- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03058549
Impact Evaluation of Family Expectations: A Program to Strengthen the Relationships of Disadvantaged Expectant Couples
Family Expectations: Impact Evaluation of Program for Expectant Couples
Study Overview
Status
Intervention / Treatment
Detailed Description
The birth of a child can trigger relationship distress and dissolution. Family Expectations (FE) targets the transition to parenthood as a critical time to help couples focus on family success. Regardless of whether couples are married or unmarried, the goal of FE is to strengthen relationships and advance the well-being of economically disadvantaged couples who are expecting a baby or who are new parents, and to improve the lives of their children. The FE program, including the Becoming Parents (BP) curriculum and supplemental services, is designed to address specific risk factors that affect individual family members and the relationships among them, and to build protective factors that help families avoid, minimize, or manage risks (e.g., individual maladaptation [mother, father, child], couple relationship difficulties, parenting difficulties, and economic insufficiency).
A total of 1,355 couples will be randomly assigned to either Family Expectations (n = 813; 60%) or an untreated control group (n = 542; 40%). Once assigned, participants in the study will complete baseline questions by survey. Those assigned to the FE track will be scheduled for services with the FE intervention team and the control group will not receive the FE intervention. Members of the intervention and control groups will be surveyed both before they are randomly assigned and 12 months later. The study will examine if the Family Expectations program is associated with improved outcomes on relationship quality, stability, parenting quality, father involvement, child wellbeing, and hopefulness about employment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Public Strategies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both partners are willing to participate
- Partners have a commitment to be together as a couple
- Both partners are the biological parents of a child in a current pregnancy or of a child born within the past 3 months
- Fluent in English (study and intervention materials are in English)
Exclusion Criteria:
1. Either or both partners have taken part in Family Expectations services before
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention: Family Expectations
Family Expectations includes 36 hours of relationship education and parenting content, coaching sessions for couples, and group case management/referral information about local resources.
Each couple will also complete an initial case management assessment, followed by referrals to any needed services, such as employment, substance abuse, mental health, housing, etc.
Based on need, couples will have the option of additional case management/coaching services during their involvement in Family Expectations.
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Relationship education and referral services for expectant couples.
|
|
No Intervention: Control Group
The control group will not receive the intervention though they are able to seek and obtain any services they wish in the community (Treatment as Usual).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship adjustment
Time Frame: Baseline and 1 year post baseline (to assess change over time). Change (or maintenance) relative to control group will be assessed across the two time points.
|
This outcome will be measured by a composite of measures to relationship quality (support and affection, global relationship satisfaction, and confidence in the future of the relationship).
Respondents will self-report using survey methods.
|
Baseline and 1 year post baseline (to assess change over time). Change (or maintenance) relative to control group will be assessed across the two time points.
|
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Relationship stability
Time Frame: 1 year post baseline
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Couple remains romantically involved.
Self-reported by survey methods.
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1 year post baseline
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Individual wellbeing
Time Frame: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
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Symptoms of depression and anxiety.
Respondents will self-report using survey methods.
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Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
|
|
Co-parenting quality
Time Frame: 1 year post baseline.
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The quality of the co-parenting relationship between the expectant partners will be self-reported using survey methods.
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1 year post baseline.
|
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Child outcomes
Time Frame: 1 year post baseline.
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Infant temperament and wellbeing will be assessed by parent self-report using survey methods.
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1 year post baseline.
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Interaction quality
Time Frame: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
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This outcome will be measured by a composite of measures that assess communication and conflict management abilities (communication skills, constructive conflict management, destructive conflict management).
Respondents will self-report using survey methods.
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Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Income
Time Frame: Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.
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Income will be measured by self-report using survey methods.
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Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Galena K Rhoades, Ph.D., University of Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 860135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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