Managing PPD at Gouverneur

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02738021
Collaborator
(none)
0
1
19

Study Details

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:
  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.

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

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

  4. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STRONG
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stepped Care for Postpartum Depression in Pediatric Primary Care: A Pilot Project at Gouverneur Health Services
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: STRONG

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Serene Olin, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02738021
Other Study ID Numbers:
  • 15-00416
First Posted:
Apr 14, 2016
Last Update Posted:
Dec 6, 2017
Last Verified:
Dec 1, 2017
Keywords provided by NYU Langone Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2017