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A 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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression, Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 22, 2021
    Last Updated
    August 6, 2021
    Sponsor
    University of Washington
    Collaborators
    National Institute of Mental Health (NIMH)
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    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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