RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-22
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06467916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Susanne Klawetter, PhD
CONTACT
303-724-1646
susanne.klawetter@cuanschutz.edu
Sunah S Hwang, MD, PhD, MPH/MSPH
CONTACT
720-848-0000
sunah.hwang@childrenscolorado.org

Study Locations (Sites)

University of Colorado Hospital
Aurora, Colorado, 80045
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-22
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-04-22
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • neonatal intensive care unit
  • perinatal mental health
  • perinatal depression
  • perinatal anxiety
  • posttraumatic stress disorder

Additional Relevant MeSH Terms

  • Perinatal Mental Health