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

Not Applicable

Recruiting

• Conditions: Perinatal Depression; Perinatal Anxiety

• Registration Number: NCT07217561
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-03
• Study First Submitted QC: 2025-10-14
• Study First Posted: 2025-10-16
• Study Start: 2025-10-21
• Last Update Submitted: 2025-10-21
• Last Update Posted: 2025-10-22
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure	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.
Feasibility of Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Appropriateness of Intervention	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.
Fidelity of implementation of Our Babies and Us	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.
Reach of Our Babies and Us component	At 6 weeks postpartum	The proportion of clients who receive part or all of the Our Babies and Us component of the intervention.
Symptoms of depression	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.
Symptoms of anxiety	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.
Feasibility of Our Babies and Us	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.
Reach of MCPAP for Moms component	At the completion of the doula intervention	The proportion of doulas who call to access the MCPAP for Moms component of the intervention.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States