Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT07217561

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

Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-22

90

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Doulas are trained individuals who offer informational, emotional, and physical support to their pregnant, birthing, and postpartum clients. The goal of this clinical trial is to learn if a new intervention (called "Doula Link") is feasible to implement and acceptable to both doulas and their clients. The main questions it aims to answer are: * Is Doula Link feasible to implement and acceptable to doulas and their clients? * What are the preliminary differences in depression and anxiety between individuals working with doulas who received Doula Link compared to those who did not receive Doula Link? Researchers will compare "Doula Link" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health outcomes in postpartum individuals. Doulas will be randomly assigned to either receive "Doula Link" or continue with their practice as usual. Participating doulas assigned to Doula Link will receive training mental health and implementing an intervention called "Our Babies and Us"; receive access to a toolkit; receive access to perinatal psychiatrists and referral specialists for consultations; receive access to a support group All participating doulas will be invited to complete surveys about their experience with Doula Link (if assigned to that group) and their experience providing care for their clients. All participating clients (pregnant and postpartum individuals) will be invited to complete surveys about their experiences with their doulas, their own mental health, and their experiences with the health system.

CONDITIONS

Official Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For doulas: currently providing prenatal or postpartum support to at least one client
  • Plan 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
  • Fluent in English
  • 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
  • Fluent in English or Spanish
Not Eligible

You will not qualify if you...

  • Not meeting inclusion criteria

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

E

Elysia Larson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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