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Clinical Trials/NCT06467916
NCT06467916
Recruiting
Not Applicable

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

University of Colorado, Denver2 sites in 1 country72 target enrollmentApril 22, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
University of Colorado, Denver
Enrollment
72
Locations
2
Primary Endpoint
Mental health self-efficacy scale
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2025
End Date
April 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mental health self-efficacy scale

Time Frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Mental health self-efficacy

Secondary Outcomes

  • City Mental Illness Stigma Scale(~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge)
  • Parenting Sense of Self Confidence Scale(~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge)

Study Sites (2)

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