Managing PPD at Gouverneur

NCT02738021 | Withdrawn

• 1 other identifier: 15-00416
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Train non specialty MH providers to systematically identify maternal depression.
3. 3.Assess how effective integration of maternal depression intervention is as part of well baby visits.
4. 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.

Conditions

Post-Partum Depression

Keywords

Psychosocial; Psychotherapy; Maternal

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  A validated 9-item self-administered version of the PRIME-MD that assesses depression severity.

  One year

Secondary Outcomes (1)

• Maternal Depression Management Inventory

  One year

Study Arms (1)

STRONG

EXPERIMENTAL

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

Behavioral: STRONG

Interventions

STRONG BEHAVIORAL

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

STRONG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Serene Olin, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12