Perinatal Anxiety, Perinatal Depression
Conditions
Keywords
perinatal, mental health, community health worker, social worker, Latina
Brief summary
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: * Receive 3 community health worker and social worker sessions during pregnancy. * Receive 3 community health worker and social worker sessions postpartum (up to 12 weeks). * Complete a survey at three timepoints (baseline, 2 weeks postpartum and 12 weeks postpartum).
Interventions
BEHAVIORALPatient Navigation (PN)
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.
BEHAVIORALProblem Solving Therapy (PST)
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.
Sponsors
American University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Community Health Workers will implement patient navigation (PN), which is an evidence-based intervention that removes barriers to healthcare services for underserved populations. Social workers will implement problem solving therapy (PST), which is an evidence-based, mental health intervention that consists of cognitive behavioral and problem-solving strategies aimed at improving mental health.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant * Identify as Hispanic or Latina * Receive social services from El Buen Samaritano and/or obstetric services from LoneStar Circle of Care * Between 20- and 32-weeks' gestation * 18 years or older * Screen positive for depression or anxiety (PHQ-4≥3 on either subscale)
Exclusion criteria
* Not pregnant * Do not identify as Hispanic or Latina * Do not receive services at El Buen Samaritano or LoneStar Circle of Care * Before 20 weeks pregnant or after 32 weeks pregnant * Under 18 * Do not screen positive for depression or anxiety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTPrincipal Investigator
PRINCIPAL_INVESTIGATORLiana Petruzzi, PhD, LCSW
American University
Outcome results
None listed