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

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 Overview

• Status: Recruiting
• Conditions: Perinatal Mental Health
• Intervention / Treatment: Behavioral: Behavioral Treatment

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Klawetter, PhD; Phone Number: 303-724-1646; Email: susanne.klawetter@cuanschutz.edu
• Study Contact Backup: Name: Sunah S Hwang, MD, PhD, MPH/MSPH; Phone Number: 720-848-0000; Email: sunah.hwang@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Susanne Klawetter, PhD; Phone Number: 303-724-1646; Email: susanne.klawetter@cuanschutz.edu
      • Contact: Sunah S Hwang, MD, PhD, MPH/MSPH; Phone Number: 720-848-0000; Email: sunah.hwang@childrenscolorado.org
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Susanne Klawetter, PhD; Phone Number: 303-724-1646; Email: susanne.klawetter@cuanschutz.edu
      • Contact: Cindy McEvoy, MD,MCR; Phone Number: 503-494-8122; Email: mcevoyc@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; usual care
Experimental: Intervention; anticipatory guidance, brief behavioral intervention, or referral to community mental health provider	Behavioral: Behavioral Treatment; anticipatory guidance, brief behavioral intervention, or referral to community mental health provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health self-efficacy scale	Mental health self-efficacy	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
City Mental Illness Stigma Scale	Mental illness stigma	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Parenting Sense of Self Confidence Scale	Parenting self-efficacy	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EDPS)	Perinatal depression	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
GAD-7	Anxiety	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Post-Traumatic Stress Disorder Questionnaire (PPQ)	PTSD	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Mental Health (NIMH); Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: neonatal intensive care unit; perinatal depression; posttraumatic stress disorder; perinatal mental health; perinatal anxiety
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 23-1191; K08MH127519 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No