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

Not Applicable

Not yet recruiting

• Conditions: Post Traumatic Stress Disorder; Perinatal Depression; Perinatal Anxiety
• Interventions: Behavioral: PATH

• Registration Number: NCT06467916
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Study Start: 2025-02-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	PATH	anticipatory guidance, brief behavioral intervention, or referral to community mental health provider

Primary Outcome Measures

Name	Time	Method
Mental health self-efficacy scale	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge	Mental health self-efficacy

Secondary Outcome Measures

Name	Time	Method
City Mental Illness Stigma Scale	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge	Mental illness stigma
Parenting Sense of Self Confidence Scale	~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge	Parenting self-efficacy

Trial Locations

Locations (2)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States