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 — BEHAVIORALanticipatory 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: Interventionanticipatory guidance, brief behavioral intervention, or referral to community mental health provider
- No Intervention: Controlusual 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
- Susanne Klawetter, PhD303-724-1646
- Sunah S Hwang, MD, PhD, MPH/MSPH720-848-0000
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | |
| Oregon Health & Science University | Portland | Oregon | 97239 |
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