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Intimate Partner ViolenceMOSAIC PlusNCT05106361

MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence

A study testing MOSAIC Plus and MOSAIC in people with Intimate Partner Violence and Depression, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
MOSAIC Plus and MOSAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
8 Oct 2024to 27 Feb 2026
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 and r
  • 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.

United States1 site
  • YWCA Flint

    Flint, Michigan, 48502

Other trials in United States

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: Randomized 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 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 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.1 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) annually2. 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 problems4,5 and self-harm 6.

Motherhood and pregnancy increase the risk for prolonged exposure to physical, psychological and sexual IPV7. With as many as 4% to 8% of pregnant women reporting IPV during pregnancy, IPV can start or worsen during the perinatal period8. Previous and current experience of IPV is strongly associated with poor physical health, mental health and obstetric outcomes9,10; 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 IPV13-15. 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 517. 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 IPV15. 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.

The development aims of this proposal are to:

  1. Enhance and expand the MOSAIC manual (designed to be delivered by lay providers) with lay-provider friendly IPT principles for reducing depressive and PTSD symptoms.
  2. Refine the manual, intervention, and study procedures using 6 focus groups: 3 groups with mothers who have experienced IPV in the past 6 months (n~20), 2 with potential mentor mothers (n~16), and 1 group with nurse-family partnership staff (n~8)
  3. Develop, implement, and evaluate the intervention training program.
  4. Improve the clarity, content, acceptability, and feasibility of the enhanced MOSAIC Plus intervention through a small open trial (n = 15) of mothers with past 6-month IPV experience The pilot study aims of this proposal are to:
  5. Conduct a pilot RCT in a sample of 40 mothers with IPV experience in the past 6 months to demonstrate the feasibility and acceptability of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions. As recommended by NIMH, we will also examine 95% confidence intervals around differences between the proposed intervention and MOSAIC for the following outcomes through 9 months after baseline:
  6. Mental health outcomes. Reduction in depressive (primary) and PTSD symptoms
  7. IPV outcomes. Decreased subsequent IPV over the 9 months measured by CAS
  8. Functioning outcomes. Improvement in functioning, self-care and general health and wellbeing
  9. Potential target mechanisms. Increased social support and effectiveness obtaining resources.

Interventions to improve mental health challenges experienced by mothers who experienced IPV are of great public health significance. Reducing depressive and PTSD symptoms in women with the experience of IPV has significant public health benefits for mothers and their children.

Being tested
MOSAIC Plus, MOSAIC
Keywords
Intimate partner violence, Women, Mothers, Pregnant
Medical subject headings
Depression, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOSAIC PlusBehavioural

    Those in the experimental arm 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.

  • MOSAICBehavioural

    Those in the active comparator will receive a mentor mother intervention named Mother AdvocateS In the Community (MOSAIC). This does not include the IPT component.

Study groups in NCT05106361
Study groupRoleWhat they receive
MOSAIC PlusExperimental"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.
Receives: Behavioral: MOSAIC Plus
MOSAICActive comparatorThose in the active comparator will receive 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.
Receives: Behavioral: MOSAIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acceptability

    We will evaluate the 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.

    Measured: 9 months

  2. Satisfaction with care

    We will evaluate the feasibility of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions by using Client Satisfaction Questionnaire.

    Measured: 9 months

  3. Quality of Working Relationship

    We will evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)

    Measured: 9 months

  4. Reduction in depressive symptoms

    We will measure reduction in depressive symptoms as assessed by Patient Health Questionnaire (PHQ-9).

    Measured: baseline, 3, 6 and 9 months

  5. Reduction in Posttraumatic Stress Disorder Symptoms

    We will measure reduction in posttraumatic stress disorder symptoms by using Davidson Trauma Scale.

    Measured: baseline, 3, 6 and 9 months

Secondary outcomes (6)
  1. Intimate Partner Violence

    We will measure reduction in subsequent intimate partner violence by using Composite Abuse Scale.

    Measured: baseline, 3, 6 and 9 months

  2. Effectiveness Obtaining Resources

    We will measure effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale.

    Measured: baseline, 3, 6 and 9 months

  3. Perceived Social Support

    We will measure improvements in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS)

    Measured: baseline, 3, 6 and 9 months

  4. Functioning

    We will use the WHO Disability Assessment schedule-12 to assess mental health related disability.

    Measured: baseline, 3, 6 and 9 months

  5. Self-care and self-worth

    We will use the self-care and self-worth scale to assess changes in self-care.

    Measured: baseline, 3, 6 and 9 months

  6. General health and wellbeing

    We will use the SF-36 to assess changes in general 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.

  1. First posted3 Nov 2021
  2. Study start8 Oct 2024
  3. Primary completion27 Feb 2026
  4. Study completion27 Feb 2026

Resources

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
Model description
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. Those in the intervention arm will receive MOSAIC Plus (an enhanced MOSAIC intervention that includes IPT) while those in the active control would receive MOSAIC intervention.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05106361
Sponsor's protocol ID
351185
Acronym
MOSAIC Plus
Status last verified
May 2026
First submitted
22 Oct 2021
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MOSAIC Plus and MOSAIC 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 22 May 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 22 May 2026.

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