- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792309
Impact Evaluation of MotherWise Program
Strengthening Relationship Education and Marriage Services - Impact Evaluation of MotherWise Program
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80208
- University of Denver
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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: 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.
|
Healthy Marriage or Relationship Education services for pregnant women.
|
No Intervention: Control
No program services
|
What is the study measuring?
Primary Outcome Measures
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
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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
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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
Collaborators
Investigators
- Principal Investigator: Robert Wood, PhD, Mathematica Policy Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MPR-50098-UD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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