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Managing PPD at Gouverneur

Primary Purpose

Post-Partum Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STRONG
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Partum Depression focused on measuring Psychosocial, Psychotherapy, Maternal

Eligibility Criteria

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

Inclusion Criteria for Subjects

  • PHQ-9 scores in the 10-19 range
  • Women with infants 6 months and younger at time of screening

Inclusion Criteria for Providers

Exclusion Criteria:

  • Active substance use
  • Current treatment for depression
  • Current/past history of schizophrenia, bipolar or other psychotic disorder;
  • Suicidal/Homicidal risks;
  • Women with difficulties speaking or understanding English;
  • Women under the age of 18.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    STRONG

    Arm Description

    A brief 3-session IPT-based preventive intervention, on maternal and child health outcomes.

    Outcomes

    Primary Outcome Measures

    Patient Health Questionnaire-9 (PHQ-9)
    A validated 9-item self-administered version of the PRIME-MD that assesses depression severity.

    Secondary Outcome Measures

    Maternal Depression Management Inventory
    It is a fifty-nine (59) item survey of primary care provider beliefs, attitudes and practices related to the assessment and management of maternal depression.

    Full Information

    First Posted
    April 8, 2016
    Last Updated
    December 4, 2017
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02738021
    Brief Title
    Managing PPD at Gouverneur
    Official Title
    Stepped Care for Postpartum Depression in Pediatric Primary Care: A Pilot Project at Gouverneur Health Services
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care settings will be used to (1) understand context for implementation feasibility (2) evaluate benefits for mother and child. The proposed pilot project will be conducted as part of a quality improvement effort in the Department of Pediatrics at Gouverneur Health Services to improve management of postpartum depression during pediatric primary care visits. This project will test the feasibility of a stepped care approach to identifying and managing depression among mothers of infants (0-6 months). This study will provide preliminary data on the feasibility of the care management protocol, implementation and fidelity measures, and training/consultation methods within a real world pediatric care practice. These data will inform and support the preparation of a large-scale NIH grant. Specific research questions include: To pilot the feasibility of using a Stepped Care Approach to identify and mange maternal depression within primary care pediatric care visits, with a focus on mothers of infants 0-6 months. Train non specialty MH providers to systematically identify maternal depression. Assess how effective integration of maternal depression intervention is as part of well baby visits. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention, on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt of acute care services). Secondary outcomes include maternal social support and parenting practices.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Partum Depression
    Keywords
    Psychosocial, Psychotherapy, Maternal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    STRONG
    Arm Type
    Experimental
    Arm Description
    A brief 3-session IPT-based preventive intervention, on maternal and child health outcomes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    STRONG
    Intervention Description
    A brief 3-session IPT-based preventive intervention, on maternal and child health outcomes.
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    A validated 9-item self-administered version of the PRIME-MD that assesses depression severity.
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Maternal Depression Management Inventory
    Description
    It is a fifty-nine (59) item survey of primary care provider beliefs, attitudes and practices related to the assessment and management of maternal depression.
    Time Frame
    One year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria for Subjects PHQ-9 scores in the 10-19 range Women with infants 6 months and younger at time of screening Inclusion Criteria for Providers Exclusion Criteria: Active substance use Current treatment for depression Current/past history of schizophrenia, bipolar or other psychotic disorder; Suicidal/Homicidal risks; Women with difficulties speaking or understanding English; Women under the age of 18.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Serene Olin, PhD
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Managing PPD at Gouverneur

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