Managing PPD at Gouverneur

Post-Partum Depression Clinical Trial

Official title:

Stepped Care for Postpartum Depression in Pediatric Primary Care: A Pilot Project at Gouverneur Health Services

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02738021
• Other study ID #: 15-00416
• Status: Withdrawn
• Phase: N/A
• First received: April 8, 2016
• Last updated: December 4, 2017
• Start date: March 1, 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-Partum Depression

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	A validated 9-item self-administered version of the PRIME-MD that assesses depression severity.	One year
Secondary	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.	One year