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

NCT07217561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-10-22

No results posted yet for this study

Summary

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

  • Perinatal Depression
  • Perinatal Anxiety

Interventions

BEHAVIORAL

Doula Link

1\) a doula-specific mental health toolkit; 2) training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3) training for, and access to expert consultations with perinatal psychiatric specialists through MCPAP for Moms; 4) training on perinatal mental health; 5) access to doula support groups

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217561 on ClinicalTrials.gov