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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06467916
Status
Recruiting

Conditions

  • Perinatal Mental Health

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Treatment — BEHAVIORAL
    anticipatory guidance, brief behavioral intervention, or referral to community mental health provider

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
Apr 2025
Primary completion
Apr 1, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention
    anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
  • No Intervention: Control
    usual care

Primary Outcome Measure

Mental health self-efficacy scale [ Time Frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Susanne Klawetter, PhD
303-724-1646
Sunah S Hwang, MD, PhD, MPH/MSPH
720-848-0000
Oregon Health & Science UniversityPortlandOregon97239
Cindy McEvoy, MD,MCR
503-494-8122
Susanne Klawetter, PhD
303-724-1646

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