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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02792309
Other study ID # MPR-50098-UD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2021

Study information

Verified date February 2022
Source Mathematica Policy Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 953
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MotherWise Program
Healthy Marriage or Relationship Education services for pregnant women.

Locations

Country Name City State
United States University of Denver Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
Mathematica Policy Research, Inc. Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived romantic relationship skills Six-item scale (ranges from 1 to 4) 1 year after random assignment
Primary Perceived romantic relationship skills Six-item scale (ranges from 1 to 4) 30 months after random assignment
Primary Perceived conflict management skills Five-item scale (ranges from 1 to 4) 1 year after random assignment
Primary Perceived conflict management skills Five-item scale (ranges from 1 to 4) 30 months after random assignment
Primary Support for going slow in romantic relationships One-item scale (ranges from 1 to 4) 1 year after random assignment
Primary Support for going slow in romantic relationships One-item scale (ranges from 1 to 4) 30 months after random assignment
Primary Disapproval of couple violence Five-item scale (ranges from 1 to 4) 1 year after random assignment
Primary Disapproval of couple violence Five-item scale (ranges from 1 to 4) 30 months after random assignment
Primary Any psychological abuse 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
Primary Any psychological abuse 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
Primary Any physical abuse 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
Primary Any physical abuse 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
Primary Had an unintended pregnancy since program enrollment A binary variable equal to 1 if the mother reported having had an unintended pregnancy since random assignment. 1 year after random assignment
Primary Had an unintended pregnancy since program enrollment A binary variable equal to 1 if the mother reported having had an unintended pregnancy since random assignment. 30 months after random assignment
Primary Quality of co-parenting relationship with baby's father Ten-item scale (ranges from 0 to 10) 1 year after random assignment
Primary Quality of co-parenting relationship with baby's father Ten-item scale (ranges from 0 to 10) 30 months after random assignment
Primary Depressive symptoms Eight-item scale (ranges from 0 to 24; based on PHQ-8) 1 year after random assignment
Primary Depressive symptoms Eight-item scale (ranges from 0 to 24; based on PHQ-8) 30 months after random assignment
Primary Number of relationship transitions 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
Primary Material hardship 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
Primary Child social-emotional and behavioral problems 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
Primary Child social-emotional abilities 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
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