Testing "Doula Link" for Perinatal Mental Health

This study is testing an intervention called "Doula Link" to see if it can help improve mental health for pregnant and new parents. Many people experience anxiety and depression during pregnancy and after birth. Doulas are trained professionals who support families during this time. "Doula Link" provides doulas with tools like a mental health toolkit, training in a stress-reduction program, and access to mental health specialists. The study wants to find out if "Doula Link" is practical to use and if doulas and their clients find it helpful. Researchers will also look for early signs of differences in depression and anxiety between people who work with doulas using "Doula Link" versus those with doulas using standard care. The study plans to enroll 90 participants and is currently recruiting doulas and their clients in Massachusetts.

Study design
This interventional study aims to enroll 90 participants, comparing the "Doula Link" intervention to usual doula practice.
What's involved
For clients, acceptability will be measured at 32 weeks gestation and 6 weeks postpartum. For doulas, acceptability and feasibility will be measured directly after training, and then at 6 and 12 months after training.
Compensation
Not stated in the trial record.
Follow-up
Clients will be followed until 6 weeks postpartum. Doulas will be followed for 12 months after their training.

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NCT07217561

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

Recruiting
NAAll AgesInterventionalHealth services
Beth Israel Deaconess Medical Center
~90 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Doula Link

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of Intervention Measure
Measured over 32-weeks gestation and 6 weeks postpartum postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.
+1 more outcome measured
Perinatal Depression
Perinatal Anxiety
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

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
  • Acceptability of Intervention Measure32-weeks gestation and 6 weeks postpartum postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.

    Perception among postpartum individuals in the Doula Link arm that Doula Link is agreeable and perception among postpartum individuals in the Doula Link arm that Doula Link and its individual components is agreeable. The "Acceptability of Intervention Measure (AIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better acceptability.

  • Feasibility of InterventionDirectly following, 6-months after, and 12-months after doula training

    How well Doula Link and its individual components can be successfully delivered to doulas. The "Feasibility of Intervention Measure" (FIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better feasibility.