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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03058549
Other study ID # 860135
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 30, 2020

Study information

Verified date September 2020
Source Public Strategies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the effectiveness of a program to strengthen the relationships of disadvantaged expectant couples, and to increase co-parenting, father involvement, and economic stability. Couples are randomly assigned to Family Expectations or a control group, and assessed at baseline and one year.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2640
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 to 100 Years
Eligibility Inclusion Criteria:

1. Both partners are willing to participate

2. Partners have a commitment to be together as a couple

3. Both partners are the biological parents of a child in a current pregnancy or of a child born within the past 3 months

4. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Expectations
Relationship education and referral services for expectant couples.

Locations

Country Name City State
United States Public Strategies Oklahoma City Oklahoma

Sponsors (3)

Lead Sponsor Collaborator
Public Strategies Children's Bureau - Administration for Children and Families, University of Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship adjustment 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.
Primary Relationship stability Couple remains romantically involved. Self-reported by survey methods. 1 year post baseline
Primary Individual wellbeing Symptoms of depression and anxiety. Respondents will self-report using survey methods. Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
Primary Co-parenting quality The quality of the co-parenting relationship between the expectant partners will be self-reported using survey methods. 1 year post baseline.
Primary Child outcomes Infant temperament and wellbeing will be assessed by parent self-report using survey methods. 1 year post baseline.
Primary Interaction quality 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. Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
Secondary Changes in Income Income will be measured by self-report using survey methods. Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.
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