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Clinical trial Recruiting at 2 sites Interventional

A program to support NICU parents' mental health during their transition home

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

Run by University of Colorado, Denver · NCT06467916 · Data updated 2026-11-12

This study is testing a new telehealth program to help parents of preterm infants coming home from the NICU by supporting their mental health and connecting them to resources if they need extra help.

Quick facts

Study typeInterventional
SexAll
Enrollment72 (estimated)
SponsorUniversity of Colorado, Denver
Academic / other
Locations2 sites (Aurora, Colorado and 1 other locations)
StatusRecruiting
StartedApril 22, 2025
Main results expectedApril 1, 2026
Study endsApril 30, 2026
Registry record updatedApril 24, 2025
Trial IDNCT06467916 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are parents of preterm infants currently hospitalized in the NICU who can communicate in English or Spanish.

Probably not a fit

Patients who do not have a preterm infant in the NICU or those who are not fluent in English or Spanish may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and pilot a telehealth-based program designed to support the mental health of parents whose infants are transitioning from the neonatal intensive care unit (NICU) to home. It employs a stepped-care approach to screen parents for conditions such as depression, anxiety, and PTSD, offering brief behavioral interventions for those at low risk and facilitating connections to community mental health services for those at medium to high risk. The program targets parents of preterm infants who have been hospitalized in the NICU for at least two weeks.

Why it matters

Potential benefit: If successful, this program could significantly improve the mental health outcomes of NICU parents during a critical transition period.

How similar studies have gone: Other studies have shown success with telehealth interventions for mental health support, indicating that this approach is promising and not entirely novel.

Who can join: the full rules

Show full inclusion / 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.

Where it's running

  • University of Colorado Hospital
    Aurora, Colorado, United States     Recruiting
  • Oregon Health & Science University
    Portland, Oregon, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Perinatal Mental Health 8University of Colorado Denver 1741
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.