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Clinical Trials/NCT06467916
NCT06467916RecruitingNot 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 enrollmentStarted: April 22, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
72
Locations
2
Primary Endpoint
Mental health self-efficacy scale

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None (Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Experimental

anticipatory guidance, brief behavioral intervention, or referral to community mental health provider

Intervention: Behavioral Treatment (Behavioral)

Control

No Intervention

usual care

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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