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

NCT ID: NCT06467916

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Perinatal Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Behavioral Treatment

Intervention Type BEHAVIORAL

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

Control

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral Treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susanne Klawetter, PhD

Role: CONTACT

303-724-1646

Sunah S Hwang, MD, PhD, MPH/MSPH

Role: CONTACT

720-848-0000

Facility Contacts

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Susanne Klawetter, PhD

Role: primary

303-724-1646

Sunah S Hwang, MD, PhD, MPH/MSPH

Role: backup

720-848-0000

Cindy McEvoy, MD,MCR

Role: primary

503-494-8122

Susanne Klawetter, PhD

Role: backup

303-724-1646

Other Identifiers

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K08MH127519

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1191

Identifier Type: -

Identifier Source: org_study_id

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