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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 (MOSAIC Plus OT)

Primary Purpose

Intimate Partner Violence, Depression, Posttraumatic Stress Symptom

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MOSAIC Plus
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intimate Partner Violence focused on measuring women, mothers, pregnant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    MOSAIC Plus

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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,
    Quality of working relationship
    Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)
    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.
    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.

    Secondary Outcome Measures

    Changes in intimate partner violence
    Number of participants reporting changes in subsequent intimate partner violence by using Composite Abuse Scale. Higher scores indicate severity of intimate partner violence.
    Effectiveness obtaining resources
    Number of participants reporting changes in effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale. Higher scores indicate improved effectiveness in obtaining resources.
    Perceived social support
    Number of participants reporting changes in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS). Higher scores demonstrate strength of social support.
    Functioning
    Number of participants reporting changes in mental health related disability as evaluated by WHO Disability Assessment schedule-12. Higher scores demonstrate severity of mental health related disability.
    Self-care and self-worth
    Number of participants reporting changes in self-care and self-worth as evaluated by self-care and self-worth scale.
    General health and wellbeing
    Number of participants reporting changes in general health and wellbeing as evaluated by the SF-36 scale. Scale ranges 0-100 and higher scores indicate better health and wellbeing.

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    July 31, 2023
    Sponsor
    Michigan State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05968534
    Brief Title
    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
    Acronym
    MOSAIC Plus OT
    Official Title
    MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Open Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 31, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    April 14, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Michigan State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Violence against women is a global human rights concern and a significant public health challenge; 1 in 3 three women experience lifetime physical and/or sexual violence. As many as 5.3 million U.S. women report experiencing intimate partner violence (IPV; referring to sexual or physical violence by current or former partners) annually. Depression and posttraumatic stress disorder (PTSD) are the two most common mental health consequences of IPV. In turn, developing depressive and PTSD symptoms after experiencing IPV increases future risk of IPV3. IPV is also associated with chronic physical health problems and self-harm . Motherhood and pregnancy increase the risk for prolonged exposure to physical, psychological and sexual IPV. With as many as 4% to 8% of pregnant women reporting IPV during pregnancy, IPV can start or worsen during the perinatal period. Previous and current experience of IPV is strongly associated with poor physical health, mental health and obstetric outcomes; leading to increased utilization of health services11 even after the IPV ends12. There are very few interventions that effectively reduce IPV among pregnant women and mothers with children under 5 who report IPV. One of them, Mother AdvocateS In the Community (MOSAIC) forms the basis of this proposal16. No existing intervention addresses the depressive and PTSD symptoms that often follow IPV, are associated with suffering and morbidity, and potentiate future IPV risk for pregnant women and mothers with children under 5 who report IPV. In fact, there are not any interventions for any group of women that effectively reduce both future IPV risk and common related mental health symptoms such as depression and PTSD. An integrated intervention that addresses elevated symptoms of maternal depression and PTSD while reducing subsequent IPV is needed. MOSAIC is a non-professional intervention delivered by mentor mothers from the community to reduce IPV in pregnant women and mothers with children under 5. The intervention combines elements of mentoring and IPV-specific support provided by mentor mothers. MOSAIC was also tested in a fully-powered RCT for pregnant women and mothers with children under 5 in Australia and found to reduce subsequent IPV. However, it did not significantly improve depression, and PTSD symptoms were not evaluated. Given the suffering, morbidity, and additional risk of IPV conferred by depressive and PTSD symptoms, the proposed study will augment MOSAIC with principles of an evidence-based intervention to improve maternal mental health. Interpersonal psychotherapy (IPT) is the front-line treatment for maternal depression18 and has been found to reduce PTSD symptoms in the perinatal period19. IPT addresses maternal mental health by helping women increase their general social support systems and build communication skills and confidence to access needed resources and help. IPT can be effectively delivered by lay providers. This proposal will integrate IPT principles into MOSAIC to address both IPV and its mental health sequelae. 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 9 months after enrollment. Women will be recruited from Obstetrics and Gynecological unit of the Hurley Medical Center and YWCA, Flint. The control condition will be the original MOSAIC intervention. Study assessments will take place at baseline, 3, 6 and 9 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intimate Partner Violence, Depression, Posttraumatic Stress Symptom
    Keywords
    women, mothers, pregnant

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    "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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MOSAIC Plus
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    MOSAIC Plus
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Acceptability
    Description
    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.
    Time Frame
    9 months
    Title
    Satisfaction with care
    Description
    Number of clients reporting satisfaction with care through rate of recruitment, client retention and intervention completion as reported in the Client Satisfaction Questionnaire,
    Time Frame
    9 months
    Title
    Quality of working relationship
    Description
    Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)
    Time Frame
    9 months
    Title
    Changes in depressive symptoms
    Description
    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.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    Changes in posttraumatic stress disorder symptoms
    Description
    Number of participants reporting changes in posttraumatic stress disorder symptoms by using Davidson Trauma Scale. Higher scores indicate severity of posttraumatic stress symptoms.
    Time Frame
    baseline, 3, 6 and 9 months
    Secondary Outcome Measure Information:
    Title
    Changes in intimate partner violence
    Description
    Number of participants reporting changes in subsequent intimate partner violence by using Composite Abuse Scale. Higher scores indicate severity of intimate partner violence.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    Effectiveness obtaining resources
    Description
    Number of participants reporting changes in effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale. Higher scores indicate improved effectiveness in obtaining resources.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    Perceived social support
    Description
    Number of participants reporting changes in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS). Higher scores demonstrate strength of social support.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    Functioning
    Description
    Number of participants reporting changes in mental health related disability as evaluated by WHO Disability Assessment schedule-12. Higher scores demonstrate severity of mental health related disability.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    Self-care and self-worth
    Description
    Number of participants reporting changes in self-care and self-worth as evaluated by self-care and self-worth scale.
    Time Frame
    baseline, 3, 6 and 9 months
    Title
    General health and wellbeing
    Description
    Number of participants reporting changes in general health and wellbeing as evaluated by the SF-36 scale. Scale ranges 0-100 and higher scores indicate better health and wellbeing.
    Time Frame
    baseline, 3, 6 and 9 months
    Other Pre-specified Outcome Measures:
    Title
    Provider Competencies
    Description
    Number of participants reporting on competency of providers by using Competency Assessment Inventory (CAI).
    Time Frame
    6 and 9 months
    Title
    Quality of working relationship-provider perspective
    Description
    Assess the quality of working relationship by using the provider perspective section of working alliance inventory. The scale has scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.
    Time Frame
    3, 6 and 9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maji Debena, PhD
    Phone
    810-600-5684
    Email
    debenama@msu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bianca Z Alexander
    Email
    donaldbi@msu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    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

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