CompletedNot Applicable

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

United States15 participantsStarted 2024-01-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Acceptability

Timeframe: 9 months

Satisfaction with care

Timeframe: 9 months

Quality of working relationship

Timeframe: 9 months

Changes in depressive symptoms

Timeframe: baseline, 3, 6 and 9 months

Changes in posttraumatic stress disorder symptoms

Timeframe: baseline, 3, 6 and 9 months

Trial details

NCT IDNCT05968534

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Intimate Partner Violence trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.