GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Public ClinicalTrials.gov record NCT02643472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available. OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status. METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months. PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status. ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
Study identification
- NCT ID
- NCT02643472
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2015
- Primary completion
- Jan 31, 2017
- Completion
- Feb 28, 2018
- Last update posted
- Aug 4, 2019
2016 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02643472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02643472 live on ClinicalTrials.gov.