ParentingNCT02792309
Impact Evaluation of MotherWise Program
A study testing MotherWise Program in people with Parenting and Family Relations, run by Mathematica Policy Research, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parenting, Family Relations, Marriage
- What is being tested?
- MotherWise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 953 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible, women must be expecting a baby or had a baby in the past 3 months.
Who cannot join
- To be eligible, women must not be incarcerated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting, Family Relations, Marriage, Mother-Child Relations
- Being tested
- MotherWise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotherWise ProgramBehavioural
Healthy Marriage or Relationship Education services for pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MotherWise Program |
| Control | No intervention | No program services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived romantic relationship skills
Six-item scale (ranges from 1 to 4)
Measured: 1 year after random assignment
Perceived romantic relationship skills
Six-item scale (ranges from 1 to 4)
Measured: 30 months after random assignment
Perceived conflict management skills
Five-item scale (ranges from 1 to 4)
Measured: 1 year after random assignment
Perceived conflict management skills
Five-item scale (ranges from 1 to 4)
Measured: 30 months after random assignment
Support for going slow in romantic relationships
One-item scale (ranges from 1 to 4)
Measured: 1 year after random assignment
Support for going slow in romantic relationships
One-item scale (ranges from 1 to 4)
Measured: 30 months after random assignment
Disapproval of couple violence
Five-item scale (ranges from 1 to 4)
Measured: 1 year after random assignment
Disapproval of couple violence
Five-item scale (ranges from 1 to 4)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 months after random assignment
Quality of co-parenting relationship with baby's father
Ten-item scale (ranges from 0 to 10)
Measured: 1 year after random assignment
Quality of co-parenting relationship with baby's father
Ten-item scale (ranges from 0 to 10)
Measured: 30 months after random assignment
Depressive symptoms
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
Measured: 1 year after random assignment
Depressive symptoms
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 months after random assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 953 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Robert Wood, PhD, Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792309
- Sponsor's protocol ID
- MPR-50098-UD
- Status last verified
- Feb 2022
- First submitted
- 25 May 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 37008185
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Relationship Education and Marriage Services - Impact Evaluation of MotherWise Program
- ClinicalTrials.gov ID
- NCT02792309
- Acronym / sponsor ID
- MPR-50098-UD
- Conditions
- Parenting, Family Relations, Marriage, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 953 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Sep 2016
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MotherWise Programming | Experimental | Behavioral: MotherWise ProgramThree 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. |
| Control | No intervention | –No program services |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible, women must be expecting a baby or had a baby in the past 3 months.
Key exclusion criteria (1 listed)
- To be eligible, women must not be incarcerated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotherWise ProgramHealthy Marriage or Relationship Education services for pregnant women. | Behavioural | MotherWise Programming |
Primary outcome
Perceived romantic relationship skills
Time frame: 1 year after random assignment
Six-item scale (ranges from 1 to 4)
Perceived romantic relationship skills
Time frame: 30 months after random assignment
Six-item scale (ranges from 1 to 4)
Perceived conflict management skills
Time frame: 1 year after random assignment
Five-item scale (ranges from 1 to 4)
Perceived conflict management skills
Time frame: 30 months after random assignment
Five-item scale (ranges from 1 to 4)
Support for going slow in romantic relationships
Time frame: 1 year after random assignment
One-item scale (ranges from 1 to 4)
Support for going slow in romantic relationships
Time frame: 30 months after random assignment
One-item scale (ranges from 1 to 4)
Disapproval of couple violence
Time frame: 1 year after random assignment
Five-item scale (ranges from 1 to 4)
Disapproval of couple violence
Time frame: 30 months after random assignment
Five-item scale (ranges from 1 to 4)
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.
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.
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.
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.
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.
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.
Quality of co-parenting relationship with baby's father
Time frame: 1 year after random assignment
Ten-item scale (ranges from 0 to 10)
Quality of co-parenting relationship with baby's father
Time frame: 30 months after random assignment
Ten-item scale (ranges from 0 to 10)
Depressive symptoms
Time frame: 1 year after random assignment
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
Depressive symptoms
Time frame: 30 months after random assignment
Eight-item scale (ranges from 0 to 24; based on PHQ-8)
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 37008185Mazzoni 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wood, PhD principal investigator
Mathematica Policy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MotherWise Program in people with Parenting and Family Relations, run by Mathematica Policy Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived romantic relationship skills (time frame: 1 year after random assignment). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.