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Recruiting NCT06467916

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

No phase Interventional Perinatal Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Treatment.
Who it may be relevant to
Registry conditions: Perinatal Mental Health. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Mental health self-efficacy scale [Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge]
Secondary outcome measures (2)
  • City Mental Illness Stigma Scale [Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge]
  • Parenting Sense of Self Confidence Scale [Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • University of Colorado Hospital — Aurora
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT06467916 · 23-1191 · K08MH127519

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗