Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder (EMBRACE)

June 9, 2026 updated by: Lisa A. Marsch, Trustees of Dartmouth College

A Digitally Enhanced Model of Peer Doula Support for Substance Use Disorder and Peripartum Care

The goal of this pilot study is to learn if a digitally enhanced peer doula program for people with perinatal substance use disorders (PSUD) is feasible and acceptable to patients and staff at two clinics.

Participants will include staff members, such as healthcare providers, recovery support doulas, and administrators, who work at one of the two clinics. It will also include PSUD patients receiving care through the digitally enhanced peer doula program.

Participants will be asked to complete short surveys and take part in a one-time interview with research staff.

This study will also explore engagement in perinatal substance use disorder treatment and prenatal and postpartum visits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Over the past two decades, rates of substance use during pregnancy have increased fourfold. Overdose is a leading cause of mortality among patients with perinatal substance use disorders (PSUD). Interventions to address SUD during pregnancy and postpartum are critical to reduce mortality and the impact of SUD-related harms for parents and their infants.

Engagement in SUD and perinatal care can improve outcomes for PSUD and their infants, including reducing the risks of preterm delivery and low birthweight. Rates of adequate prenatal care receipt are low for PSUDs, with one recent study estimating that only an estimated 50% of PSUDs in the United States (US) receive adequate prenatal care. These healthcare disparities also extend to the postpartum period, where PSUDs have a 53% decrease in the odds of attending at least one postpartum obstetric visit, compared to patients without an SUD. PSUDs are also less likely to receive SUD treatment during the year postpartum due to lapses in health insurance. Stigma from health professionals and lack of trust in healthcare providers can prevent PSUD from seeking perinatal health services and SUD treatment. PSUD also report numerous barriers to effectively communicating with healthcare providers and want more evidence-based information about delivery, postpartum health, breastfeeding, and the impact of medication for opioid use disorder (MOUD) from their healthcare team. Lack of access to healthcare can have devastating consequences, including a return to substance use and increased risk of fatal overdose. Interventions improving engagement with prenatal and postpartum care and SUD treatment are urgently needed.

A growing body of research suggests that doula care may improve engagement in healthcare for patients with behavioral health conditions. A doula is a trained professional who provides comprehensive physical, emotional, and informational support to patients before, during, and/or after childbirth. Doula care has been widely studied, with reviews suggesting that doula support can decrease rates of preterm birth, Cesarean birth, and low birth weight babies.

Doula care promises to directly improve outcomes and care experiences for PSUD. A growing body of literature has studied how doula support may improve outcomes for patients with behavioral health conditions including postpartum depression and SUD. The Illinois Department of Health/Division of Substance Use Prevention and Recovery pilot specifically use peer doulas, who have dual certifications as certified peer support specialists and doulas. Peer doulas with experience in both SUD and perinatal care could be especially beneficial for PSUD and provide guidance in navigating both SUD and perinatal healthcare systems.

Only one known study has enrolled PSUD to examine their experiences with doula care during pregnancy and postpartum. Twenty-three patients with OUD who had engaged with the Philadelphia doula care model were enrolled in a mixed-methods study examining perceptions of engaging with a doula. Participants overwhelmingly reported positive experiences with the doula program, finding the program acceptable and helpful. They appreciated the ability to engage with the doulas through phone, text, video, or in-person in the community. Participants noted that the doulas helped manage their stress and anxiety, while providing critical assistance navigating the healthcare system. Importantly, participants and staff both agreed that doula involvement reduced perceptions of stigma from healthcare providers.

Study Type

Observational

Enrollment (Estimated)

100

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 Contact Backup

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • Oregon
      • Portland, Oregon, United States, 97239
        • The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Staff participants and patient participants will be selected from two participating clinical sites that have implemented the digitally enhanced peer doula model of care.

Description

Staff Participant

Inclusion Criteria:

  1. 18 years of age or older.

  2. Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:

    1. Provider (including MD, CNM, DO, PA, NP, nurse, medical assistant, behavioral health clinician, social worker, lactation consultant and/or other clinical roles that provide care to patients).
    2. Peer doulas.
    3. Administrator (including front desk staff, scheduler, clinic and/or team manager).
    4. Site leadership.
  3. Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Unwilling or unable to provide consent
  2. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities

Patient Participant (Cohort 1 & Cohort 2)

Inclusion Criteria

  1. 18 years of age or older

  2. Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services

    •Either

    1. Not currently engaged in the digitally enhanced peer doula model and no prior exposure to the model or less than 30 days exposure to the model if newly enrolled, AND currently pregnant or up to 6 weeks postpartum.

      OR

    2. Currently engaged in the digitally enhanced peer doula model for more than 30 days, AND currently pregnant or up to one year postpartum
  3. Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Unable or unwilling to provide consent to participate in study activities
  2. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities
  3. Currently unable to engage in the digitally enhanced peer doula model or attend research visits

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Participants Cohort 1
Patient Participants who have not yet been exposed to the peer doula model of care or have been exposed for less than 30 days
Other: Digitally Enhanced Peer Doula Model of Care
In the digitally enhanced peer doula model of care, patients with perinatal substance use disorder are partnered with a recovery support peer doula who is able to provide synchronous or asynchronous support. This support can include in-person and text-based and/or telehealth support, in addition to assistance scheduling and arranging transport to appointments for both SUD and peripartum care, and assisting with access to food, transportation and housing. Additionally, these patients are offered a free smartphone and data plan for pregnancy and one-year postpartum.
Patient Participants Cohort 2
Patient Participants who have been exposed to the peer doula model of care for at least 30 days
Other: Digitally Enhanced Peer Doula Model of Care
In the digitally enhanced peer doula model of care, patients with perinatal substance use disorder are partnered with a recovery support peer doula who is able to provide synchronous or asynchronous support. This support can include in-person and text-based and/or telehealth support, in addition to assistance scheduling and arranging transport to appointments for both SUD and peripartum care, and assisting with access to food, transportation and housing. Additionally, these patients are offered a free smartphone and data plan for pregnancy and one-year postpartum.
Site Staff Participants
Site staff participants who have been exposed to the peer doula model of care at their clinical site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure (FIM)
Time Frame: At enrollment

Site staff participants will complete the FIM, a 4-item survey, that examines the feasibility of implementing the digitally enhanced peer doula model in routine obstetric settings.

Using a five-point Likert scale, the FIM has 4 items examining whether an innovation is implementable, possible, doable, and easy to use. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater feasibility. Two versions of the FIM will be completed by Site staff participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the FIM will assess the acceptability of the peer doula component of the model.
At enrollment
Acceptability of Intervention Measures (AIM)
Time Frame: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)

Site staff and patient participants will complete the AIM, a 4-item survey, that assesses the acceptability of the digitally enhanced peer doula model in routine obstetric settings. The survey asks participants to rate the acceptability of the model from completely disagree to completely agree.

Using a five-point Likert scale, the AIM has 4 items examining whether an innovation meets participant approval, is appealing, is welcomed, and is liked. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater acceptability. Two versions of the AIM will be completed by patient participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the AIM will assess the acceptability of the peer doula component of the model. Site staff will only complete the second version.

.
At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Prenatal Obstetric Visits
Time Frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

The number of prenatal visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model.

Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort.
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Number of Postpartum Obstetric Visits
Time Frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
The number of postpartum visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model. Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort.
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Engagement in substance use disorder (SUD) treatment
Time Frame: At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)

Engagement in substance use disorder (SUD) treatment will be assessed via the Oregon Hope Engagement in Addiction Treatment Survey (OR HOPE). This will be measured by evaluating the percentage of patients reporting participation in SUD services before and after exposure to the model.

Items measured will be the following:

  • Types of SUD treatment received
  • Frequency of SUD treatment
At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
Engagement in Peer Doula Support
Time Frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

Sites will abstract data from each peer doula contact with study participants. This data will include the following:

  1. Modality of each encounter (e.g., virtual, phone-based, or in-person)
  2. Location of contact (e.g., obstetric clinic, other healthcare setting, patient home, or community)
  3. Types of support provided (e.g., recovery, pregnancy, postpartum, housing, transportation, food, lactation, or other).
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

Collaborators and Investigators

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

Sponsor

Trustees of Dartmouth College

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Lisa A. Marsch, PhD, Dartmouth College

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTN-0157
  • UG1DA040309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant level data will be posted to the NIDA data share website

IPD Sharing Time Frame

IPD will be available on the NIDA data share website per NIH guidelines after publication of the primary outcomes with no end date

IPD Sharing Access Criteria

The NIDA data share website is public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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