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

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Conditions

  • Persons With Psychiatric Disorders

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Perinatal peer support — BEHAVIORAL
    The 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 support
    Participants 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 care
    Usual 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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Elizabeth M Yano, PhD MSPH
818-891-7711
David A Ganz, MD PhD MPH
(310) 478-3711
Nichole I Goodsmith, MD PhD (PRINCIPAL_INVESTIGATOR)

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