Understanding the Role of Doulas in Supporting People With PMADs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Montana

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Behavioral

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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Standard Doula Care Plus the PMAD InterventionExperimental treatment 1 intervention
Group B: Standard Doula CareActive comparator 1 intervention
Group C: Standard Maternal CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At study enrollment
2

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.

Time frame
1-month postpartum
3

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.

Time frame
At 3-months
4

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.

Time frame
At 6-months postpartum.

Secondary outcomes

1

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.

Time frame
At study enrollment
2

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.

Time frame
At 1-month postpartum
3

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.

Time frame
3-months postpartum
4

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.

Time frame
At 6-months postpartum

Other outcomes

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