ClinicalTrials.Veeva

Menu

The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Perinatal Mental Health

Treatments

Behavioral: Behavioral Treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06467916
23-1191
K08MH127519 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

Enrollment

72 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • NICU parents: Participants will be parents of currently hospitalized preterm infants from either the OHSU NICU or the UCH NICU. We will include parents of live preterm infants who have been admitted in the NICU for at least 2 weeks. Parents must speak English or Spanish. Parents can be of any age.
  • NICU stakeholders: Participants will be stakeholders from either the OHSU NICU or the UCH NICU. Stakeholders will be social workers, mental health providers responsible for providing more intensive mental health support for NICU parents, nurses, neonatologists, and hospital administrators.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Intervention
Experimental group
Description:
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Treatment:
Behavioral: Behavioral Treatment
Control
No Intervention group
Description:
usual care

Trial contacts and locations

2

Loading...

Central trial contact

Sunah S Hwang, MD, PhD, MPH/MSPH; Susanne Klawetter, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems