RecruitingNot ApplicableNCT05763537

Understanding the Role of Doulas in Supporting People With PMADs


Sponsor

University of Montana

Enrollment

75 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how doulas (trained non-medical birth and emotional support companions) can support pregnant people experiencing perinatal mood and anxiety disorders (PMADs) — such as depression or anxiety during pregnancy. This research focuses specifically on rural communities in Montana. **You may be eligible if...** - You are over 18 years old - You are currently pregnant and between 13 and 26 weeks along - You live in a rural area of Montana that is designated as underserved by HRSA **You may NOT be eligible if...** - You are under 18 - You are not currently pregnant - You are not in the 13–26 week gestational window at enrollment - You do not live in an eligible rural area of Montana Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStandard Doula Care Plus PMAD Intervention

Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.

BEHAVIORALStandard Doula Care

Doulas trained in the DONA training will provide care to perinatal people.


Locations(1)

University of Montana

Missoula, Montana, United States

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NCT05763537


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