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

NCT05968534 | Completed DMC

• 1 other identifier: 361186
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intimate Partner Violence; Depression; Posttraumatic Stress Symptom

Keywords

women; mothers; pregnant

Outcome Measures

Primary Outcomes (5)

• 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.

  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,

  9 months

• Quality of working relationship

  Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)

  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.

  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.

  baseline, 3, 6 and 9 months

Secondary Outcomes (6)

• Changes in intimate partner violence

  baseline, 3, 6 and 9 months

• Effectiveness obtaining resources

  baseline, 3, 6 and 9 months

• Perceived social support

  baseline, 3, 6 and 9 months

• Functioning

  baseline, 3, 6 and 9 months

• Self-care and self-worth

  baseline, 3, 6 and 9 months

Other Outcomes (2)

• Provider Competencies

  6 and 9 months

• Quality of working relationship-provider perspective

  3, 6 and 9 months

Study Arms (1)

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.

Behavioral: MOSAIC Plus

Interventions

MOSAIC Plus BEHAVIORAL

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.

MOSAIC Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

YWCA-Flint

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Mosaicism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Chromosome Aberrations; Mutation; Genetic Variation; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: "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.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: January 12, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)