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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467916
• Other study ID #: K08MH127519
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2024
• Source: University of Colorado, Denver
• Contact: Susanne Klawetter, PhD
• Phone: 303-724-1646
• Email: susanne.klawetter[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as they transition from the NICU to home. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 born less than or equal to 32 weeks gestational age. Infants must be 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, and neonatologists.

Related Conditions & MeSH terms

• Perinatal Anxiety
• Perinatal Depression
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh Postnatal Depression Scale (EDPS)	Perinatal depression	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Other	GAD-7	Anxiety	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Other	Post-Traumatic Stress Disorder Questionnaire (PPQ)	PTSD	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Primary	Mental health self-efficacy scale	Mental health self-efficacy	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary	City Mental Illness Stigma Scale	Mental illness stigma	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary	Parenting Sense of Self Confidence Scale	Parenting self-efficacy	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge