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Recruiting

NCT Number: NCT06467916

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

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.

Recruiting

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Key information

Conditions

Perinatal Mental Health Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Treatment

Behavioral

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

Primary outcomes

  1. Mental health self-efficacy scale

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    Mental health self-efficacy

Secondary outcomes

  1. City Mental Illness Stigma Scale

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    Mental illness stigma

  2. Parenting Sense of Self Confidence Scale

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    Parenting self-efficacy

Other outcomes

  1. Edinburgh Postnatal Depression Scale (EDPS)

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    Perinatal depression

  2. GAD-7

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    Anxiety

  3. Post-Traumatic Stress Disorder Questionnaire (PPQ)

    Time frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge

    PTSD

Study contacts

Contact information is provided by the study sponsor or research team.

Sunah S Hwang, MD, PhD, MPH/MSPH

CONTACT

[email protected]

720-848-0000

Susanne Klawetter, PhD

CONTACT

[email protected]

303-724-1646

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Oregon Health and Science University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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