Managing PPD at Gouverneur

Not Applicable

Withdrawn

• Conditions: Post-Partum Depression
• Interventions: Behavioral: STRONG

• Registration Number: NCT02738021
• Lead Sponsor: NYU Langone Health

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:

1. 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.

1. Train non specialty MH providers to systematically identify maternal depression.

2. Assess how effective integration of maternal depression intervention is as part of well baby visits.

2. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal Depression Management Inventory	One year	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.