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

October 21, 2025 updated by: Elysia Larson, Beth Israel Deaconess Medical Center

Doula Link for Perinatal Mental Health - Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Many people experience anxiety, depression, or other mental health concerns during the pregnancy, birth, and the postpartum periods. Despite interventions that work to prevent and treat, most perinatal depression and anxiety is unprevented and untreated. Doulas are trained professionals who offer emotional, educational, and physical support during this period. Their support has been shown to improve health outcomes for pregnant and postpartum individuals.

This study will pilot test a multi-component intervention, called Doula Link for Perinatal Mental Health (Doula Link), that gives doulas the tools to directly support mental health. Through Doula Link, doulas will receive:

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

By bringing together clinicians, doulas, and families, the goal of Doula Link is to support doulas to support their clients' mental health. Investigators hypothesize that building a program with doulas to provide direct support and link health system and community resources is an attainable intervention to expand access to mental health support.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Elysia Larson, ScD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
No Intervention: Doula Support as Usual
Doulas randomized to this arm will continue to provide care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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

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.
Directly following, 6-months after, and 12-months after doula training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness of Intervention
Time Frame: 32-weeks gestation and 6 weeks postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.

The perceived fit and relevance of Doula Link and its individual components among doulas and their clients in the Doula Link arm.

The "Appropriateness of Intervention Measure" (IAM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better appropriateness.
32-weeks gestation and 6 weeks postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.
Fidelity of implementation of Our Babies and Us
Time Frame: Every two weeks after client enrollment for a total of six time points.
The degree to which the Our Babies and Us component of Doula Link is implemented by the doulas to each client. This will be measured using the Our Babies and Us fidelity scale, which measures each topic across three dimensions. Possible scores range from 0 to 6 with higher scores indicating higher fidelity.
Every two weeks after client enrollment for a total of six time points.
Reach of Our Babies and Us component
Time Frame: At 6 weeks postpartum
The proportion of clients who receive part or all of the Our Babies and Us component of the intervention.
At 6 weeks postpartum
Symptoms of depression
Time Frame: 32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum
Client scores on the Edinburgh Postnatal Depression Scale (EPDS). Possible range of scores is 0 to 30 with higher scores indicating a worse outcome.
32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum
Symptoms of anxiety
Time Frame: 32-weeks gestation and 6- and 16-weeks postpartum
Symptoms of anxiety as measured by the generalized anxiety scale (GAD-7). The possible range of scores is 0 to 21 with higher scores indicating a worse outcome.
32-weeks gestation and 6- and 16-weeks postpartum
Feasibility of Our Babies and Us
Time Frame: Directly following, 6-months after, and 12-months after doula training
How well doulas can implement the our Babies and Us component to their clients. 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.
Directly following, 6-months after, and 12-months after doula training
Reach of MCPAP for Moms component
Time Frame: At the completion of the doula intervention
The proportion of doulas who call to access the MCPAP for Moms component of the intervention.
At the completion of the doula intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Help-seeking
Time Frame: 32-weeks gestation and 6- and 16-weeks postpartum
Clients scores on the barriers to access to care evaluation scale (BACE). The possible range of scores on the BACE is 0 to 90 with higher scores indicating a worse outcome, i.e. more barriers to access to care.
32-weeks gestation and 6- and 16-weeks postpartum
Treatment participation
Time Frame: 32-weeks gestation and 6- and 16-weeks postpartum

Proportion of individuals who have symptoms of depression (denominator) who report accessing treatment (numerator) in the past six weeks.

Denominator is defined as a score of 10 or higher on the Edinburgh Postpartum Depression Scale (EPDS), indicating any thoughts of self-harm on the EPDS, or having been diagnosed with depression by a clinician.

Numerator is defined as having seen a mental health professional or been prescribed medication to treat a perinatal mental health disorder.
32-weeks gestation and 6- and 16-weeks postpartum
Skills used
Time Frame: 32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum
Our babies and us stress reduction skill used. The "Mothers and Babies Skills Utilization Scale" will be used. This 11-item scale assesses aspects of skills using a five-point frequency Likert scale. The full scale has a possible range of 0 to 44 with higher scores indicating a better outcome, i.e. more skills used.
32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 3, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Estimated)

October 16, 2025

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIDMC2023P000426
  • K01MH133966 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Per institutional policy, IPD cannot be shared with other researchers without a formal data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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