NCT02792309

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
953

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 25, 2022

Status Verified

February 1, 2022

Enrollment Period

5 years

First QC Date

May 25, 2016

Last Update Submit

April 20, 2022

Conditions

ParentingFamily RelationsMarriageMother-Child Relations

Outcome Measures

Primary Outcomes (22)

  • Perceived romantic relationship skills

    Six-item scale (ranges from 1 to 4)

    1 year after random assignment

  • Perceived romantic relationship skills

    Six-item scale (ranges from 1 to 4)

    30 months after random assignment

  • Perceived conflict management skills

    Five-item scale (ranges from 1 to 4)

    1 year after random assignment

  • Perceived conflict management skills

    Five-item scale (ranges from 1 to 4)

    30 months after random assignment

  • Support for going slow in romantic relationships

    One-item scale (ranges from 1 to 4)

    1 year after random assignment

  • Support for going slow in romantic relationships

    One-item scale (ranges from 1 to 4)

    30 months after random assignment

  • Disapproval of couple violence

    Five-item scale (ranges from 1 to 4)

    1 year after random assignment

  • Disapproval of couple violence

    Five-item scale (ranges from 1 to 4)

    30 months after random assignment

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Quality of co-parenting relationship with baby's father

    Ten-item scale (ranges from 0 to 10)

    1 year after random assignment

  • Quality of co-parenting relationship with baby's father

    Ten-item scale (ranges from 0 to 10)

    30 months after random assignment

  • Depressive symptoms

    Eight-item scale (ranges from 0 to 24; based on PHQ-8)

    1 year after random assignment

  • Depressive symptoms

    Eight-item scale (ranges from 0 to 24; based on PHQ-8)

    30 months after random assignment

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

MotherWise Programming

EXPERIMENTAL

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

Control

NO INTERVENTION

No program services

Interventions

MotherWise ProgramBEHAVIORAL

Healthy Marriage or Relationship Education services for pregnant women.

MotherWise Programming

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • To be eligible, women must not be incarcerated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Denver

Denver, Colorado, 80208, United States

Location

Related Publications (1)

  • Mazzoni SE, O'Reilly Treter M, Hyer J, Pena R, Rhoades GK. Impact of Prenatal Group Healthy Relationship Education on Postpartum Contraception. Womens Health Rep (New Rochelle). 2023 Mar 27;4(1):148-153. doi: 10.1089/whr.2022.0104. eCollection 2023.

    PMID: 37008185DERIVED

Study Officials

  • Robert Wood, PhD

    Mathematica Policy Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 7, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

April 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

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

Time Frame
Mid-2022
Access Criteria
Yet to be determined

Locations

US(1)