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

NCT07642947 | Not Yet Recruiting

• 2 other identifiers: CTN-0157UG1DA040309
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Perinatal Substance Use

Keywords

Peer Doula; Perinatal Substance Use Disorder; Digital Model of Care

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention Measure (FIM)

  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)

  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 Outcomes (4)

• Number of Prenatal Obstetric Visits

  Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

• Number of Postpartum Obstetric Visits

  Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

• Engagement in substance use disorder (SUD) treatment

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

• Engagement in Peer Doula Support

  Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

Study Arms (3)

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

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

Site Staff Participants

Site staff participants who have been exposed to the peer doula model of care at their clinical site

Interventions

Digitally Enhanced Peer Doula Model of Care OTHER

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 1; Patient Participants Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older.
• Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:
• 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).
• Peer doulas.
• Administrator (including front desk staff, scheduler, clinic and/or team manager).
• Site leadership.
• Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

You may not qualify if:

• Unwilling or unable to provide consent
• 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)
• years of age or older
• Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services
• Either
• 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.
• Currently engaged in the digitally enhanced peer doula model for more than 30 days, AND currently pregnant or up to one year postpartum
• Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
• Unable or unwilling to provide consent to participate in study activities
• 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
• Currently unable to engage in the digitally enhanced peer doula model or attend research visits

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)

Portland, Oregon, 97239, United States

Location

Related Publications (31)

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Study Officials

• Lisa A. Marsch, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Saunders, PhD

CONTACT

603-646-7006; Elizabeth.C.Saunders@dartmouth.edu

Kathleen Bell, MS

CONTACT

603-646-7038; kathleen.bell@dartmouth.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Northeast Node of the National Drug Abuse Treatment Clinical Trials Network (CTN)

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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
• Access Criteria: The NIDA data share website is public

Locations

US (2)