ViolenceNCT05011825
A Pilot Evaluation of the Pregnant Moms' Empowerment Program
A study testing Pregnant Moms' Empowerment Program in people with Violence and Depression, run by University of Notre Dame at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Depression, Posttraumatic Stress Disorder
- What is being tested?
- Pregnant Moms' Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2017to 15 Feb 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at least 16 years of age
- experienced IPV in the past year
- currently pregnant (<33 weeks)
- English speaking
Who cannot join
- insufficient fluency in English to participate in interviews/groups
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Memphis
Memphis, Tennessee, 38152
University of NotreDame
Notre Dame, Indiana, 46556
About this study
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.
- Conditions
- Violence, Depression, Posttraumatic Stress Disorder, Parenting, Infant Development, Child Behavior
- Being tested
- Pregnant Moms' Empowerment Program
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant Moms' Empowerment ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Moms' Empowerment Program | Experimental | 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. Receives: Behavioral: Pregnant Moms' Empowerment Program |
| Control | No intervention | Control group participants received information about community resources, but did not receive any study-related intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies Depression Scale
Depression
Measured: Change from baseline assessment to post-test (5-6 weeks later)
Center for Epidemiological Studies Depression Scale
Depression
Measured: Change from baseline assessment to 3 months postpartum
Center for Epidemiological Studies Depression Scale
Depression
Measured: Change from baseline assessment to 12 months postpartum
Center for Epidemiological Studies Depression Scale
Depression
Measured: Change from baseline assessment to 3.5-5 years postpartum
PTSD Checklist - 5
Posttraumatic Stress
Measured: Change from baseline assessment to post-test (5-6 weeks later)
PTSD Checklist - 5
Posttraumatic Stress
Measured: Change from baseline assessment to 3 months postpartum
PTSD Checklist - 5
Posttraumatic Stress
Measured: Change from baseline assessment to 12 months postpartum
PTSD Checklist - 5
Posttraumatic Stress
Measured: Change from baseline assessment to 3.5-5 years postpartum
Connors Davidson Resilience Scale
Resilience
Measured: Change from baseline assessment to post-test (5-6 weeks later)
Connors Davidson Resilience Scale
Resilience
Measured: Change from baseline assessment to 3 months postpartum
Connors Davidson Resilience Scale
Resilience
Measured: Change from baseline assessment to 12 months postpartum
Connors Davidson Resilience Scale
Resilience
Measured: Change from baseline assessment to 3.5-5 years postpartum
Conflict Tactics Scales - Revised
Intimate Partner Violence
Measured: Change from baseline assessment to post-test (5-6 weeks later)
Conflict Tactics Scales - Revised
Intimate Partner Violence
Measured: Change from baseline assessment to 3 months postpartum
Conflict Tactics Scales - Revised
Intimate Partner Violence
Measured: Change from baseline assessment to 12 months postpartum
Conflict Tactics Scales - Revised
Intimate Partner Violence
Measured: Change from baseline assessment to 3.5-5 years postpartum
Adult Adolescent Parenting Inventory
Parenting Attitudes
Measured: Change from baseline assessment to post-test (5-6 weeks later)
Adult Adolescent Parenting Inventory
Parenting Attitudes
Measured: Change from baseline assessment to 3 months postpartum
Adult Adolescent Parenting Inventory
Parenting Attitudes
Measured: Change from baseline assessment to 12 months postpartum
Adult Adolescent Parenting Inventory
Parenting Attitudes
Measured: Change from baseline assessment to 3.5-5 years postpartum
Karitane Parenting Inventory
Parenting Confidence
Measured: Change from baseline assessment to post-test (5-6 weeks later)
Karitane Parenting Inventory
Parenting Confidence
Measured: Change from baseline assessment to 3 months postpartum
Karitane Parenting Inventory
Parenting Confidence
Measured: Change from baseline assessment to 12 months postpartum
Pregnancy Risk and Monitoring System (PRAMS)
Labor, Delivery and Breastfeeding
Measured: Differences between groups at 3 months postpartum
Pregnancy Risk and Monitoring System (PRAMS)
Labor, Delivery and Breastfeeding
Measured: Differences between groups at 12 months postpartum
Infant Development
Bayley Scales of Infant Development
Measured: Difference between groups at 12 months post partum
Infant Development
Bayley Scales of Infant Development
Measured: Differences between groups at 3 months postpartum
Infant Behavior Questionnaire
Infant Temperament
Measured: Differences between groups at 12 months post partum
Maternal Sensitivity and Infant Affect Regulation
Coded free play data
Measured: Differences between groups at 3 months postpartum
Maternal Sensitivity and Infant Affect Regulation
Coded free play data
Measured: Differences between groups at 12 months postpartum
Secondary outcomes (8)
Lubben Social Network Scale
Social Support
Measured: Change from baseline to posttest (5-6 weeks later)
Lubben Social Network Scale
Social Support
Measured: Change from baseline to 3 months postpartum
Lubben Social Network Scale
Social Support
Measured: Change from baseline to posttest 12 months postpartum
Lubben Social Network Scale
Social Support
Measured: Change from baseline to posttest 3.5-5 years postpartum
Rotter Locus of Control Scale
Locus of Control
Measured: Change from baseline to post-test (5-6 weeks later)
Rotter Locus of Control Scale
Locus of Control
Measured: Change from baseline to 3 months postpartum
Rotter Locus of Control Scale
Locus of Control
Measured: Change from baseline to 12 months postpartum
Child behavior checklist
Child adjustment
Measured: 3.5-5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Mar 2017
- Primary completion15 Feb 2021
- Study completion15 Feb 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 ViolenceStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011825
- Sponsor's protocol ID
- 17-08-4035
- Status last verified
- Nov 2023
- First submitted
- 2 Aug 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howell KH, Gilliam HC, Carney JR, Maloney CA, Miller-Graff LE. Long-term effects of the Pregnant Moms' Empowerment Program (PMEP) on intimate partner violence revictimization, maternal mental health, and child internalizing and externalizing problems. J Consult Clin Psychol. 2025 Sep;93(9):642-651. doi: 10.1037/ccp0000976.
PubMed 40875361
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of the Pregnant Moms' Empowerment Program
- ClinicalTrials.gov ID
- NCT05011825
- Acronym / sponsor ID
- 17-08-4035
- Conditions
- Violence, Depression, Posttraumatic Stress Disorder, Parenting, Infant Development, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- University of Memphis
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Moms' Empowerment Program | Experimental | Behavioral: Pregnant Moms' Empowerment ProgramThe 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. |
| Control | No intervention | –Control group participants received information about community resources, but did not receive any study-related intervention. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- at least 16 years of age
- experienced IPV in the past year
- currently pregnant (<33 weeks)
- English speaking
Key exclusion criteria (1 listed)
- insufficient fluency in English to participate in interviews/groups
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 |
|---|---|---|
| Pregnant Moms' Empowerment ProgramThe 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. | Behavioural | Pregnant Moms' Empowerment Program |
Primary outcome
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Depression
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline assessment to 3 months postpartum
Depression
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline assessment to 12 months postpartum
Depression
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline assessment to 3.5-5 years postpartum
Depression
PTSD Checklist - 5
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Posttraumatic Stress
PTSD Checklist - 5
Time frame: Change from baseline assessment to 3 months postpartum
Posttraumatic Stress
PTSD Checklist - 5
Time frame: Change from baseline assessment to 12 months postpartum
Posttraumatic Stress
PTSD Checklist - 5
Time frame: Change from baseline assessment to 3.5-5 years postpartum
Posttraumatic Stress
Connors Davidson Resilience Scale
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Resilience
Connors Davidson Resilience Scale
Time frame: Change from baseline assessment to 3 months postpartum
Resilience
Connors Davidson Resilience Scale
Time frame: Change from baseline assessment to 12 months postpartum
Resilience
Connors Davidson Resilience Scale
Time frame: Change from baseline assessment to 3.5-5 years postpartum
Resilience
Conflict Tactics Scales - Revised
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Intimate Partner Violence
Conflict Tactics Scales - Revised
Time frame: Change from baseline assessment to 3 months postpartum
Intimate Partner Violence
Conflict Tactics Scales - Revised
Time frame: Change from baseline assessment to 12 months postpartum
Intimate Partner Violence
Conflict Tactics Scales - Revised
Time frame: Change from baseline assessment to 3.5-5 years postpartum
Intimate Partner Violence
Adult Adolescent Parenting Inventory
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Parenting Attitudes
Adult Adolescent Parenting Inventory
Time frame: Change from baseline assessment to 3 months postpartum
Parenting Attitudes
Adult Adolescent Parenting Inventory
Time frame: Change from baseline assessment to 12 months postpartum
Parenting Attitudes
Adult Adolescent Parenting Inventory
Time frame: Change from baseline assessment to 3.5-5 years postpartum
Parenting Attitudes
Karitane Parenting Inventory
Time frame: Change from baseline assessment to post-test (5-6 weeks later)
Parenting Confidence
Karitane Parenting Inventory
Time frame: Change from baseline assessment to 3 months postpartum
Parenting Confidence
Karitane Parenting Inventory
Time frame: Change from baseline assessment to 12 months postpartum
Parenting Confidence
Pregnancy Risk and Monitoring System (PRAMS)
Time frame: Differences between groups at 3 months postpartum
Labor, Delivery and Breastfeeding
Pregnancy Risk and Monitoring System (PRAMS)
Time frame: Differences between groups at 12 months postpartum
Labor, Delivery and Breastfeeding
Infant Development
Time frame: Difference between groups at 12 months post partum
Bayley Scales of Infant Development
Infant Development
Time frame: Differences between groups at 3 months postpartum
Bayley Scales of Infant Development
Infant Behavior Questionnaire
Time frame: Differences between groups at 12 months post partum
Infant Temperament
Maternal Sensitivity and Infant Affect Regulation
Time frame: Differences between groups at 3 months postpartum
Coded free play data
Maternal Sensitivity and Infant Affect Regulation
Time frame: Differences between groups at 12 months postpartum
Coded free play data
8 secondary outcomes
Lubben Social Network Scale
Time frame: Change from baseline to posttest (5-6 weeks later)
Lubben Social Network Scale
Time frame: Change from baseline to 3 months postpartum
Lubben Social Network Scale
Time frame: Change from baseline to posttest 12 months postpartum
Lubben Social Network Scale
Time frame: 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)
Rotter Locus of Control Scale
Time frame: Change from baseline to 3 months postpartum
Rotter Locus of Control Scale
Time frame: Change from baseline to 12 months postpartum
Child behavior checklist
Time frame: 3.5-5 years postpartum
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 8 Nov 2023.
- Derived from this study: PubMed 40875361Howell KH, Gilliam HC, Carney JR, Maloney CA, Miller-Graff LE. Long-term effects of the Pregnant Moms' Empowerment Program (PMEP) on intimate partner violence revictimization, maternal mental health, and child internalizing and externalizing problems. J Consult Clin Psychol. 2025 Sep;93(9):642-651. doi: 10.1037/ccp0000976.
- Individual participant dataSharing planned: No
Related trials for Violence
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant Moms' Empowerment Program in people with Violence and Depression, run by University of Notre Dame at 2 sites 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 4 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Center for Epidemiological Studies Depression Scale (time frame: Change from baseline assessment to post-test (5-6 weeks later)). The study lists 30 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 NCT05011825, 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 8 Nov 2023.