Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder (NCT07642947) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder
United States100 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Intervention Measure (FIM)
Timeframe: At enrollment
2
Acceptability of Intervention Measures (AIM)
Timeframe: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)
. 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
. 18 years of age or older
. Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services
. 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