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

NCT05106361 | Completed

• 1 other identifier: 351185
• Study Type: interventional
• Target: 40
• 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 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.

Conditions

Intimate Partner Violence; Depression; Post Traumatic Stress Disorder

Keywords

Intimate partner violence; Women; Mothers; Pregnant

Outcome Measures

Primary Outcomes (5)

• 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.

  9 months

• 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.

  9 months

• Quality of Working Relationship

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

  9 months

• Reduction in depressive symptoms

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

  baseline, 3, 6 and 9 months

• Reduction in Posttraumatic Stress Disorder Symptoms

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

  baseline, 3, 6 and 9 months

Secondary Outcomes (6)

• 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 (2)

MOSAIC Plus

EXPERIMENTAL

"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.

Behavioral: MOSAIC Plus

MOSAIC

ACTIVE COMPARATOR

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.

Behavioral: MOSAIC

Interventions

MOSAIC Plus BEHAVIORAL

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.

MOSAIC Plus

MOSAIC BEHAVIORAL

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.

MOSAIC

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 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.

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; Stress Disorders, Post-Traumatic

Interventions

Mosaicism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chromosome Aberrations; Mutation; Genetic Variation; Genetic Phenomena

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: October 8, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)