Perinatal Substance UseEMBRACENCT07642947
Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder
An observational study of Perinatal Substance Use, run by Trustees of Dartmouth College at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perinatal Substance Use
- What is being tested?
- Digitally Enhanced Peer Doula Model of Care
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2026to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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.
Show all 14Show fewer
- Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
- 18 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.
- OR
- 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.
Who cannot join
- 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)
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Lisa Lamadriz, 603-308-9120, lisa.a.lamadriz@hitchcock.org
The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)
Portland, Oregon, 97239
Alisa Patten, 971-442-3625, pattena@ohsu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Perinatal Substance Use
- Being tested
- Digitally Enhanced Peer Doula Model of Care
- Keywords
- Peer Doula, Perinatal Substance Use Disorder, Digital Model of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally Enhanced Peer Doula Model of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
.
Measured: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)
Secondary outcomes (4)
Number of Prenatal Obstetric Visits
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.
Measured: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Number of Postpartum Obstetric Visits
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.
Measured: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Engagement in substance use disorder (SUD) treatment
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
Measured: At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
Engagement in Peer Doula Support
Sites will abstract data from each peer doula contact with study participants. This data will include the following:
- Modality of each encounter (e.g., virtual, phone-based, or in-person)
- Location of contact (e.g., obstetric clinic, other healthcare setting, patient home, or community)
- Types of support provided (e.g., recovery, pregnancy, postpartum, housing, transportation, food, lactation, or other).
Measured: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Perinatal Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa A. Marsch, Trustees of Dartmouth College
- Investigators
- Lisa A. Marsch, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642947
- Sponsor's protocol ID
- CTN-0157
- Other IDs
- UG1DA040309
- Acronym
- EMBRACE
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant level data will be posted to the NIDA data share website
Publications
Ruiz MG, Dronamraju R. Utilizing doula care to support substance use disorder in the postpartum period. Association of State and Territorial Health Officials,, 2023.
Gannon M, Hand D, Short VL, Carrubba T, Thiele G, Pancoe S, Lawson S, Haerizadeh-Yazdi N, Keith SW, Abatemarco D. "Someone is there with you through this [pregnancy] that isn't seeing you through a negative lens": Considerations for integrating doula referrals into opioid treatment programs. J Subst Use Addict Treat. 2025 Feb;169:209585. doi: 10.1016/j.josat.2024.209585. Epub 2024 Nov 17.
PubMed 39551148Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths From Suicide and Overdose in Colorado, 2004-2012. Obstet Gynecol. 2016 Dec;128(6):1233-1240. doi: 10.1097/AOG.0000000000001695.
PubMed 27824771Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1.
PubMed 30091969Nidey N, Kair LR, Wilder C, Froehlich TE, Weber S, Folger A, Marcotte M, Tabb K, Bowers K. Substance Use and Utilization of Prenatal and Postpartum Care. J Addict Med. 2022 Jan-Feb 01;16(1):84-92. doi: 10.1097/ADM.0000000000000843.
PubMed 33758116Han B, Compton WM, Einstein EB, Elder E, Volkow ND. Pregnancy and Postpartum Drug Overdose Deaths in the US Before and During the COVID-19 Pandemic. JAMA Psychiatry. 2024 Mar 1;81(3):270-283. doi: 10.1001/jamapsychiatry.2023.4523.
PubMed 37991773Mazel S, Alexander K, Cioffi C, Terplan M. Interventions to Support Engagement in Addiction Care Postpartum: Principles and Pitfalls. Subst Abuse Rehabil. 2023 Jul 3;14:49-59. doi: 10.2147/SAR.S375652. eCollection 2023.
PubMed 37424702Goldman-Mellor S, Margerison CE. Maternal drug-related death and suicide are leading causes of postpartum death in California. Am J Obstet Gynecol. 2019 Nov;221(5):489.e1-489.e9. doi: 10.1016/j.ajog.2019.05.045. Epub 2019 Jun 4.
PubMed 31173749Bruzelius E, Martins SS. US Trends in Drug Overdose Mortality Among Pregnant and Postpartum Persons, 2017-2020. JAMA. 2022 Dec 6;328(21):2159-2161. doi: 10.1001/jama.2022.17045.
PubMed 36472602Eliason EL, Gordon SH. The Association Between Postpartum Insurance Instability and Access to Postpartum Mental Health Services: Evidence From Colorado. Womens Health Issues. 2022 Nov-Dec;32(6):550-556. doi: 10.1016/j.whi.2022.06.010. Epub 2022 Aug 1.
PubMed 35927176Scroggins JK, Harkins SE, Brown S, St Clair V, LeBron GK, Barcelona V. A systematic review of community-based interventions to address perinatal mental health. Semin Perinatol. 2024 Oct;48(6):151945. doi: 10.1016/j.semperi.2024.151945. Epub 2024 Jul 14.
PubMed 39033052Haerizadeh-Yazdi N, Huynh MP, Narva A, Grasty A, Lemon M, Claxton N, Gillespie K, Kallem S. Philadelphia Department of Health Doula Support Program: Early Successes and Challenges of a Program Serving Birthing People Affected by Substance Use Disorder. Matern Child Health J. 2023 Dec;27(Suppl 1):52-57. doi: 10.1007/s10995-023-03803-4. Epub 2023 Nov 9.
PubMed 37943395Klaman SL, Isaacs K, Leopold A, Perpich J, Hayashi S, Vender J, Campopiano M, Jones HE. Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance. J Addict Med. 2017 May/Jun;11(3):178-190. doi: 10.1097/ADM.0000000000000308.
PubMed 28406856Schiff DM, Nielsen T, Terplan M, Hood M, Bernson D, Diop H, Bharel M, Wilens TE, LaRochelle M, Walley AY, Land T. Fatal and Nonfatal Overdose Among Pregnant and Postpartum Women in Massachusetts. Obstet Gynecol. 2018 Aug;132(2):466-474. doi: 10.1097/AOG.0000000000002734.
PubMed 29995730Quiray J, Richards E, Navarro-Aguirre Y, Glazer D, Adachi J, Trujillo E, Perera D, Garcia EP, Bhat A. The role of doulas in supporting perinatal mental health - a qualitative study. Front Psychiatry. 2024 Feb 29;15:1272513. doi: 10.3389/fpsyt.2024.1272513. eCollection 2024.
PubMed 38487585
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digitally Enhanced Model of Peer Doula Support for Substance Use Disorder and Peripartum Care
- ClinicalTrials.gov ID
- NCT07642947
- Acronym / sponsor ID
- EMBRACE / CTN-0157
- Conditions
- Perinatal Substance Use
- Keywords
- Peer Doula, Perinatal Substance Use Disorder, Digital Model of Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Participants Cohort 1 | – | Other: Digitally Enhanced Peer Doula Model of CarePatient Participants who have not yet been exposed to the peer doula model of care or have been exposed for less than 30 days |
| Patient Participants Cohort 2 | – | Other: Digitally Enhanced Peer Doula Model of CarePatient Participants who have been exposed to the peer doula model of care for at least 30 days |
| Site Staff Participants | – | –Site staff participants who have been exposed to the peer doula model of care at their clinical site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 18 years of age or older.
- Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:
- Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
- 18 years of age or older
- Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services
Key exclusion criteria (6 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally Enhanced Peer Doula Model of CareIn 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. | Other | Patient Participants Cohort 1, Patient Participants Cohort 2 |
Primary outcome
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.
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. .
4 secondary outcomes
Number of Prenatal Obstetric Visits
Time frame: 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
Engagement in substance use disorder (SUD) treatment
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BackgroundRuiz MG, Dronamraju R. Utilizing doula care to support substance use disorder in the postpartum period. Association of State and Territorial Health Officials,, 2023.
- Background: PubMed 39551148Gannon M, Hand D, Short VL, Carrubba T, Thiele G, Pancoe S, Lawson S, Haerizadeh-Yazdi N, Keith SW, Abatemarco D. "Someone is there with you through this [pregnancy] that isn't seeing you through a negative lens": Considerations for integrating doula referrals into opioid treatment programs. J Subst Use Addict Treat. 2025 Feb;169:209585. doi: 10.1016/j.josat.2024.209585. Epub 2024 Nov 17.
- Background: PubMed 27824771Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths From Suicide and Overdose in Colorado, 2004-2012. Obstet Gynecol. 2016 Dec;128(6):1233-1240. doi: 10.1097/AOG.0000000000001695.
- Background: PubMed 30091969Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1.
- Background: PubMed 33758116Nidey N, Kair LR, Wilder C, Froehlich TE, Weber S, Folger A, Marcotte M, Tabb K, Bowers K. Substance Use and Utilization of Prenatal and Postpartum Care. J Addict Med. 2022 Jan-Feb 01;16(1):84-92. doi: 10.1097/ADM.0000000000000843.
- Background: PubMed 37991773Han B, Compton WM, Einstein EB, Elder E, Volkow ND. Pregnancy and Postpartum Drug Overdose Deaths in the US Before and During the COVID-19 Pandemic. JAMA Psychiatry. 2024 Mar 1;81(3):270-283. doi: 10.1001/jamapsychiatry.2023.4523.
- Background: PubMed 37424702Mazel S, Alexander K, Cioffi C, Terplan M. Interventions to Support Engagement in Addiction Care Postpartum: Principles and Pitfalls. Subst Abuse Rehabil. 2023 Jul 3;14:49-59. doi: 10.2147/SAR.S375652. eCollection 2023.
- Background: PubMed 31173749Goldman-Mellor S, Margerison CE. Maternal drug-related death and suicide are leading causes of postpartum death in California. Am J Obstet Gynecol. 2019 Nov;221(5):489.e1-489.e9. doi: 10.1016/j.ajog.2019.05.045. Epub 2019 Jun 4.
- Background: PubMed 36472602Bruzelius E, Martins SS. US Trends in Drug Overdose Mortality Among Pregnant and Postpartum Persons, 2017-2020. JAMA. 2022 Dec 6;328(21):2159-2161. doi: 10.1001/jama.2022.17045.
- Background: PubMed 35927176Eliason EL, Gordon SH. The Association Between Postpartum Insurance Instability and Access to Postpartum Mental Health Services: Evidence From Colorado. Womens Health Issues. 2022 Nov-Dec;32(6):550-556. doi: 10.1016/j.whi.2022.06.010. Epub 2022 Aug 1.
- Background: PubMed 39033052Scroggins JK, Harkins SE, Brown S, St Clair V, LeBron GK, Barcelona V. A systematic review of community-based interventions to address perinatal mental health. Semin Perinatol. 2024 Oct;48(6):151945. doi: 10.1016/j.semperi.2024.151945. Epub 2024 Jul 14.
- Background: PubMed 37943395Haerizadeh-Yazdi N, Huynh MP, Narva A, Grasty A, Lemon M, Claxton N, Gillespie K, Kallem S. Philadelphia Department of Health Doula Support Program: Early Successes and Challenges of a Program Serving Birthing People Affected by Substance Use Disorder. Matern Child Health J. 2023 Dec;27(Suppl 1):52-57. doi: 10.1007/s10995-023-03803-4. Epub 2023 Nov 9.
- Individual participant dataSharing planned: Yes. De-identified participant level data will be posted to the NIDA data share website
Related trials for Perinatal Substance Use
Recruiting
Home Visitation Enhancing Linkages Project in Kansas
Substance Use
Recruiting
Screening & TReatment fOr Perinatal WomeN With PTSD in Substance Use Care SettinGs in Arkansas (STRONG Moms)
Written Exposure Therapy
Recruiting
Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
Substance Use Treatment, Perinatal Substance Use
Recruiting
Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
Perinatal Opioid Use Disorder, Opioid Use Disorder
Recruiting
Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum
Perinatal, Cannabis Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A. Marsch, PhD principal investigator
Dartmouth College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Substance Use, run by Trustees of Dartmouth College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Saunders, PhD (603-646-7006, Elizabeth.C.Saunders@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07642947, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.