MOSAIC Plus for Intimate Partner Violence

(MOSAIC Plus Trial)

Overseen By Maji H Debena, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: No locator contacts, No phone, English comprehension

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to support pregnant women and mothers of young children who have experienced intimate partner violence (IPV) and are dealing with depression or PTSD (post-traumatic stress disorder). The study tests a program called "MOSAIC Plus," which incorporates skills from interpersonal therapy to better address the mental health impact of IPV. Participants will be divided into two groups: one will receive the original MOSAIC program, while the other will try the enhanced MOSAIC Plus version. This trial suits pregnant women or mothers with children under five who have experienced IPV in the last six months and feel depressed or stressed. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance mental health support for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the MOSAIC Plus intervention is safe for pregnant women and mothers with children under 5?

Research has shown that the MOSAIC Plus program builds on the existing MOSAIC program, which has helped women facing intimate partner violence (IPV). Although specific data on MOSAIC Plus is limited, the original MOSAIC program has been proven to reduce symptoms of depression and PTSD in women who have experienced IPV.

No major safety concerns have been reported with the MOSAIC program. Since MOSAIC Plus adds more principles to it, MOSAIC Plus is likely to be safe as well. This program focuses on providing support and skills to manage the effects of IPV, rather than using medication or invasive procedures, so the risk of physical side effects remains low.

Participants should discuss any concerns with the trial team to ensure they feel comfortable and informed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOSAIC Plus intervention for addressing Intimate Partner Violence (IPV) because it integrates Interpersonal Psychotherapy (IPT) principles into an existing community-based program. Unlike traditional therapy options that often focus solely on mental health issues like depression and PTSD, MOSAIC Plus takes a comprehensive approach by also aiming to prevent future instances of IPV. This dual focus on mental health and prevention makes it a unique and promising option for pregnant women and mothers with young children who are experiencing IPV.

What evidence suggests that this trial's treatments could be effective for reducing depressive and PTSD symptoms in women experiencing IPV?

Research has shown that the MOSAIC Plus program, which incorporates concepts from Interpersonal Psychotherapy (IPT), may assist women facing intimate partner violence (IPV). In this trial, participants will receive either the MOSAIC or MOSAIC Plus intervention. Studies have found that similar programs can reduce symptoms of depression and PTSD in these women. MOSAIC Plus aims to not only decrease future IPV incidents but also improve mental health issues like depression and PTSD in mothers. Early results suggest that combining community support with therapy creates a supportive environment for mothers, potentially enhancing emotional health. While researchers continue to collect data, this approach addresses critical issues for women experiencing IPV. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women or mothers with children under 5 who have faced intimate partner violence (IPV) in the last 6 months and are showing signs of depression or PTSD. Participants must be over 18, able to provide contact info for two people who can locate them, and understand English well enough for consent and assessments.

Inclusion Criteria

I have significant depression or PTSD symptoms.

Pregnant and/or are mothers of children under 5 and report IPV experiences in the past 6 months (as assessed by Composite Abuse Scale)

Exclusion Criteria

Cannot understand English well enough to understand the consent form or assessment instruments when they are read aloud

Do not have access to any telephone

Cannot provide the name and contact information of at least two locator persons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MOSAIC Plus intervention to reduce depressive and PTSD symptoms and prevent additional IPV.

9 months

Visits at baseline, 3, 6, and 9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MOSAIC
• MOSAIC Plus

Trial Overview The MOSAIC Plus intervention is being tested to see if it helps reduce symptoms of depression and PTSD while preventing further IPV. It combines interpersonal therapy techniques with the existing MOSAIC support program over a period of six months after joining the study.

How Is the Trial Designed?

Group I: MOSAIC Plus Experimental Treatment 1 Intervention

"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.

Group II: MOSAIC Active Control 1 Intervention

Those 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.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05968534

MOSAIC (MOthers' AdvocateS In the Community) for ... The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35584181/

MOSAIC (MOthers' AdvocateS In the Community) for pregnant ... This study will develop MOthers' AdvocateS In the Community (MOSAIC) Plus intervention for pregnant women and mothers with children under the age of 5.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0267679

MOSAIC (MOthers' AdvocateS In the Community) for pregnant ... This study aims to develop an intervention that reduces future intimate partner violence, while also addressing related maternal mental health outcomes. A ...

4. medrxiv.org medrxiv.org/content/10.1101/2022.04.14.22273885v1

A pilot randomized trial study protocol This study aims to develop an intervention that reduces future intimate partner violence, while also addressing related maternal mental health ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cl2.1423

Interventions for intimate partner violence during the ... This scoping review is designed to broadly capture all potential interventions for perinatal IPV and describe their core components and measured outcomes.

6. medrxiv.org medrxiv.org/content/10.1101/2022.04.14.22273885v1.full.pdf

MOSAIC (MOthers' AdvocateS In the Community) for ... Evaluate changes in symptoms of depression and PTSD. 16. 3. Assess reduction in subsequent IPV. 17. 4. Measure changes ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-022-04400-z

Safe Pregnancy intervention for intimate partner violence: a ... Intimate partner violence (IPV) during pregnancy is a global health problem with adverse consequences for mothers, infants and families.