Impact Evaluation of Family Expectations: A Program to Strengthen the Relationships of Disadvantaged Expectant Couples

September 14, 2020 updated by: Galena Rhoades, Public Strategies

Family Expectations: Impact Evaluation of Program for Expectant Couples

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.

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

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

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.
2640

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
        • Public Strategies

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: 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.
Behavioral: Family Expectations
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).

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
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.
Relationship stability
Time Frame: 1 year post baseline
Couple remains romantically involved. Self-reported by survey methods.
1 year post baseline
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.
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.
Co-parenting quality
Time Frame: 1 year post baseline.
The quality of the co-parenting relationship between the expectant partners will be self-reported using survey methods.
1 year post baseline.
Child outcomes
Time Frame: 1 year post baseline.
Infant temperament and wellbeing will be assessed by parent self-report using survey methods.
1 year post baseline.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.

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.
Public Strategies

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Bureau - Administration for Children and Families
University of Denver

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: Galena K Rhoades, Ph.D., University of Denver

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.
June 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 10, 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.
February 15, 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.
February 23, 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.
September 16, 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.
September 14, 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.
September 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.
  • 860135

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.

Clinical Trials on Parenting

Clinical Trials on Family Expectations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings