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

40 Participants Needed

Trial Summary

What is the purpose of this 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.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+