Understanding the Role of Doulas in Supporting People With PMADs

Part of paid clinical trials in Missoula, Montana.

Sponsor
University of Montana
Study ID
NCT05763537
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standard Doula Care Plus PMAD Intervention — BEHAVIORAL
    Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.
  • Standard Doula Care — BEHAVIORAL
    Doulas trained in the DONA training will provide care to perinatal people.

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Standard Doula Care Plus the PMAD Intervention
    Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training in addition to PMAD-specific care from their doulas.
  • Active Comparator: Standard Doula Care
    Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training.
  • No Intervention: Standard Maternal Care
    In this arm participants will receive standard perinatal medical care and will not receive care from a doula.

Primary Outcome Measure

The Childbirth Self-Efficacy Inventory (CBSEI) [ Time Frame: At study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MontanaMissoulaMontana59812
Jessica L Liddell, PhD
[email protected]
435-757-6780

Find similar trials in Missoula, MT

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Montana· Missoula, MT

Related Studies