Trial · NCT07880457
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
NCT07880457, Not applicable, Not yet recruiting, American University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention. Trials, record NCT07880457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880457
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
- NCT number
- NCT07880457
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 45 participants, estimated
- Lead sponsor
- American University
- Conditions
- Perinatal Anxiety, Perinatal Depression
- Interventions
- Patient Navigation (PN), Problem Solving Therapy (PST)
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K01MD019724 | Advancing Perinatal Mental Health: A Feasibility Study of an Integrated Social Work and Community Health Approach | PETRUZZI, LIANA J | AMERICAN UNIVERSITY | NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES | 2024 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07880457
GET https://conductscience.org/api/trials/v1/NCT07880457/registered