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

Doula Link for Perinatal Mental Health - Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Doula Link, a program that gives doulas mental health training, tools, and support. Doulas support people during pregnancy, birth, and after birth. The study includes doulas and their clients in Massachusetts and compares Doula Link with usual doula care to see if it is easy to use, is well liked, and may help with depression and anxiety after birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Doulas: Currently support at least one client during pregnancy or after birth.
  • Doulas: Plan to support at least three clients during pregnancy or after birth in the next six months.
  • Doulas: Work in Massachusetts and did not help develop Doula Link.
  • Doulas: Can attend in-person training and speak English fluently.
  • Clients: Are pregnant or gave birth no more than 12 weeks before joining.
  • Clients: Receive care from one of the 30 study doulas.
  • Clients: Live in Massachusetts and plan to give birth there.
  • Clients: Speak English or Spanish fluently.

Who can't join

  • Anyone who does not meet the rules for their group listed above.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MA