Impact Evaluation of MotherWise Program

April 20, 2022 updated by: Mathematica Policy Research, Inc.

Strengthening Relationship Education and Marriage Services - Impact Evaluation of MotherWise Program

Mathematica was awarded a contract by ACF to conduct the evaluation of selected grantees offering Healthy Marriage and Relationship Education Programs.This particular evaluation will focus on the University of Denver's MotherWise program, which offers relationship education and other supports to low-income women expecting a baby. The program has three core components: (1) 18 hours of core workshop sessions using the Within My Reach relationship education curriculum supplemented with content on mother-infant relationships; (2) case management services; and (3) optional relationship education workshops for couples. The evaluation will test the effect of this full package of services on mothers' relationship outcomes, as well as other outcomes related to child well-being, such as co-parenting and father involvement.

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 U.S. Department of Health and Human Services (HHS), Administration for Children and Families (ACF), is conducting an evaluation of healthy marriage and relationship education (HMRE) programs. Mathematica was awarded a contract by ACF to conduct the evaluation of selected programs/grantees.This segment of the larger evaluation will focus on the University of Denver's MotherWise program.

The Mother Wise program will offer relationship education and other supports to low-income women expecting a baby. The program will have three core components: (1) 18 hours of core workshop sessions using the Within My Reach relationship education curriculum supplemented with content on mother-infant relationships; (2) case management services; and (3) optional relationship education workshops for couples. The evaluation will test the effect of this full package of services on mothers' relationship outcomes, as well as other outcomes related to child well-being, such as co-parenting and father involvement. If feasible, the evaluation will also examine some measures available through hospital records, such as birth weight.

Mother Wise will enroll women who are expecting a baby and those who have had a baby within the past month.

Control group members will not be eligible for Mother Wise but will be eligible for other services available in the community.

To document the outcomes of study participants, survey data will be collected at two time points: (1) a baseline survey administered at study enrollment, a (2) a 12-month follow-up survey, and (3) a 30-month follow-up survey. Surveys will be conducted by staff at Mathematica's Survey Operations Center using computer-assisted telephone interviewing (CATI). Survey data may be supplemented with administrative records data from the Denver Health system.

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.
953

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
    • Colorado
      • Denver, Colorado, United States, 80208
        • University of Denver

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

To be eligible, women must be expecting a baby or had a baby in the past 3 months.

Exclusion Criteria:

To be eligible, women must not be incarcerated.

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: MotherWise Programming
Three components: (1) 18 hours of core workshop sessions using the Within My Reach relationship education curriculum supplemented with content on mother-infant relationships; (2) case management services; and (3) optional relationship education workshops for couples.
Behavioral: MotherWise Program
Healthy Marriage or Relationship Education services for pregnant women.
No Intervention: Control
No program services

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
Perceived romantic relationship skills
Time Frame: 1 year after random assignment
Six-item scale (ranges from 1 to 4)
1 year after random assignment
Perceived romantic relationship skills
Time Frame: 30 months after random assignment
Six-item scale (ranges from 1 to 4)
30 months after random assignment
Perceived conflict management skills
Time Frame: 1 year after random assignment
Five-item scale (ranges from 1 to 4)
1 year after random assignment
Perceived conflict management skills
Time Frame: 30 months after random assignment
Five-item scale (ranges from 1 to 4)
30 months after random assignment
Support for going slow in romantic relationships
Time Frame: 1 year after random assignment
One-item scale (ranges from 1 to 4)
1 year after random assignment
Support for going slow in romantic relationships
Time Frame: 30 months after random assignment
One-item scale (ranges from 1 to 4)
30 months after random assignment
Disapproval of couple violence
Time Frame: 1 year after random assignment
Five-item scale (ranges from 1 to 4)
1 year after random assignment
Disapproval of couple violence
Time Frame: 30 months after random assignment
Five-item scale (ranges from 1 to 4)
30 months after random assignment
Any psychological abuse
Time Frame: 1 year after random assignment
A binary variable equal to 1 if the mother indicates that a romantic partner has subjected her to psychological abuse in the past year.
1 year after random assignment
Any psychological abuse
Time Frame: 30 months after random assignment
A binary variable equal to 1 if the mother indicates that a romantic partner has subjected her to psychological abuse in the past year.
30 months after random assignment
Any physical abuse
Time Frame: 1 year after random assignment
A binary variable equal to 1 if the mother indicates that a romantic partner has pushed, shoved, kicked, punched or beaten her up in the past year.
1 year after random assignment
Any physical abuse
Time Frame: 30 months after random assignment
A binary variable equal to 1 if the mother indicates that a romantic partner has pushed, shoved, kicked, punched or beaten her up in the past year.
30 months after random assignment
Had an unintended pregnancy since program enrollment
Time Frame: 1 year after random assignment
A binary variable equal to 1 if the mother reported having had an unintended pregnancy since random assignment.
1 year after random assignment
Had an unintended pregnancy since program enrollment
Time Frame: 30 months after random assignment
A binary variable equal to 1 if the mother reported having had an unintended pregnancy since random assignment.
30 months after random assignment
Quality of co-parenting relationship with baby's father
Time Frame: 1 year after random assignment
Ten-item scale (ranges from 0 to 10)
1 year after random assignment
Quality of co-parenting relationship with baby's father
Time Frame: 30 months after random assignment
Ten-item scale (ranges from 0 to 10)
30 months after random assignment
Depressive symptoms
Time Frame: 1 year after random assignment
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
1 year after random assignment
Depressive symptoms
Time Frame: 30 months after random assignment
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
30 months after random assignment
Number of relationship transitions
Time Frame: 30 months after random assignment
This is a continuous variable representing the number of relationship transitions the mother reported since random assignment. A relationship transition occurs each time a romantic relationship begins or ends.
30 months after random assignment
Material hardship
Time Frame: 30 months after random assignment
This continuous variable ranges from 0 to 6 and reflects how many of six possible things a mother had done in the past year because she did not have enough money.
30 months after random assignment
Child social-emotional and behavioral problems
Time Frame: 30 months after random assignment
This 31-item scale is a measure of the child's social-emotional and behavioral problems with higher scores indicating more problems.
30 months after random assignment
Child social-emotional abilities
Time Frame: 30 months after random assignment
This 11-item scale is a measure of the child's social-emotional abilities-such as empathy, prosocial behaviors, and compliance-with higher scores indicating higher competence.
30 months after random assignment

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.
Mathematica Policy Research, Inc.

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.
Department of Health and Human Services

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: Robert Wood, PhD, Mathematica Policy Research

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

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.
September 1, 2016

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.
September 1, 2021

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.
September 1, 2021

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).
May 25, 2016

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.
June 1, 2016

First Posted (Estimate)

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.
June 7, 2016

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.
April 25, 2022

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.
April 20, 2022

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.
February 1, 2022

More Information

Terms related to this study

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.
  • MPR-50098-UD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Restricted use files will be made available to researchers via the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan

IPD Sharing Time Frame

Mid-2022

IPD Sharing Access Criteria

Yet to be determined

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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