Clinical trial NCT05763537: Understanding the Role of Doulas in Supporting People With PMADs
Official title: Understanding the Role of Doulas in Supporting People With PMADs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Health
Pregnancy
Delivery, Obstetric
Self Efficacy
Social Support
Mental Health
Substance-Related Disorders
Postpartum Depression
Depression
Mental Health Services
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Childbirth Self-Efficacy Inventory (CBSEI)
timeFrame: At study enrollment
measure: Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum
timeFrame: 1-month postpartum
measure: Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum
timeFrame: At 3-months
measure: Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum
timeFrame: At 6-months postpartum.
measure: The General Self-Efficacy Scale (SGSE)
timeFrame: At study enrollment
measure: Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum
timeFrame: 1-month postpartum
measure: Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum
timeFrame: At 3-months postpartum
measure: Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: Edinburgh Depression Scale
timeFrame: At study enrollment
measure: Change in the Edinburgh Depression Scale at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in the Edinburgh Depression Scale at 3-months postpartum
timeFrame: At 3-months postpartum.
measure: Change in Edinburgh Depression Scale at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: At study enrollment
measure: Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9
timeFrame: At 1-month postpartum
measure: Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9
timeFrame: At 3-months postpartum.
measure: Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9
timeFrame: At 6-months postpartum.
measure: Generalized Anxiety Disorder (GAD)-7
timeFrame: At study enrollment
measure: Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum
timeFrame: At 3-months postpartum.
measure: Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum
timeFrame: At 6-months postpartum.
measure: Multi-Dimensional Scale of Perceived Social Support (MSPSS)
timeFrame: At study enrollment
measure: Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum
timeFrame: At 3-months postpartum.
measure: Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: Social Support Questionnaire (SSQ)- Short Form
timeFrame: At study enrollment
measure: Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum
timeFrame: At 3-months postpartum.
measure: Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: Birth Companion Support Questionnaire
timeFrame: 1-month postpartum
measure: Change in Birth Companion Support Questionnaire at 3-months postpartum
timeFrame: At 3-months
measure: Change in Birth Companion Support Questionnaire at 6-months postpartum
timeFrame: At 6-months postpartum
measure: The Perceived Wellness Scale
timeFrame: At study enrollment
measure: Change in the Perceived Wellness Scale at 1-month postpartum
timeFrame: 1-month postpartum
measure: Change in the Perceived Wellness Scale at 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in the Perceived Wellness Scale at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: City Birth Trauma Scale City Birth Trauma Scale
timeFrame: At 1-month postpartum
measure: Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale
timeFrame: At 3-months postpartum
measure: Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale
timeFrame: At 6-months postpartum
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: At study enrollment
measure: Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: At 1-month postpartum
measure: Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 3-months postpartum
measure: Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: At 6-months postpartum
measure: Drug Abuse Screening Test (DAST)
timeFrame: At study enrollment
measure: Change in the Drug Abuse Screening Test (DAST) at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in the Drug Abuse Screening Test (DAST) at 3-months postpartum
timeFrame: At 3-months postpartum
measure: Change in the Drug Abuse Screening Test (DAST) at 6-months postpartum
timeFrame: At 6-months postpartum.
measure: CDC Health-Related Quality of Life (HRQOL)- 4 scale
timeFrame: At study enrollment
measure: Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 1-month postpartum
timeFrame: At 1-month postpartum
measure: Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 3-months postpartum
timeFrame: At 3-months postpartum.
measure: Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 6-months postpartum
timeFrame: At 6-months postpartum
measure: Pregnancy Risk Assessment Monitoring (PRAMS)
timeFrame: 1 time during the study period, at 1-month postpartum.
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
References: