFP, as a means to improve outcomes for children and families through intervening with fathers.

Relation to program logic model The primary research question of this impact evaluation will examine the effect of the FFP on short- and long-term outcomes as described in the FFP logic model

Short-term outcomes assessed by the impact evaluation will include:

1. improved parenting and co-parenting skills;

2. increased father-child engagement;

3. increased financial responsibility of fathers; and

4. progress towards greater economic stability.

The impact evaluation will also examine the FFP long-term outcomes of improved family functioning (through changes in father and child well-being; co-parenting relationship quality, and the father-child relationship) and increased economic stability and mobility.

Hypothesis:

Investigators believe that the FFP will have a greater effect on family functioning, father and child outcomes, and father economic stability compared to fathers in the comparison group because members of the treatment group will be receiving a more comprehensive range of services. Investigators anticipate that fathers will equally participate in both programs because both will provide meaningful information and opportunities to build their skill sets.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date September 30, 2020
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years and older
Eligibility Inclusion Criteria:

- being a father (biological or step) with at least one child 16 years old or younger

Exclusion Criteria:

- no presence of a restraining order from mother or child

- is not currently incarcerated

- is not homeless

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Family Formation Program
The sample for the treatment group for the impact evaluation will only include fathers who are receiving the full 240 hour FFP program (and not the abbreviated 80 hour program). The treatment group will receive FSC's Family Formation Program, which is a six week, 240 hour program implementing a set of curricula focusing on responsible parenting, healthy relationships, and economic stability and mobility.

Locations

Country Name City State
United States Fathers Support Center, St. Louis INC. Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Fathers' Support Center, St. Louis Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Father Engagement-Father Research & Practice Network (FRPN) Father Engagement Scale Brief instrument designed to assess fathers' engagement with children at different ages. Separate scales for fathers of children ages 0-1 years, 1-5 years, 6-12 years, and adolescents. Scales found to have good reliability and validity 1 year from program completion
Primary Father Child Contact-nForm Survey Pre- and post-program nForm survey items related to father-child contact will be used to evaluate this construct. 1 year from program completion
Primary Child Behavior and Emotion-Child Behavior Checklist (CBCL) Standardized instrument based on national norms that assesses child behavioral and emotional problems. Study will use anxious/depressed and aggressive behavior sub-scales. 1 year from program completion
Primary Parental Health-SF12v2 Health Survey 12-item nationally-normed health survey that measures functional health and well-being from the patient's point of view. 1 year from program completion
Primary Parental Substance Abuse-Alcohol Use Disorder Identification Test (AUDIT) 10-item screening tool developed by World Health Organization to assess alcohol use, alcohol dependence, and alcohol-related problems. Its reliability and validity have been established in research conducted in a variety of settings 1 year from program completion
Primary Parental Consequences related to Drug Abuse-Drug Abuse Screening Test 10 (DAST-10) Brief instrument that yields a quantitative index of the degree of consequences related to drug abuse. Literature has shown moderate to high reliability and validity 1 year from program completion
Primary Parental Discipline Strategies/Behavior-Conflict Tactics Scale-Parent Child (CTSPC) Well-established instrument used to assess physical and psychological maltreatment. Study will use minor assault and non-violent discipline sub-scale items only 1 year from program completion
Primary Co-parenting Relationships-FRPN: Coparenting Relationship Scale 11-item measure designed to assess fathers' coparenting relationships with the mother of their children. The measure was validated with a sample of fathers very similar to those served in U.S. responsible fatherhood programs 1 year after completion
Primary Child/Financial Support Behavior-FSC Intake Survey Items from FSC intake survey related to child and financial support will be used to assess this construct. 1 year after program completion
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