Depression Clinical Trial
— MOSAIC Plus OTOfficial title:
MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Open Trial
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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | April 14, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Michigan State University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Provider Competencies | Number of participants reporting on competency of providers by using Competency Assessment Inventory (CAI). | 6 and 9 months | |
Other | Quality of working relationship-provider perspective | 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. | 3, 6 and 9 months | |
Primary | 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 | |
Primary | 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 | |
Primary | Quality of working relationship | Evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR) | 9 months | |
Primary | 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 | |
Primary | 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 | 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. | baseline, 3, 6 and 9 months | |
Secondary | 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. | baseline, 3, 6 and 9 months | |
Secondary | 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. | baseline, 3, 6 and 9 months | |
Secondary | 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. | baseline, 3, 6 and 9 months | |
Secondary | 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. | baseline, 3, 6 and 9 months | |
Secondary | 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. | baseline, 3, 6 and 9 months |
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