Back to resultsA Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
Primary Purpose
Depression, Postpartum, Efficacy, Self, Anxiety
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Promoting First Relationships-Brief
Perinatal Collaborative Care
Sponsored by
About this trial
This is an interventional health services research trial for Depression, Postpartum
Eligibility Criteria
Inclusion Criteria:
- English speaking pregnant women between gestational age (GA) 13 - 24 weeks
- ≥ 18 years,
- EPDS score ≥10,
- Ability to send and receive text messages (TM)
Exclusion Criteria:
- Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
- Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
- Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
- Multiple gestation (assessed by self-report and medical record);
- Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Maternal Infant Dyadic Care
Control
Arm Description
Perinatal collaborative care and Promoting First Relationships-Brief
Perinatal collaborative care only
Outcomes
Primary Outcome Measures
Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a ten-item self-report depression measure with higher scores indicating increased symptoms severity, total score ranging from 0 to 30 and is validated for use in the perinatal period.
Secondary Outcome Measures
Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)
The SENR contains 16 items rated on 7-point scales regarding mothers' perceptions of their competence on basic skills required in caring for an infant (e.g., "I feel confident in my role as a parent," "I can soothe my baby easily when he or she is crying or fussing") In the prenatal assessment questions address how women expect to do once their infant is born (e.g., "I look forward to becoming a parent with confidence in my role as a parent," "I expect to be able to soothe my baby easily when he or she is crying or fussing"). Scores on the SENR are obtained by summing individual items to yield a total efficacy score, with higher scores reflecting greater feelings of efficacy.
Change from Postpartum Baseline in Dyadic Interaction
Dyadic interaction will be coded using the NCAST applied to mother and child interactive behavior during a 3-minute videotaped session.
Change from Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
WHODAS 2.0 is a 12 item assessment of overall functioning. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed, total score ranging from 0 to 48.
Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)
The BIMF is a 20-item self-report measure for use in the first year postpartum and can assess overall functioning in the context of new motherhood. It measures the functional domains of social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). It is measured only postpartum. A total score is generated from summing the 20 items and ranges from 0 to 120.
Relative utilization of MInD vs usual CC
The investigators operationalize adequate treatment utilization as participating in a sufficient number of health care encounters to achieve a therapeutic effect: attendance at ≥6 care manager sessions (≥3 prenatal and ≥3 postpartum).
Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR)
The investigators will administer the Working Alliance Inventory (WAI-SR) to all enrolled women to assess strength of alliance with the therapist and compare mean change over time between MInD and usual CC groups.
Full Information
NCT ID
NCT04998721
First Posted
July 22, 2021
Last Updated
August 6, 2021
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04998721
Brief Title
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
Acronym
MInD
Official Title
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
Detailed Description
Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual perinatal collaborative care) or usual collaborative care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Efficacy, Self, Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maternal Infant Dyadic Care
Arm Type
Experimental
Arm Description
Perinatal collaborative care and Promoting First Relationships-Brief
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Perinatal collaborative care only
Intervention Type
Behavioral
Intervention Name(s)
Promoting First Relationships-Brief
Intervention Description
A brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum.
Intervention Type
Combination Product
Intervention Name(s)
Perinatal Collaborative Care
Intervention Description
Collaborative Care (CC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.
Primary Outcome Measure Information:
Title
Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)
Description
The EPDS is a ten-item self-report depression measure with higher scores indicating increased symptoms severity, total score ranging from 0 to 30 and is validated for use in the perinatal period.
Time Frame
Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Secondary Outcome Measure Information:
Title
Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)
Description
The SENR contains 16 items rated on 7-point scales regarding mothers' perceptions of their competence on basic skills required in caring for an infant (e.g., "I feel confident in my role as a parent," "I can soothe my baby easily when he or she is crying or fussing") In the prenatal assessment questions address how women expect to do once their infant is born (e.g., "I look forward to becoming a parent with confidence in my role as a parent," "I expect to be able to soothe my baby easily when he or she is crying or fussing"). Scores on the SENR are obtained by summing individual items to yield a total efficacy score, with higher scores reflecting greater feelings of efficacy.
Time Frame
Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Title
Change from Postpartum Baseline in Dyadic Interaction
Description
Dyadic interaction will be coded using the NCAST applied to mother and child interactive behavior during a 3-minute videotaped session.
Time Frame
6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Title
Change from Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Description
WHODAS 2.0 is a 12 item assessment of overall functioning. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed, total score ranging from 0 to 48.
Time Frame
Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Title
Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)
Description
The BIMF is a 20-item self-report measure for use in the first year postpartum and can assess overall functioning in the context of new motherhood. It measures the functional domains of social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). It is measured only postpartum. A total score is generated from summing the 20 items and ranges from 0 to 120.
Time Frame
6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Title
Relative utilization of MInD vs usual CC
Description
The investigators operationalize adequate treatment utilization as participating in a sufficient number of health care encounters to achieve a therapeutic effect: attendance at ≥6 care manager sessions (≥3 prenatal and ≥3 postpartum).
Time Frame
Baseline through up to 6 Months Postpartum (up to maximum of 9 months)
Title
Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR)
Description
The investigators will administer the Working Alliance Inventory (WAI-SR) to all enrolled women to assess strength of alliance with the therapist and compare mean change over time between MInD and usual CC groups.
Time Frame
30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking pregnant women between gestational age (GA) 13 - 24 weeks
≥ 18 years,
EPDS score ≥10,
Ability to send and receive text messages (TM)
Exclusion Criteria:
Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
Multiple gestation (assessed by self-report and medical record);
Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Franz, MPH
Phone
2062214549
Email
nfranz@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amritha S Bhat, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
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