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Behavioral Intervention

PATH Program for NICU Parent Mental Health

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Awards & highlights

Summary

"This trial aims to create and test a telehealth program to help parents transitioning from the NICU to home. The program will screen parents for mental health issues like depression, anxiety, and PTSD, provide

Who is the study for?
This trial is for parents transitioning from the Neonatal Intensive Care Unit (NICU) to home, who may be at risk of depression, anxiety, or PTSD. It's designed to help those with at least a low risk of these conditions and provide further support for those with medium to high risk.
What is being tested?
The PATH program being tested offers telehealth-based mental health screening and engagement. It includes a brief behavioral intervention and connects parents at higher risk with community mental health services.
What are the potential side effects?
Since PATH is a mental health support program rather than a medication, it does not have traditional side effects. However, discussing emotional issues can sometimes temporarily increase distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental health self-efficacy scale
Secondary outcome measures
City Mental Illness Stigma Scale
Parenting Sense of Self Confidence Scale
Other outcome measures
Edinburgh Postnatal Depression Scale (EDPS)
GAD-7
Post-Traumatic Stress Disorder Questionnaire (PPQ)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
anticipatory guidance, brief behavioral intervention, or referral to community mental health provider
Group II: ControlActive Control1 Intervention
usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PATH
2006
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,878 Total Patients Enrolled
2 Trials studying Postpartum Depression
556 Patients Enrolled for Postpartum Depression
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,538 Total Patients Enrolled
2 Trials studying Postpartum Depression
1,250 Patients Enrolled for Postpartum Depression
~47 spots leftby Apr 2026
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