PATH Program for NICU Parent Mental Health

Recruiting at 1 trial location

Overseen By Sunah S Hwang, MD, PhD, MPH/MSPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English/Spanish speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PATH treatment for NICU parent mental health?

The Giving Parents Support Study suggests that interventions like parent navigation can reduce stress and anxiety in parents after NICU discharge, which may support the effectiveness of the PATH treatment in improving mental health for NICU parents. ^{1 2 3 4 5}

Is the PATH Program for NICU Parent Mental Health safe for participants?

The available research does not provide specific safety data for the PATH Program or its variations like MATCH or PATH 2.0. However, the studies focus on mental health support for parents in the NICU, which generally involves non-invasive interventions like peer support and mental health screenings, suggesting a low risk of harm. ^{1 4 6 7 8}

How is the PATH treatment for NICU parent mental health different from other treatments?

The PATH treatment is unique because it focuses on providing comprehensive emotional support and education to NICU parents, involving mental health professionals from the antepartum period through after discharge, and emphasizes peer-to-peer support and psychotherapy within the NICU setting. ^{3 9 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for parents transitioning from the Neonatal Intensive Care Unit (NICU) to home, who may be at risk of depression, anxiety, or PTSD. It's designed to help those with at least a low risk of these conditions and provide further support for those with medium to high risk.

Inclusion Criteria

NICU stakeholders: Participants will be stakeholders from either the OHSU NICU or the UCH NICU. Stakeholders will include social workers, mental health providers responsible for providing more intensive mental health support for NICU parents, nurses, and neonatologists.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Telehealth screening

Intervention

Telehealth-based mental health screening and engagement program using a stepped-care approach

2 weeks post-discharge

Telehealth sessions

Follow-up

Participants are monitored for mental health outcomes and engagement with community services

6 weeks post-discharge

Telehealth follow-up

Treatment Details

Interventions

• PATH

Trial Overview The PATH program being tested offers telehealth-based mental health screening and engagement. It includes a brief behavioral intervention and connects parents at higher risk with community mental health services.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

usual care

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Giving Parents Support Study: A randomized clinical trial of a parent navigator intervention to improve outcomes after neonatal intensive care unit discharge. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing parental trauma and stress in neonatal intensive care: systematic review and meta-analysis of hospital interventions. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Infant-Family Mental Health in the NICU: A Mixed-Methods Study Exploring Referral Pathways and Family Engagement. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Implementing a standardized screening protocol for parental depression, anxiety, and PTSD symptoms in the Neonatal Intensive Care Unit. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Maternal and Paternal Depression Symptoms During NICU Stay and Transition Home. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

NICU infant health severity and family outcomes: a systematic review of assessments and findings in psychosocial research. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

National Cross-Sectional Study of Mental Health Screening Practices for Primary Caregivers of NICU Infants. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A different kind of battle: the effects of NICU admission on military parent mental health. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Recommendations for mental health professionals in the NICU. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Psychosocial program standards for NICU parents. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

"All these people saved her life, but she needs me too": Understanding and responding to parental mental health in the NICU. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Neonatal Continuing Education That Powers Family-Centered Care Like Never Before. [2021]