Recruiting

Telehealth Program

Sponsor:

University of Colorado, Denver

Code:

NCT06467916

Conditions

Perinatal Mental Health

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Behavioral Treatment

Study Details

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 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.

Conditions

Perinatal Mental Health

Study ID

NCT06467916

Start date

Apr 22, 2025

Status verified date

Apr, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

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

no intervention: Control

usual care

Interventions

Behavioral Treatment

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

Primary outcome measure

  • Mental health self-efficacy scale [ Time Frame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge ]

Central Contacts and Locations

Central contacts

Susanne Klawetter, PhD

303-724-1646susanne.klawetter@cuanschutz.edu

Sunah S Hwang, MD, PhD, MPH/MSPH

720-848-0000sunah.hwang@childrenscolorado.org

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Susanne Klawetter, PhD

303-724-1646susanne.klawetter@cuanschutz.edu

Sunah S Hwang, MD, PhD, MPH/MSPH

720-848-0000sunah.hwang@childrenscolorado.org

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Cindy McEvoy, MD,MCR

503-494-8122mcevoyc@ohsu.edu

Susanne Klawetter, PhD

303-724-1646susanne.klawetter@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

  • neonatal intensive care unit
  • perinatal mental health
  • perinatal depression
  • perinatal anxiety
  • posttraumatic stress disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-24.