Perinatal Peer Support for Veterans With Serious Mental Illness
Part of paid clinical trials in West Los Angeles, California.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT07362576
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Persons With Psychiatric Disorders
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Perinatal peer support — BEHAVIORALThe final intervention model, components, and timeline will be determined in an iterative process incorporating scientific evidence with input from Veterans, staff, and leadership in Aims 1 and 2. Preliminarily, the intervention is anticipated to begin with perinatal peer specialist contact by week 32 of pregnancy and continue for a duration of \~6 months. Session content may include psychoeducation and assessment of functional goals (e.g., related to employment, relationships, or illness management) and unmet social needs (e.g., housing, childcare, financial). Given that the initial postpartum period is a time of increased need for social support and vulnerability to mental health decline, peer support contact will continue until approximately 3 months postpartum.
Study Details
Veterans with serious mental illness (SMI) are at high risk of exacerbation of mental illness in pregnancy and postpartum, with consequences including poor pregnancy outcomes, decreased functioning, and impaired child development. Peer support could play a key role in supporting pregnant and postpartum Veterans with SMI. In this study, investigators will develop (Aims 1 and 2) and pilot (Aim 3) a peer specialist-delivered perinatal mental health intervention for Veterans with SMI, drawing from evidence-based models and input from Veterans, key VA clinical staff, and subject matter experts. The intervention will be piloted to assess its feasibility and acceptability, as well as exploratory clinical outcomes including postpartum functioning and mental health symptoms.
Key Dates
- Start date
- Jul 1, 2028
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Usual care plus perinatal peer supportParticipants in this arm will receive the perinatal peer support intervention, delivered by a trained Veteran perinatal peer specialist. They will continue to have access to routinely offered mental health and health services, including but not limited to Maternity Care Coordination, psychiatry, psychotherapy, and/or social work.
- No Intervention: Usual careUsual care will include access to routinely offered mental health and health services, including but not limited to Maternity Care Coordination, psychiatry, psychotherapy, and/or social work.
Primary Outcome Measure
Feasibility of recruitment and retention [ Time Frame: up to 9 months ]
Central Contacts
- Nichole I Goodsmith, MD PhD(310) 478-3711
- Kristina M Cordasco, MD MPH MSHS(310) 478-3711
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | Nichole I Goodsmith, MD PhD (PRINCIPAL_INVESTIGATOR) |