Pathways to Perinatal Mental Health Equity

Part of paid clinical trials in Shrewsbury, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06790641
Status
Recruiting
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Conditions

  • Obstetric Care
  • Peer Support
  • Perinatal Anxiety
  • Perinatal Depression
  • Perinatal Depression, Substance Use
  • Social Determinants of Health (SDOH)
  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Program in Support of Moms (PRISM) — BEHAVIORAL
    Program in Support of Moms (PRISM): a practice-level intervention with implementation support that helps obstetric practices integrate mental health care for perinatal individuals. To help obstetric practices implement pathways for screening, assessment, and a stepped intervention response for mental health problems and social determinants of health. PRISM offers training in trauma informed and equitable care, technical assistance, and implementation and change management support.
  • PSI Peer Support — BEHAVIORAL
    Postpartum Support International (PSI) Peer Support: a service administered by PSI that pairs perinatal individuals with a volunteer peer mentor who provides support, psychoeducation, behavioral activation, and navigation services, which includes planning, goal setting, and practical tools to manage parenting and mental health symptoms.

Study Details

Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.

Key Dates

Start date
Dec 5, 2025
Status verified
Apr 2026
Primary completion
Oct 1, 2030
Completion
Oct 1, 2030

Study Design

Enrollment
1,270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Healthcare-Community Partnership approach
    The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists.
  • Active Comparator: Healthcare system approach
    The Healthcare system approach will include the PRogram In Support of Moms (PRISM) model alone.

Primary Outcome Measure

Change in perinatal individual depression symptoms as measured by Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9) [ Time Frame: Baseline to up to 13 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolShrewsburyMassachusetts01545
Carolyn M Friedhoff, MBE
[email protected]
3059726131
Padma Sankaran, MA
[email protected]
5085613731
Nancy Byatt, DO, MS, MBA, DFAPA, FACLP (PRINCIPAL_INVESTIGATOR)

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UMass Chan Medical School· Shrewsbury, MA

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