Recruiting

Doula Link

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07217561

Conditions

Perinatal Depression

Perinatal Anxiety

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Doula Link

Study Details

Brief 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

Study ID

NCT07217561

Start date

Oct 21, 2025

Status verified date

Oct, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Doula Link

Doulas randomized to this arm will receive: 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

no intervention: Doula Support as Usual

Doulas randomized to this arm will continue to provide care as usual

Interventions

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

Primary outcome measure

  • Acceptability of Intervention Measure [ Time Frame: 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 [ Time Frame: Directly following, 6-months after, and 12-months after doula training ]

Central Contacts and Locations

Central contacts

Elysia Larson

617-667-4051elarson@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Elysia Larson

6173655776elarson@bidmc.harvard.edu

Principal Investigator:

Elysia Larson, ScD, MPH

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • Doulas
  • Perinatal mental health
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-22.