Managing PPD at Gouverneur
Primary Purpose
Post-Partum Depression
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STRONG
Sponsored by
About this trial
This is an interventional treatment trial for Post-Partum Depression focused on measuring Psychosocial, Psychotherapy, Maternal
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.
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
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Withdrawn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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