MOSAIC Plus for Domestic Violence

(MOSAIC Plus OT Trial)

Overseen By Bianca Z Alexander

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: No locator persons, No telephone, English comprehension, others

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 aims to explore a treatment called MOSAIC Plus, which supports pregnant women and mothers with young children who have experienced intimate partner violence (IPV). The goal is to determine if this treatment can reduce symptoms of depression and post-traumatic stress disorder (PTSD) and prevent further IPV. Participants should be pregnant or have children under five, have experienced IPV in the last six months, and show signs of depression or PTSD. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to better support for women facing similar challenges.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MOSAIC Plus intervention is safe for participants?

Research shows that the MOSAIC Plus program is being tested for safety and effectiveness in pregnant women and mothers who have experienced intimate partner violence (IPV). This program aims to reduce symptoms of depression and PTSD (post-traumatic stress disorder). Although detailed safety information specific to MOSAIC Plus is not yet available, similar programs typically focus on providing emotional and social support and generally pose low physical risks.

MOSAIC Plus builds on an existing program that has helped mothers dealing with IPV, indicating that it uses methods well-received in the past. As MOSAIC Plus remains in the early research phase, researchers are carefully monitoring its safety and any possible side effects.

Participants in this study can expect that new information about safety and effectiveness will refine the program before broader testing. It is important to discuss any concerns with the research team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MOSAIC Plus because it offers a novel approach to addressing domestic violence by focusing on training and recruitment methods. Unlike traditional interventions that may primarily involve legal or therapeutic solutions, MOSAIC Plus aims to refine the way we engage and support individuals through innovative techniques. This fresh perspective could lead to more effective strategies in reducing domestic violence, making it a potentially transformative tool in this challenging field.

What evidence suggests that the MOSAIC Plus intervention could be effective for reducing depressive and PTSD symptoms in women experiencing IPV?

Research has shown that the MOSAIC Plus program combines the original MOSAIC approach with principles from Interpersonal Psychotherapy (IPT). This combination aims to assist women facing intimate partner violence (IPV) who also have mental health issues like depression and PTSD (post-traumatic stress disorder). Previous studies suggest that the MOSAIC program can reduce future IPV and improve mental health for mothers. By incorporating IPT, MOSAIC Plus is expected to enhance these benefits, addressing both immediate safety and mental health needs. Although direct data on MOSAIC Plus is limited, the combined approach appears promising based on the effectiveness of each method individually. Participants in this trial will receive the MOSAIC Plus program to evaluate and refine its feasibility and acceptability. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women and mothers with children under 5 who have faced intimate partner violence (IPV) in the last 6 months. Participants must be over 18, experiencing elevated symptoms of depression or PTSD as indicated by specific questionnaires.

Inclusion Criteria

You are pregnant and/or have a child that is five years of age or younger.

You have reported experiences of intimate partner violence in the past half-year, as evaluated by the Composite Abuse Scale.

I am 18 years old or older.

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, integrating IPT principles to address IPV, depression, and PTSD symptoms

9 months

Visits at baseline, 3, 6, and 9 months

Follow-up

Participants are monitored for changes in IPV, depressive symptoms, PTSD symptoms, and other outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MOSAIC Plus

Trial Overview The MOSAIC Plus intervention is being tested to see if it can reduce symptoms of depression and PTSD while preventing further IPV. This exploratory study will help design a larger future trial and involves an integrated approach using IPT principles over a period of six months.

How Is the Trial Designed?

Group I: MOSAIC Plus Experimental Treatment 1 Intervention

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.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9116623/

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 outcomes. A ...

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

MOSAIC (MOthers' AdvocateS In the Community) for ... We will examine the acceptability of the MOSAIC Plus intervention by using data from CTQ-8 ... Mental health consequences of intimate partner ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05106361

NCT05106361 | MOSAIC (MOthers' AdvocateS In the ... The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, ...

5. researchgate.net researchgate.net/publication/26244901_MOSAIC_MOthers'_Advocates_In_the_Community_protocol_and_sample_description_of_a_cluster_randomised_trial_of_mentor_mother_support_to_reduce_intimate_partner_violence_among_pregnant_or_recent_mothers

(PDF) MOSAIC (MOthers' Advocates In the Community) There are very few studies with rigorous designs which have tested the effectiveness of IPV interventions to improve the health and wellbeing of ...

6. withpower.com withpower.com/trial/phase-1-stress-disorders-traumatic-10-2021-a4447

MOSAIC Plus for Intimate Partner Violence 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7104547/

Interventions for preventing or reducing domestic violence ... Domestic violence during pregnancy is a major public health concern. This preventable risk factor threatens both the mother and baby.

8. researchgate.net researchgate.net/figure/MOSAIC-implementation-and-timelines_fig1_50830619

MOSAIC implementation and timelines. Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV) are scarce. As much attention is focussed ...