What this study is
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.
What's being tested
- Standard Doula Care Plus PMAD Intervention
Intervention · BEHAVIORAL
Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.
- Standard Doula Care
Intervention · BEHAVIORAL
Doulas trained in the DONA training will provide care to perinatal people.
Study details
- Sponsor
- University of Montana
- Conditions
- Maternal Health · Pregnancy · Delivery, Obstetric · Self Efficacy · Social Support · Mental Health · Substance-Related Disorders · Postpartum Depression · Depression · Mental Health Services
- Enrolling
- 75 people
- Starts
- 2024-11-26
- Est. completion
- 2026-12-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Montana
Missoula, Montana, United States
- Jessica L Liddell, PhD · Contact4357576780jessica.liddell@mso.umt.edu
Recruiting
Study team
Sponsor
University of Montana
Study ID 162-22
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.