NCT06467916 The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
| NCT ID | NCT06467916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Perinatal Mental Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-04-22 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06467916 clinical trial?
This trial is open to participants of all sexes, studying Perinatal Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06467916 currently recruiting?
Yes, NCT06467916 is actively recruiting participants. Contact the research team at susanne.klawetter@cuanschutz.edu for enrollment information.
Where is the NCT06467916 trial being conducted?
This trial is being conducted at Aurora, United States, Portland, United States.
Who is sponsoring the NCT06467916 clinical trial?
NCT06467916 is sponsored by University of Colorado, Denver. The trial plans to enroll 72 participants.