A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
NCT ID: NCT04998721
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2022-11-01
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Maternal Infant Dyadic Care
Perinatal collaborative care and Promoting First Relationships-Brief
Promoting First Relationships-Brief
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.
Perinatal Collaborative Care
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.
Control
Perinatal collaborative care only
Perinatal Collaborative Care
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.
Interventions
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Promoting First Relationships-Brief
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.
Perinatal Collaborative Care
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years,
* EPDS score ≥10,
* Ability to send and receive text messages (TM)
Exclusion Criteria
* 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).
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Amritha Subray Bhat
Assistant Professor, School of Medicine: Psychiatry
Principal Investigators
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Amritha S Bhat, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Amritha Bhat
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Amritha Bhat
Role: primary
Other Identifiers
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STUDY00011405
Identifier Type: -
Identifier Source: org_study_id