An interventional study of Patient Navigation (PN) and Problem Solving Therapy (PST) in Perinatal Anxiety and Perinatal Depression, sponsored by American University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by American University · Not applicable, Interventional, and Health services research
Among 654 studies in Psychological Well-Being with a site in United States — 189 open to participants now, 240 under way, 1 of them phase 3. Psychological Well-Being · United States.
Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 428th largest by planned enrollment of the 572 interventional ones that give a count, is one of 8 that started in 2027, is one of 514 with no phase, reaches primary completion later than 154 of the 238 other live ones, and was the 514th registered.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 45 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →189 of the 654 studies in Psychological Well-Being with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 402 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 158 (39%) stop at 75 or younger; 120 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →654 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 29 · Phase 3 10 · Phase 4 6
First in 1996; this study’s year is marked. 8 started in 2027.
Median enrollment 116 across the 572 interventional studies, 500 across the 81 observational. Of the 382 that completed or were terminated, 120 (31%) have results posted.
53 of 654 have an industry lead sponsor. The 10 most frequent:
American University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
American University has 1 study filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
99 of the studies in Psychological Well-Being with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07011459Tulane UniversityThe Cooking for Health Optimization and Disease Prevention (CHOP) Trial | 2026-11 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06915259University of PennsylvaniaDoula Model of Care | 2026-11 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
Among the 654 studies in Psychological Well-Being with a site in United States, from their registry updates:
The goal of this clinical trial is to learn if an intervention can improve mental health outcomes among pregnant and postpartum Latinas. The main questions it answers are:
Is a collaborative, community health worker and social worker intervention is feasible within a community health setting? Is a collaborative, community health worker and social worker intervention is acceptable among Latina individuals in Central Texas? Do participants experience an improvement in perinatal mental health outcomes during or after the collaborative intervention?
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Community health workers (CHWs) will provide patient navigation to assess and address health related social needs, while social worker (SWs) will focus on mental health needs, and provide a standardized, PST intervention.
Behavioral: Patient Navigation (PN) · Behavioral: Problem Solving Therapy (PST)
Patient navigation (PN) is an evidence-based intervention that removes barriers to healthcare services. PN typically supports patients by identifying healthcare services and addressing any access barriers such as location, cost, or transportation.
Problem solving therapy (PST) is an evidence-based, mental health intervention that consists of cognitive behavioral and problem-solving strategies aimed at improving mental health.
Feasibility- Recruitment
Feasibility will be assessed based on recruitment metrics, which includes the number and percent of patients screened and enrolled per week.
Time frame: From enrollment until we reach 45 participants (Up to 24 weeks)
Feasibility- Attrition
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.
Time frame: From enrollment until at least 30 participants complete the study (Up to 24 weeks)
Feasibility- Retention
Feasibility will be assessed based on retention, or the proportion of participants who remain in the study through to its conclusion.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Completion of Intervention
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Duration
Feasibility will be assessed based on duration, or the average amount of time required to complete the intervention per participant.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Feasibility- Completion of Study Assessments
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Acceptability
Acceptability will be assessed based on patient satisfaction, retention, and qualitative interviews.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Depression: Edinburgh Postpartum Scale (EPDS)
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Anxiety: Generalized Anxiety Disorder-7
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Post-traumatic stress disorder: Impact of Event Scale-6
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Health related social needs: PhenX
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Respectful Care: MADM
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Respectful Care: MORi
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.
Time frame: From enrollment to the end of the study at 8 weeks postpartum
Plan to share: Yes — All individual participant data that is shared will be aggregated and deidentified. Access to this data will require PI permission that will include conditions for using the data such as time limitations and co-authorship.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The investigators anticipate all study data will be available for analysis by 03/01/2028.
Access criteria: All individual participant data that is shared will be aggregated and deidentified. Access to this data will require PI permission that will include conditions for using the data such as time limitations and co-authorship. Data will be stored on encrypted, web-based servers via OneDrive. Metadata (e.g., intervention protocols, interview guides, data dictionaries, etc.) will be stored via the American University Research Archive: https://aura.american.edu/
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Sep 2027, 8 months later.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 8 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
American University