Actively Recruiting
The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
Led by University of Colorado, Denver · Updated on 2025-04-24
72
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing and testing a telehealth-based program called PATH to support the mental health of parents as their infants leave the neonatal intensive care unit (NICU) and transition home. This program focuses on screening parents for depression, anxiety, and post-traumatic stress disorder (PTSD) using a stepped-care approach. Its goal is to offer brief behavioral interventions for those at low risk and connect those at medium to high risk with community mental health services. The study compares two groups: one receiving the PATH intervention, which includes anticipatory guidance, brief behavioral treatment, or referral to community mental health providers, and a control group receiving usual care. Participants are randomized to either group. The program is delivered via telehealth during the transition period from hospital to home. Parents will be assessed using several scales measuring mental health self-efficacy, stigma related to mental illness, and parenting confidence at approximately two weeks before discharge, two weeks after discharge, and six weeks after discharge. The study monitors how well parents manage their mental health and parenting during this critical period. The total participation duration includes these key assessments in the weeks surrounding infant discharge from the NICU.
CONDITIONS
Brief Title
The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents of live preterm infants hospitalized in the NICU for at least 2 weeks
- Parents must speak English or Spanish
- Parents can be of any age
- NICU stakeholders including social workers, mental health providers, nurses, neonatologists, and hospital administrators from the OHSU or UCH NICUs
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From approximately 2 weeks prior to discharge to 6 weeks post-discharge
Participants receive behavioral treatment including anticipatory guidance, brief behavioral intervention, or referral to community mental health provider, or usual care.
3 visits (approximately 2 weeks prior to discharge, 2 weeks post-discharge, and 6 weeks post-discharge)
Trial Site Locations
Total: 2 locations
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
S
Susanne Klawetter, PhD
S
Sunah S Hwang, MD, PhD, MPH/MSPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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