Recruiting

Understanding the Role of Doulas in Supporting People With PMADs

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following…

ClinicalTrials.gov IDNCT05763537
PhaseNA
Enrollment75
SponsorUniversity of Montana
Age18 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Maternal Health, Pregnancy, Delivery, Obstetric, Self Efficacy, Social Support, Mental Health, Substance-Related Disorders, Postpartum Depression, Depression, Mental Health Services

About this study

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Participants must be over the age of 18 * Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment * Live in a HRSA-designated rural area of Montana Exclusion Criteria: * They are under the age of 18 * Not currently pregnant * Not between 13-26 gestational weeks at the time of enrollment * If they do not live in a HRSA-designated rural are of Montana.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.