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Understanding the Role of Doulas in Supporting People With PMADs

NCT ID: NCT05763537

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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. A subsection of 20 participants who receive care from doulas in the PMAD training will also be eligible to participate in a qualitative interview at 6 months postpartum. The interview guide will be developed based on prior research with doulas, the PI's current research exploring doula-care in Montana, and feedback from the CAB. Example questions are expected to include: "What were your experiences working with a doula?" "What would have made your experience better?" and "What worked and what didn't work?"

Interviewers will all be graduate students who have completed research methods courses and will be trained by the PI, who has extensive experience in conducting qualitative research and in conducting qualitative interviews.

The following procedures will be followed:

1. Once participants have indicated that they are interested in participating in the study, the PI will contact them to set up a time to discuss the study with them, and if they are interested and meet eligibility criteria, enroll them in the study. Participants will be randomly assigned to either receive standard care from a doula, the doula PMAD intervention, or perinatal care as usual.
2. Before enrollment in the study, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants.
3. Once the participants have provided informed consent, they will be given the pre-test survey via REDCap and will take the survey again at 1 month postpartum and 3 months postpartum.
4. All participants will be connected to a doula and receive either care as usual from a doula or a doula trained in the intervention by the PI and will engage in care with them throughout their pregnancy, during childbirth, and for 3 months postpartum. The exact components of the doula care provided will be developed in aim 2 based on the findings of study 1.
5. Participants will be provided compensation (in the form of a gift card) after the completion of each survey (pre-test, 1 month postpartum, 3 and 6 months postpartum).
6. At the completion of the study, participants will be thanked for their time and participation. For those who agreed to do member checks, participants will be re-contacted after analysis for member checks.

Participants who are randomized into the intervention arm of the study will also be randomly selected to participate in cross-sectional, semi-structured interviews.

Participant recruitment is described in the recruitment and retention plan. Participants will be interviewed about experience in the intervention.

The following steps will be followed:

1. Once participants have indicated that they are interested in participating in the interview portion of the study, the PI will contact them to set up a time for an interview and about their preferred interview site. They will have the option to do a phone interview if they are not available for an in-person interview or if they are not comfortable with an in-person interview for privacy reasons. The first interview will take place before they begin care with their doula.
2. Interview sessions will be scheduled at a pre-determined time at locations desired by the participants. If the interview takes place in person, Covid-19 protocols will be followed and include the completion of a Covid-19 symptom questionnaire by both the participant and the interviewer, the wearing of face masks during the interview, and social distancing.
3. Before beginning the interview, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants. This process is further described in the Protection of Human Subjects document.
4. Once the participants have provided informed consent and provided consent to having the interview audio-recorded, the interviewer will begin recording the interview. A semi-structured interview guide will be used to guide the interview.
5. Audio-recorded interviews will follow semi-structured interview guides and last 60-90 minutes.
6. Following the interview, participants will be asked whether they are willing to be contacted to do a follow-up interview at 3 months postpartum.
7. Participants will be provided their compensation.
8. Participants will be thanked for their time and participation.
9. For those who agreed to do a second and third interviews at 3 and 6 months postpartum, the same process will be followed to conduct their second interview.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Standard Doula Care Plus PMAD Intervention

Intervention Type BEHAVIORAL

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

Standard Doula Care

Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training.

Group Type ACTIVE_COMPARATOR

Standard Doula Care

Intervention Type BEHAVIORAL

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

Standard Maternal Care

In this arm participants will receive standard perinatal medical care and will not receive care from a doula.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard Doula Care Plus PMAD Intervention

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

Intervention Type BEHAVIORAL

Standard Doula Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Montana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Montana

Missoula, Montana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica L Liddell, PhD

Role: CONTACT

Phone: 4357576780

Email: [email protected]

Facility Contacts

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Jessica L Liddell, PhD

Role: primary

Other Identifiers

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162-22

Identifier Type: -

Identifier Source: org_study_id