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| Name | Class |
|---|---|
| Mae Stone Goode Foundation | OTHER |
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This study is a pilot, single-center, randomized controlled trial. It will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSE Intervention | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSE | Behavioral | The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is an evidence-based intervention that has been proven to reduce cases of post-partum depression among low-income and racially and ethnically diverse women. ROSE is administered to pregnant women in small group settings, typically in the same location that prenatal care is being provided (in this study, a hospital setting). It is divided into four 90-minute group sessions and teaches interpersonal psychotherapy-based skills that mitigate identified risk factors for PPD such as social support, stress management skills and communication. ROSE curriculum will be implemented using groups in a continuous cycle, with patients entering into the intervention curriculum at the time of their enrollment and continuing through until all 4 total sessions have been accomplished. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported in-hospital distress | Hospital distress will be measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) Stress subscale. Stress subscale ranges from 0 to 42 with higher scores indicating worse outcome. | 14 days |
| Subject-reported depressive symptom severity | Depressive symptom severity will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The scale ranges from 0-30 with higher scores indicating worse outcome. | 6 weeks postpartum |
| Subject-reported anxiety symptom severity | Anxiety symptom severity will be measured using the General Anxiety Disorder-7 (GAD-7) measurement scale. The scale ranges from 0 to 21 with higher scores indicating worse outcome. | 6 weeks postpartum |
| Clinical diagnosis of depression | Diagnosis of depression will be made using the Mini International Neuropsychiatric Interview (M.I.N.I) brief structured diagnostic interview which explores, in a standardized way, the main psychiatric disorders of Axis I of the DSM-IV TR. Only modules A and B (Major depressive episode and dysthymia) will be used. This structured interview contains questions with binary answers, with Yes indicating worse outcome. | 6 weeks postpartum |
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| Measure | Description | Time Frame |
|---|---|---|
| satisfaction with ROSE behavioral health intervention | Satisfaction score will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8). The scores range from 8-32, with greater satisfaction indicated by higher scores. | 14 days and 6 weeks postpartum |
| self-reported mother-infant bonding |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strong Hospital | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42209333 | Derived | Toscano M, Rubano A, Santos SR, Hartman R, Marinescu PS, Zlotnick C, Poleshuck EL. Feasibility, Acceptability, and Exploratory Efficacy of Implementing an Intervention for Preventing Postpartum Depression in Antepartum Hospitalized Patients With High-Risk Pregnancy Complications: A Mixed-Methods Experimental Study. Womens Health Issues. 2026 May 28:S1049-3867(26)00069-1. doi: 10.1016/j.whi.2026.04.002. Online ahead of print. |
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|
| Standard of Care | Other | Usual hospital care with no behavioral intervention |
|
Mother-infant bonding will be assessed over four domains by the Postpartum Bonding Questionnaire (PBQ). Scores range from 0-125, with worse outcome indicated by higher scores. |
| 6 weeks postpartum |
| self-reported functional status | Functional status will be assessed using the Inventory of Functional Status After Childbirth (IFSAC) measure. Scores range from 36-144, with higher scores indicating better outcome. | 6 weeks postpartum |
| percentage of eligible subjects who enrolled in the study | baseline |
| percentage of enrolled subjects who completed all inpatient study activities | 14 days |
| percentage of enrolled subjects who completed all inpatient plus outpatient study activities | 6 weeks postpartum |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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