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Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health

NCT07217561 · Beth Israel Deaconess Medical Center
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Official title
Doula Link for Perinatal Mental Health - Trial
About this study
Many people experience anxiety, depression, or other mental health concerns during the pregnancy, birth, and the postpartum periods. Despite interventions that work to prevent and treat, most perinatal depression and anxiety is unprevented and untreated. Doulas are trained professionals who offer emotional, educational, and physical support during this period. Their support has been shown to improve health outcomes for pregnant and postpartum individuals. This study will pilot test a multi-component intervention, called Doula Link for Perinatal Mental Health (Doula Link), that gives doulas the tools to directly support mental health. Through Doula Link, doulas will receive: 1. a doula-specific mental health toolkit adapted from MCPAP for Moms, a statewide psychiatry access program; 2. training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3. access to expert consultations and client referrals with perinatal psychiatric specialists through MCPAP for Moms. 4. training on perinatal mental health 5. access to doula support groups By bringing together clinicians, doulas, and families, the goal of Doula Link is to support doulas to support their clients' mental health. Investigators hypothesize that building a program with doulas to provide direct support and link health system and community resources is an attainable intervention to expand access to mental health support.
Eligibility criteria
Inclusion Criteria: * For doulas: currently providing prenatal or postpartum support to at least one client; plant to provide prenatal or postpartum support to at least three clients in the next six months; work in Massachusetts; did not participate in development of the intervention; available to participate in in-person training; English language fluency * For clients: Pregnant or no more than 12 weeks postpartum at enrollment; served by one of the 30 study doulas; live in, and plan to give birth in Massachusetts; fluency in either English or Spanish Exclusion Criteria: * Not meeting inclusion criteria
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-10-21
Estimated completion: 2027-06
Last updated: 2025-10-22
Interventions
Behavioral: Doula Link
Primary outcomes
  • Acceptability of Intervention Measure (32-weeks gestation and 6 weeks postpartum postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.)
  • Feasibility of Intervention (Directly following, 6-months after, and 12-months after doula training)
Sponsor
Beth Israel Deaconess Medical Center · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactElysia Larson · contact · elarson@bidmc.harvard.edu · 617-667-4051
All locations (1)
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States