Intimate Partner ViolenceMOSAIC Plus OTNCT05968534
MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence (MOSAIC Plus) Open Trial
A study testing MOSAIC Plus in people with Intimate Partner Violence and Depression, run by Michigan State University at 1 site in United States.
Trial summary
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intimate Partner Violence, Depression, Posttraumatic Stress Symptom
- What is being tested?
- MOSAIC Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 30 Apr 2025
- 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
- Pregnant and/or are mothers of children under 5
- Report IPV experiences in the past 6 months (as assessed by Composite Abuse Scale)
- Aged 18 or above,
- Have elevated depressive and/or PTSD symptoms as assessed by Patient Health Questionnaire (PHQ-9) with a cutoff point of ≥9, and/or the Davidson Trauma Scale (DTS) with a cut-off point of ≥40.
Who cannot join
- Cannot provide the name and contact information of at least two locator persons,
- Do not have access to any telephone,
- Cannot understand English well enough to understand the consent form or assessment instruments when they are read aloud
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Open Trial
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed open trial will enroll 15 pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.
Read the detailed description
Violence against women is a global human rights concern and a significant public health challenge; 1 in 3 three women experience lifetime physical and/or sexual violence. As many as 5.3 million U.S. women report experiencing intimate partner violence (IPV; referring to sexual or physical violence by current or former partners) annually. Depression and posttraumatic stress disorder (PTSD) are the two most common mental health consequences of IPV. In turn, developing depressive and PTSD symptoms after experiencing IPV increases future risk of IPV3. IPV is also associated with chronic physical health problems and self-harm .
Motherhood and pregnancy increase the risk for prolonged exposure to physical, psychological and sexual IPV. With as many as 4% to 8% of pregnant women reporting IPV during pregnancy, IPV can start or worsen during the perinatal period. Previous and current experience of IPV is strongly associated with poor physical health, mental health and obstetric outcomes; leading to increased utilization of health services11 even after the IPV ends12. There are very few interventions that effectively reduce IPV among pregnant women and mothers with children under 5 who report IPV. One of them, Mother AdvocateS In the Community (MOSAIC) forms the basis of this proposal16. No existing intervention addresses the depressive and PTSD symptoms that often follow IPV, are associated with suffering and morbidity, and potentiate future IPV risk for pregnant women and mothers with children under 5 who report IPV. In fact, there are not any interventions for any group of women that effectively reduce both future IPV risk and common related mental health symptoms such as depression and PTSD. An integrated intervention that addresses elevated symptoms of maternal depression and PTSD while reducing subsequent IPV is needed.
MOSAIC is a non-professional intervention delivered by mentor mothers from the community to reduce IPV in pregnant women and mothers with children under 5. The intervention combines elements of mentoring and IPV-specific support provided by mentor mothers. MOSAIC was also tested in a fully-powered RCT for pregnant women and mothers with children under 5 in Australia and found to reduce subsequent IPV. However, it did not significantly improve depression, and PTSD symptoms were not evaluated. Given the suffering, morbidity, and additional risk of IPV conferred by depressive and PTSD symptoms, the proposed study will augment MOSAIC with principles of an evidence-based intervention to improve maternal mental health. Interpersonal psychotherapy (IPT) is the front-line treatment for maternal depression18 and has been found to reduce PTSD symptoms in the perinatal period19. IPT addresses maternal mental health by helping women increase their general social support systems and build communication skills and confidence to access needed resources and help. IPT can be effectively delivered by lay providers. This proposal will integrate IPT principles into MOSAIC to address both IPV and its mental health sequelae.
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 9 months after enrollment. Women will be recruited from Obstetrics and Gynecological unit of the Hurley Medical Center and YWCA, Flint. The control condition will be the original MOSAIC intervention. Study assessments will take place at baseline, 3, 6 and 9 months.
- Being tested
- MOSAIC Plus
- Keywords
- women, mothers, pregnant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSAIC PlusBehavioural
This is a single-arm study. Participants will receive the intervention is called "Mother AdvocateS In the Community (MOSAIC) Plus", an intervention to reduce depressive and PTSD symptoms and prevent additional intimate partner violence among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate interpersonal psychotherapy principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| MOSAIC Plus | Other | This is a single-arm open-trial to evaluate and refine the feasibility and acceptability of training and recruitment methods. Data from this phase will be used to refine and inform study procedures for the subsequent RCT. Receives: Behavioral: MOSAIC Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Number of clients reporting acceptability of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions by using End of Treatment Questionnaire. The questionnaire assesses rate of recruitment and retention of participants and dropouts and rates of completion.
Measured: 9 months
Satisfaction with care
Number of clients reporting satisfaction with care through rate of recruitment, client retention and intervention completion as reported in the Client Satisfaction Questionnaire,
Measured: 9 months
Quality of working relationship
Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)
Measured: 9 months
Changes in depressive symptoms
Number of participants reporting changes in depressive symptoms as assessed by Patient Health Questionnaire (PHQ-9). Scores range from 0-27. Higher scores indicate severity of depressive symptoms.
Measured: baseline, 3, 6 and 9 months
Changes in posttraumatic stress disorder symptoms
Number of participants reporting changes in posttraumatic stress disorder symptoms by using Davidson Trauma Scale. Higher scores indicate severity of posttraumatic stress symptoms.
Measured: baseline, 3, 6 and 9 months
Secondary outcomes (6)
Changes in intimate partner violence
Number of participants reporting changes in subsequent intimate partner violence by using Composite Abuse Scale. Higher scores indicate severity of intimate partner violence.
Measured: baseline, 3, 6 and 9 months
Effectiveness obtaining resources
Number of participants reporting changes in effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale. Higher scores indicate improved effectiveness in obtaining resources.
Measured: baseline, 3, 6 and 9 months
Perceived social support
Number of participants reporting changes in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS). Higher scores demonstrate strength of social support.
Measured: baseline, 3, 6 and 9 months
Functioning
Number of participants reporting changes in mental health related disability as evaluated by WHO Disability Assessment schedule-12. Higher scores demonstrate severity of mental health related disability.
Measured: baseline, 3, 6 and 9 months
Self-care and self-worth
Number of participants reporting changes in self-care and self-worth as evaluated by self-care and self-worth scale.
Measured: baseline, 3, 6 and 9 months
General health and wellbeing
Number of participants reporting changes in general health and wellbeing as evaluated by the SF-36 scale. Scale ranges 0-100 and higher scores indicate better health and wellbeing.
Measured: baseline, 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start12 Jan 2024
- Primary completion31 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maji Debena, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968534
- Sponsor's protocol ID
- 361186
- Acronym
- MOSAIC Plus OT
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Open Trial
- ClinicalTrials.gov ID
- NCT05968534
- Acronym / sponsor ID
- MOSAIC Plus OT / 361186
- Keywords
- women, mothers, pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 1 Aug 2023 (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.
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed open trial will enroll 15 pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.
Detailed description
Violence against women is a global human rights concern and a significant public health challenge; 1 in 3 three women experience lifetime physical and/or sexual violence. As many as 5.3 million U.S. women report experiencing intimate partner violence (IPV; referring to sexual or physical violence by current or former partners) annually. Depression and posttraumatic stress disorder (PTSD) are the two most common mental health consequences of IPV. In turn, developing depressive and PTSD symptoms after experiencing IPV increases future risk of IPV3. IPV is also associated with chronic physical health problems and self-harm .
Motherhood and pregnancy increase the risk for prolonged exposure to physical, psychological and sexual IPV. With as many as 4% to 8% of pregnant women reporting IPV during pregnancy, IPV can start or worsen during the perinatal period. Previous and current experience of IPV is strongly associated with poor physical health, mental health and obstetric outcomes; leading to increased utilization of health services11 even after the IPV ends12. There are very few interventions that effectively reduce IPV among pregnant women and mothers with children under 5 who report IPV. One of them, Mother AdvocateS In the Community (MOSAIC) forms the basis of this proposal16. No existing intervention addresses the depressive and PTSD symptoms that often follow IPV, are associated with suffering and morbidity, and potentiate future IPV risk for pregnant women and mothers with children under 5 who report IPV. In fact, there are not any interventions for any group of women that effectively reduce both future IPV risk and common related mental health symptoms such as depression and PTSD. An integrated intervention that addresses elevated symptoms of maternal depression and PTSD while reducing subsequent IPV is needed.
MOSAIC is a non-professional intervention delivered by mentor mothers from the community to reduce IPV in pregnant women and mothers with children under 5. The intervention combines elements of mentoring and IPV-specific support provided by mentor mothers. MOSAIC was also tested in a fully-powered RCT for pregnant women and mothers with children under 5 in Australia and found to reduce subsequent IPV. However, it did not significantly improve depression, and PTSD symptoms were not evaluated. Given the suffering, morbidity, and additional risk of IPV conferred by depressive and PTSD symptoms, the proposed study will augment MOSAIC with principles of an evidence-based intervention to improve maternal mental health. Interpersonal psychotherapy (IPT) is the front-line treatment for maternal depression18 and has been found to reduce PTSD symptoms in the perinatal period19. IPT addresses maternal mental health by helping women increase their general social support systems and build communication skills and confidence to access needed resources and help. IPT can be effectively delivered by lay providers. This proposal will integrate IPT principles into MOSAIC to address both IPV and its mental health sequelae.
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 9 months after enrollment. Women will be recruited from Obstetrics and Gynecological unit of the Hurley Medical Center and YWCA, Flint. The control condition will be the original MOSAIC intervention. Study assessments will take place at baseline, 3, 6 and 9 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms.
| Arm | Type | Receives |
|---|---|---|
| MOSAIC Plus | Other | Behavioral: MOSAIC PlusThis is a single-arm open-trial to evaluate and refine the feasibility and acceptability of training and recruitment methods. Data from this phase will be used to refine and inform study procedures for the subsequent RCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant and/or are mothers of children under 5
- Report IPV experiences in the past 6 months (as assessed by Composite Abuse Scale)
- Aged 18 or above,
- Have elevated depressive and/or PTSD symptoms as assessed by Patient Health Questionnaire (PHQ-9) with a cutoff point of ≥9, and/or the Davidson Trauma Scale (DTS) with a cut-off point of ≥40.
Key exclusion criteria (3 listed)
- Cannot provide the name and contact information of at least two locator persons,
- Do not have access to any telephone,
- Cannot understand English well enough to understand the consent form or assessment instruments when they are read aloud
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 |
|---|---|---|
| MOSAIC PlusThis is a single-arm study. Participants will receive the intervention is called "Mother AdvocateS In the Community (MOSAIC) Plus", an intervention to reduce depressive and PTSD symptoms and prevent additional intimate partner violence among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate interpersonal psychotherapy principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. | Behavioural | MOSAIC Plus |
Primary outcome
Acceptability
Time frame: 9 months
Number of clients reporting acceptability of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions by using End of Treatment Questionnaire. The questionnaire assesses rate of recruitment and retention of participants and dropouts and rates of completion.
Satisfaction with care
Time frame: 9 months
Number of clients reporting satisfaction with care through rate of recruitment, client retention and intervention completion as reported in the Client Satisfaction Questionnaire,
Quality of working relationship
Time frame: 9 months
Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)
Changes in depressive symptoms
Time frame: baseline, 3, 6 and 9 months
Number of participants reporting changes in depressive symptoms as assessed by Patient Health Questionnaire (PHQ-9). Scores range from 0-27. Higher scores indicate severity of depressive symptoms.
Changes in posttraumatic stress disorder symptoms
Time frame: baseline, 3, 6 and 9 months
Number of participants reporting changes in posttraumatic stress disorder symptoms by using Davidson Trauma Scale. Higher scores indicate severity of posttraumatic stress symptoms.
6 secondary outcomes
Changes in intimate partner violence
Time frame: baseline, 3, 6 and 9 months
Effectiveness obtaining resources
Time frame: baseline, 3, 6 and 9 months
Perceived social support
Time frame: baseline, 3, 6 and 9 months
Functioning
Time frame: baseline, 3, 6 and 9 months
Self-care and self-worth
Time frame: baseline, 3, 6 and 9 months
General health and wellbeing
Time frame: baseline, 3, 6 and 9 months
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 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Intimate Partner Violence
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOSAIC Plus in people with Intimate Partner Violence and Depression, run by Michigan State University 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 4 inclusion and 3 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 29 Jan 2026. 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?
Acceptability (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.