The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
2 other identifiers
interventional
72
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedStudy Start
First participant enrolled
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedApril 24, 2025
April 1, 2025
11 months
June 14, 2024
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mental health self-efficacy scale
Mental health self-efficacy
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary Outcomes (2)
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
Other Outcomes (3)
Edinburgh Postnatal Depression Scale (EDPS)
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
GAD-7
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Post-Traumatic Stress Disorder Questionnaire (PPQ)
~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Study Arms (2)
Intervention
EXPERIMENTALanticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Control
NO INTERVENTIONusual care
Interventions
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Eligibility Criteria
You may qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Oregon Health and Science Universitycollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 21, 2024
Study Start
April 22, 2025
Primary Completion
April 1, 2026
Study Completion
April 30, 2026
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- All shareable, de-identified scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 3 years after the funding period.
- Access Criteria
- Scientific data will be findable for the research community through PubMed Central. For all publications, a digital object identifier (DOI) will be created. The data DOI will be referenced in the publication to allow the scientific community easy access to the data used in the publication.
Project data and materials will be administered in accordance with both participating institutional and NIH policies, including the NICH Data Sharing Policy and Implementation Guidance of March 5, 2003. Depending on such policies, materials may be transferred to others under the terms of material transfer agreement. Data, including survey instruments and datasets, will be available approximately one year after study completion. Researchers can contact the research staff to request access to datasets and support for their use. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. The final locked dataset will be stripped of all participant identifiers. This dataset will be available to the nonprofit community for noncommercial uses provided that a data-sharing agreement is reached and that the original creators of the dataset are able to collaborate in all secondary data analysis.