Recruiting

Observational Study

Sponsor:

University of Montana

Code:

NCT05763537

Conditions

Maternal Health

Pregnancy

Delivery, Obstetric

Self Efficacy

Social Support

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard Doula Care Plus PMAD Intervention

Standard Doula Care

Study Details

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.

Conditions

Maternal Health

Pregnancy

Delivery, Obstetric

Self Efficacy

Social Support

Study ID

NCT05763537

Start date

Nov 26, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Standard Doula Care Plus PMAD Intervention

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

Standard Doula Care

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

Primary outcome measure

  • The Childbirth Self-Efficacy Inventory (CBSEI) [ Time Frame: At study enrollment ]
  • Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum [ Time Frame: 1-month postpartum ]
  • Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum [ Time Frame: At 3-months ]
  • Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum [ Time Frame: At 6-months postpartum. ]
  • The General Self-Efficacy Scale (SGSE) [ Time Frame: At study enrollment ]
  • Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum [ Time Frame: 1-month postpartum ]
  • Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum [ Time Frame: At 3-months postpartum ]
  • Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum [ Time Frame: At 6-months postpartum. ]
  • Edinburgh Depression Scale [ Time Frame: At study enrollment ]
  • Change in the Edinburgh Depression Scale at 1-month postpartum [ Time Frame: At 1-month postpartum ]
  • Change in the Edinburgh Depression Scale at 3-months postpartum [ Time Frame: At 3-months postpartum. ]
  • Change in Edinburgh Depression Scale at 6-months postpartum [ Time Frame: At 6-months postpartum. ]
  • Patient Health Questionnaire (PHQ)-9 [ Time Frame: At study enrollment ]
  • Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9 [ Time Frame: At 1-month postpartum ]
  • Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9 [ Time Frame: At 3-months postpartum. ]
  • Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9 [ Time Frame: At 6-months postpartum. ]
  • Generalized Anxiety Disorder (GAD)-7 [ Time Frame: At study enrollment ]
  • Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum [ Time Frame: At 1-month postpartum ]
  • Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum [ Time Frame: At 3-months postpartum. ]
  • Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum [ Time Frame: At 6-months postpartum. ]
  • Multi-Dimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: At study enrollment ]
  • Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum [ Time Frame: At 1-month postpartum ]
  • Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum [ Time Frame: At 3-months postpartum. ]
  • Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum [ Time Frame: At 6-months postpartum. ]
  • Social Support Questionnaire (SSQ)- Short Form [ Time Frame: At study enrollment ]
  • Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum [ Time Frame: At 1-month postpartum ]
  • Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum [ Time Frame: At 3-months postpartum. ]
  • Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum [ Time Frame: At 6-months postpartum. ]
  • Birth Companion Support Questionnaire [ Time Frame: 1-month postpartum ]
  • Change in Birth Companion Support Questionnaire at 3-months postpartum [ Time Frame: At 3-months ]
  • Change in Birth Companion Support Questionnaire at 6-months postpartum [ Time Frame: At 6-months postpartum ]
  • The Perceived Wellness Scale [ Time Frame: At study enrollment ]
  • Change in the Perceived Wellness Scale at 1-month postpartum [ Time Frame: 1-month postpartum ]
  • Change in the Perceived Wellness Scale at 3-months postpartum [ Time Frame: 3-months postpartum ]
  • Change in the Perceived Wellness Scale at 6-months postpartum [ Time Frame: At 6-months postpartum. ]
  • City Birth Trauma Scale City Birth Trauma Scale [ Time Frame: At 1-month postpartum ]
  • Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale [ Time Frame: At 3-months postpartum ]
  • Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale [ Time Frame: At 6-months postpartum ]

Central Contacts and Locations

Central contacts

Jessica L Liddell, PhD

4357576780jessica.liddell@mso.umt.edu

Locations

University of Montana

Recruiting

Missoula, Montana, United States, 59812

Contacts

Jessica L Liddell, PhD

4357576780jessica.liddell@mso.umt.edu

More Information

Sponsor

University of Montana

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Montana on 2026-08-14.