A Pilot Evaluation of the Pregnant Moms' Empowerment Program

November 7, 2023 updated by: University of Notre Dame
This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.

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.

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.
137

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
    • Indiana
      • Notre Dame, Indiana, United States, 46556
        • University of NotreDame
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • University of Memphis

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

16 years and older (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • at least 16 years of age
  • experienced IPV in the past year
  • currently pregnant (<33 weeks)
  • English speaking

Exclusion Criteria:

  • insufficient fluency in English to participate in interviews/groups

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: Single Group Assignment
  • Masking: Single

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: Pregnant Moms' Empowerment Program
The PMEP is a 5-session program, delivered prenatally. The first three sessions address violence and mental health and the final two sessions address labor/delivery, infant health and early parenting.
Behavioral: Pregnant Moms' Empowerment Program
The first session introduces women to the group, seeks to build an alliance and sense of group cohesion, and provides safety planning. The second session addresses intergenerational patterns of violence and how such violence contributes to psychopathology in both the prenatal and postnatal period, focusing on violence prevention. Information regarding cognitive restructuring, behavioral activation, and coping styles is provided in session three, as well as the role of healthy relationships and social supports in promoting resilience. This session begins with discussion on health in pregnancy, labor/delivery, and coordinating care across providers. This session also provides psychoeducation related to post-delivery parenting, including infant safety, care and breastfeeding. In the final session, group leaders assist mothers with identification, sensitivity, and responsiveness to infant cues.
No Intervention: Control
Control group participants received information about community resources, but did not receive any study-related intervention.

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
Center for Epidemiological Studies Depression Scale
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Depression
Change from baseline assessment to post-test (5-6 weeks later)
Center for Epidemiological Studies Depression Scale
Time Frame: Change from baseline assessment to 3 months postpartum
Depression
Change from baseline assessment to 3 months postpartum
Center for Epidemiological Studies Depression Scale
Time Frame: Change from baseline assessment to 12 months postpartum
Depression
Change from baseline assessment to 12 months postpartum
Center for Epidemiological Studies Depression Scale
Time Frame: Change from baseline assessment to 3.5-5 years postpartum
Depression
Change from baseline assessment to 3.5-5 years postpartum
PTSD Checklist - 5
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Posttraumatic Stress
Change from baseline assessment to post-test (5-6 weeks later)
PTSD Checklist - 5
Time Frame: Change from baseline assessment to 3 months postpartum
Posttraumatic Stress
Change from baseline assessment to 3 months postpartum
PTSD Checklist - 5
Time Frame: Change from baseline assessment to 12 months postpartum
Posttraumatic Stress
Change from baseline assessment to 12 months postpartum
PTSD Checklist - 5
Time Frame: Change from baseline assessment to 3.5-5 years postpartum
Posttraumatic Stress
Change from baseline assessment to 3.5-5 years postpartum
Connors Davidson Resilience Scale
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Resilience
Change from baseline assessment to post-test (5-6 weeks later)
Connors Davidson Resilience Scale
Time Frame: Change from baseline assessment to 3 months postpartum
Resilience
Change from baseline assessment to 3 months postpartum
Connors Davidson Resilience Scale
Time Frame: Change from baseline assessment to 12 months postpartum
Resilience
Change from baseline assessment to 12 months postpartum
Connors Davidson Resilience Scale
Time Frame: Change from baseline assessment to 3.5-5 years postpartum
Resilience
Change from baseline assessment to 3.5-5 years postpartum
Conflict Tactics Scales - Revised
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Intimate Partner Violence
Change from baseline assessment to post-test (5-6 weeks later)
Conflict Tactics Scales - Revised
Time Frame: Change from baseline assessment to 3 months postpartum
Intimate Partner Violence
Change from baseline assessment to 3 months postpartum
Conflict Tactics Scales - Revised
Time Frame: Change from baseline assessment to 12 months postpartum
Intimate Partner Violence
Change from baseline assessment to 12 months postpartum
Conflict Tactics Scales - Revised
Time Frame: Change from baseline assessment to 3.5-5 years postpartum
Intimate Partner Violence
Change from baseline assessment to 3.5-5 years postpartum
Adult Adolescent Parenting Inventory
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Parenting Attitudes
Change from baseline assessment to post-test (5-6 weeks later)
Adult Adolescent Parenting Inventory
Time Frame: Change from baseline assessment to 3 months postpartum
Parenting Attitudes
Change from baseline assessment to 3 months postpartum
Adult Adolescent Parenting Inventory
Time Frame: Change from baseline assessment to 12 months postpartum
Parenting Attitudes
Change from baseline assessment to 12 months postpartum
Adult Adolescent Parenting Inventory
Time Frame: Change from baseline assessment to 3.5-5 years postpartum
Parenting Attitudes
Change from baseline assessment to 3.5-5 years postpartum
Karitane Parenting Inventory
Time Frame: Change from baseline assessment to post-test (5-6 weeks later)
Parenting Confidence
Change from baseline assessment to post-test (5-6 weeks later)
Karitane Parenting Inventory
Time Frame: Change from baseline assessment to 3 months postpartum
Parenting Confidence
Change from baseline assessment to 3 months postpartum
Karitane Parenting Inventory
Time Frame: Change from baseline assessment to 12 months postpartum
Parenting Confidence
Change from baseline assessment to 12 months postpartum
Pregnancy Risk and Monitoring System (PRAMS)
Time Frame: Differences between groups at 3 months postpartum
Labor, Delivery and Breastfeeding
Differences between groups at 3 months postpartum
Pregnancy Risk and Monitoring System (PRAMS)
Time Frame: Differences between groups at 12 months postpartum
Labor, Delivery and Breastfeeding
Differences between groups at 12 months postpartum
Infant Development
Time Frame: Difference between groups at 12 months post partum
Bayley Scales of Infant Development
Difference between groups at 12 months post partum
Infant Development
Time Frame: Differences between groups at 3 months postpartum
Bayley Scales of Infant Development
Differences between groups at 3 months postpartum
Infant Behavior Questionnaire
Time Frame: Differences between groups at 12 months post partum
Infant Temperament
Differences between groups at 12 months post partum
Maternal Sensitivity and Infant Affect Regulation
Time Frame: Differences between groups at 3 months postpartum
Coded free play data
Differences between groups at 3 months postpartum
Maternal Sensitivity and Infant Affect Regulation
Time Frame: Differences between groups at 12 months postpartum
Coded free play data
Differences between groups at 12 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lubben Social Network Scale
Time Frame: Change from baseline to posttest (5-6 weeks later)
Social Support
Change from baseline to posttest (5-6 weeks later)
Lubben Social Network Scale
Time Frame: Change from baseline to 3 months postpartum
Social Support
Change from baseline to 3 months postpartum
Lubben Social Network Scale
Time Frame: Change from baseline to posttest 12 months postpartum
Social Support
Change from baseline to posttest 12 months postpartum
Lubben Social Network Scale
Time Frame: Change from baseline to posttest 3.5-5 years postpartum
Social Support
Change from baseline to posttest 3.5-5 years postpartum
Rotter Locus of Control Scale
Time Frame: Change from baseline to post-test (5-6 weeks later)
Locus of Control
Change from baseline to post-test (5-6 weeks later)
Rotter Locus of Control Scale
Time Frame: Change from baseline to 3 months postpartum
Locus of Control
Change from baseline to 3 months postpartum
Rotter Locus of Control Scale
Time Frame: Change from baseline to 12 months postpartum
Locus of Control
Change from baseline to 12 months postpartum
Child behavior checklist
Time Frame: 3.5-5 years postpartum
Child adjustment
3.5-5 years postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breastfeeding Behavior Scale
Time Frame: Differences between groups at 12 months post partum
Breastfeeding attitudes
Differences between groups at 12 months post partum
Postpartum Depression Scale
Time Frame: 3 months postpartum
Postpartum depression
3 months postpartum

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.
University of Notre Dame

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.
University of Memphis

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 (Actual)

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.
March 15, 2017

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.
February 15, 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.
February 15, 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).
August 2, 2021

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.
August 13, 2021

First Posted (Actual)

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.
August 18, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
November 8, 2023

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.
November 7, 2023

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.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 17-08-4035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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