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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06467916
Enrollment
72
Registered
2024-06-21
Start date
2025-04-22
Completion date
2026-04-30
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Mental Health

Keywords

neonatal intensive care unit, perinatal mental health, perinatal depression, perinatal anxiety, posttraumatic stress disorder

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.

Interventions

BEHAVIORALBehavioral Treatment

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

Sponsors

Oregon Health and Science University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Mental health self-efficacy scale~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargeMental health self-efficacy

Secondary

MeasureTime frameDescription
City Mental Illness Stigma Scale~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargeMental illness stigma
Parenting Sense of Self Confidence Scale~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargeParenting self-efficacy

Other

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale (EDPS)~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargePerinatal depression
GAD-7~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargeAnxiety
Post-Traumatic Stress Disorder Questionnaire (PPQ)~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-dischargePTSD

Countries

United States

Contacts

Primary ContactSusanne Klawetter, PhD
susanne.klawetter@cuanschutz.edu303-724-1646
Backup ContactSunah S Hwang, MD, PhD, MPH/MSPH
sunah.hwang@childrenscolorado.org720-848-0000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026