Understanding the Role of Doulas in Supporting People With PMADs

NCT05763537 | Recruiting DMC

• 1 other identifier: 162-22
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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; Mental Health; Substance-Related Disorders; Postpartum Depression; Depression; Mental Health Services

Outcome Measures

Primary Outcomes (38)

• The Childbirth Self-Efficacy Inventory (CBSEI)

  The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.

  At study enrollment

• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum

  The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.

  1-month postpartum

• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum

  The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.

  At 3-months

• Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum

  The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.

  At 6-months postpartum.

• The General Self-Efficacy Scale (SGSE)

  The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).

  At study enrollment

• Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum

  The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).

  1-month postpartum

• Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum

  The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).

  At 3-months postpartum

• Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum

  The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).

  At 6-months postpartum.

• Edinburgh Depression Scale

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).

  At study enrollment

• Change in the Edinburgh Depression Scale at 1-month postpartum

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).

  At 1-month postpartum

• Change in the Edinburgh Depression Scale at 3-months postpartum

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).

  At 3-months postpartum.

• Change in Edinburgh Depression Scale at 6-months postpartum

  The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).

  At 6-months postpartum.

• Patient Health Questionnaire (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).

  At study enrollment

• Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).

  At 1-month postpartum

• Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).

  At 3-months postpartum.

• Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).

  At 6-months postpartum.

• Generalized Anxiety Disorder (GAD)-7

  The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."

  At study enrollment

• Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum

  The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."

  At 1-month postpartum

• Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum

  The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."

  At 3-months postpartum.

• Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum

  The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."

  At 6-months postpartum.

• Multi-Dimensional Scale of Perceived Social Support (MSPSS)

  The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).

  At study enrollment

• Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum

  The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).

  At 1-month postpartum

• Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum

  The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).

  At 3-months postpartum.

• Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum

  The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).

  At 6-months postpartum.

• Social Support Questionnaire (SSQ)- Short Form

  The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).

  At study enrollment

• Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum

  The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).

  At 1-month postpartum

• Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum

  The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).

  At 3-months postpartum.

• Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum

  The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).

  At 6-months postpartum.

• Birth Companion Support Questionnaire

  The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).

  1-month postpartum

• Change in Birth Companion Support Questionnaire at 3-months postpartum

  The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).

  At 3-months

• Change in Birth Companion Support Questionnaire at 6-months postpartum

  The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).

  At 6-months postpartum

• The Perceived Wellness Scale

  The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).

  At study enrollment

• Change in the Perceived Wellness Scale at 1-month postpartum

  The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).

  1-month postpartum

• Change in the Perceived Wellness Scale at 3-months postpartum

  The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).

  3-months postpartum

• Change in the Perceived Wellness Scale at 6-months postpartum

  The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).

  At 6-months postpartum.

• City Birth Trauma Scale City Birth Trauma Scale

  The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).

  At 1-month postpartum

• Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale

  The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).

  At 3-months postpartum

• Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale

  The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).

  At 6-months postpartum

Secondary Outcomes (13)

• Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)

  At study enrollment

• Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)

  At 1-month postpartum

• Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)

  3-months postpartum

• Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)

  At 6-months postpartum

• Drug Abuse Screening Test (DAST)

  At study enrollment

Study Arms (3)

Standard Doula Care Plus the PMAD Intervention

EXPERIMENTAL

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.

Behavioral: Standard Doula Care Plus PMAD Intervention

Standard Doula Care

ACTIVE COMPARATOR

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

Behavioral: Standard Doula Care

Standard Maternal Care

NO INTERVENTION

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 BEHAVIORAL

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

Standard Doula Care Plus the PMAD Intervention

Standard Doula Care BEHAVIORAL

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

Standard Doula Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• University of Montana: lead

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders; Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Behavioral Symptoms

Central Study Contacts

Jessica L Liddell, PhD

CONTACT

4357576780; jessica.liddell@mso.umt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 10, 2023
• Study Start: November 26, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-06

Locations

US (1)