YWCA Flint
Flint, Michigan, 48502, United States
NCT Number: NCT05106361
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Flint, Michigan, 48502, United States
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.1 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) annually2. 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 problems4,5 and self-harm 6.
Motherhood and pregnancy increase the risk for prolonged exposure to physical, psychological and sexual IPV7. With as many as 4% to 8% of pregnant women reporting IPV during pregnancy, IPV can start or worsen during the perinatal period8. Previous and current experience of IPV is strongly associated with poor physical health, mental health and obstetric outcomes9,10; 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 IPV13-15. 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 517. 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 IPV15. 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.
The development aims of this proposal are to:
The pilot study aims of this proposal are to:
Interventions to improve mental health challenges experienced by mothers who experienced IPV are of great public health significance. Reducing depressive and PTSD symptoms in women with the experience of IPV has significant public health benefits for mothers and their children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
We will evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR)
Time frame: baseline, 3, 6 and 9 months
We will measure reduction in depressive symptoms as assessed by Patient Health Questionnaire (PHQ-9).
Time frame: baseline, 3, 6 and 9 months
We will measure reduction in posttraumatic stress disorder symptoms by using Davidson Trauma Scale.
Time frame: baseline, 3, 6 and 9 months
We will measure reduction in subsequent intimate partner violence by using Composite Abuse Scale.
Time frame: baseline, 3, 6 and 9 months
We will measure effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale.
Time frame: baseline, 3, 6 and 9 months
We will measure improvements in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS)
Time frame: baseline, 3, 6 and 9 months
We will use the WHO Disability Assessment schedule-12 to assess mental health related disability.
Time frame: baseline, 3, 6 and 9 months
We will use the self-care and self-worth scale to assess changes in self-care.
Time frame: baseline, 3, 6 and 9 months
We will use the SF-36 to assess changes in general health and wellbeing.
Time frame: 6 and 9 months
We will assess competency of providers by using Competency Assessment Inventory (CAI)
Time frame: 3, 6 and 9 months
We will assess the quality of working relationship by using the provider perspective section of working alliance inventory.
Michigan State University
Other
MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Randomized Trial
Acronym: MOSAIC Plus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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