Trial · NCT07880457
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility- Recruitment | From enrollment until we reach 45 participants (Up to 24 weeks) | Feasibility will be assessed based on recruitment metrics, which includes the number and percent of patients screened and enrolled per week. |
| Primary | Feasibility- Attrition | From enrollment until at least 30 participants complete the study (Up to 24 weeks) | Feasibility will be assessed based on attrition, or the proportion of participants who withdraw from the study before its completion.It will be calculated as the number of participants lost to follow-up divided by the total number initially enrolled. |
| Primary | Feasibility- Retention | From enrollment to the end of the study at 8 weeks postpartum | Feasibility will be assessed based on retention, or the proportion of participants who remain in the study through to its conclusion. |
| Primary | Feasibility- Completion of Intervention | From enrollment to the end of the study at 8 weeks postpartum | Feasibility will be assessed based on number of participants who complete of Intervention, which is the percentage of participants who receive the "full dose" or intended components of the intervention. |
| Primary | Feasibility- Duration | From enrollment to the end of the study at 8 weeks postpartum | Feasibility will be assessed based on duration, or the average amount of time required to complete the intervention per participant. |
| Primary | Feasibility- Completion of Study Assessments | From enrollment to the end of the study at 8 weeks postpartum | Feasibility will be assessed based on completion of study assessments. This will be defined as the proportion of participants who complete required data collection activities at each timepoint. |
| Primary | Acceptability | From enrollment to the end of the study at 8 weeks postpartum | Acceptability will be assessed based on patient satisfaction, retention, and qualitative interviews. |
| Secondary | Depression: Edinburgh Postpartum Scale (EPDS) | From enrollment to the end of the study at 8 weeks postpartum | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire designed to screen for symptoms of depression during the perinatal period. The Edinburgh Postnatal Depression Scale (EPDS) has been validated for use with Latina populations, with studies showing a Spanish version performs adequately. |
| Secondary | Anxiety: Generalized Anxiety Disorder-7 | From enrollment to the end of the study at 8 weeks postpartum | The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale used to screen for and assess the severity of generalized anxiety disorder. The GAD-7 has been validated in both general and perinatal populations, demonstrating strong psychometric properties, including good reliability and construct validity. |
| Secondary | Post-traumatic stress disorder: Impact of Event Scale-6 | From enrollment to the end of the study at 8 weeks postpartum | The Impact of Event Scale-6 (IES-6) is a brief, 6-item self-report measure used to assess post-traumatic stress symptoms in response to a specific stressful or traumatic event. The IES-6 has demonstrated strong reliability and validity in perinatal populations, including women who have experienced traumatic birth or pregnancy complications. |
| Secondary | Health related social needs: PhenX | From enrollment to the end of the study at 8 weeks postpartum | The PhenX Toolkit is a publicly available resource that provides standardized, consensus-based measures for use in biomedical and public health research. It includes a wide range of validated instruments to measure health related social needs. For example, the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE) is a nationally recognized, evidence-informed tool designed to assess social determinants of health in clinical and community settings. The PRAPARE tool has been widely used and validated in diverse populations, including Latina communities, and is available in Spanish. |
| Secondary | Respectful Care: MADM | From enrollment to the end of the study at 8 weeks postpartum | The Mothers' Autonomy in Decision Making (MADM) scale is a 7-item, validated self-report measure that evaluates the extent to which individuals feel they were supported to make informed decisions about their maternity care. MADM has been validated with perinatal and Latina populations. |
| Secondary | Respectful Care: MORi | From enrollment to the end of the study at 8 weeks postpartum | The Mothers on Respect Index (MORi) is a 14-item measure that assesses the degree of respectful, dignified, and non-coercive care received during maternity care. MORi has been validated with perinatal and Latina populations. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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