Understanding the Role of Doulas in Supporting People With PMADs

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance-Related Disorders; Depression; Postpartum Depression; Pregnancy; Maternal Health; Mental Health; Self Efficacy; Social Support; Delivery, Obstetric; Mental Health Services
• Intervention / Treatment: Behavioral: Standard Doula Care Plus PMAD Intervention; Behavioral: Standard Doula Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Standard Doula Care Plus PMAD Intervention; Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.
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.	Behavioral: Standard Doula Care; Doulas trained in the DONA training will provide care to perinatal people.
No Intervention: Standard Maternal Care; In this arm participants will receive standard perinatal medical care and will not receive care from a doula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)	The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.	At study enrollment
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)	The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.	At 1-month postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)	The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.	3-months postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)	The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.	At 6-months postpartum
Drug Abuse Screening Test (DAST)	The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.	At study enrollment
Change in the Drug Abuse Screening Test (DAST) at 1-month postpartum	The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.	At 1-month postpartum
Change in the Drug Abuse Screening Test (DAST) at 3-months postpartum	The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.	At 3-months postpartum
Change in the Drug Abuse Screening Test (DAST) at 6-months postpartum	The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.	At 6-months postpartum.
CDC Health-Related Quality of Life (HRQOL)- 4 scale	The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).	At study enrollment
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 1-month postpartum	The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).	At 1-month postpartum
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 3-months postpartum	The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).	At 3-months postpartum.
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 6-months postpartum	The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).	At 6-months postpartum
Pregnancy Risk Assessment Monitoring (PRAMS)	The core PRAMS questionnaire is a 52-item survey asking questions about behaviors and experiences during pregnancy, labor and the postpartum time period.	1 time during the study period, at 1-month postpartum.

Collaborators and Investigators

• Sponsor: University of Montana

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2024
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Substance-Related Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 162-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No