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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist parents of preterm infants transitioning home from the NICU by testing a telehealth program called PATH. This program screens for depression, anxiety, and PTSD (post-traumatic stress disorder) and provides support based on the parents' risk levels. Parents at low risk receive a brief behavioral intervention, while those at medium to high risk are referred to community mental health services. The trial seeks parents who have had a preterm baby in the NICU for at least two weeks and speak English or Spanish. As an unphased trial, it offers a unique opportunity for parents to access tailored mental health support during a critical transition period.

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 prior data suggests that this program is safe for NICU parents?

Research has not provided specific safety data for the PATH Program itself. However, the program emphasizes mental health support, typically involving activities like counseling or therapy, which are generally safe and well-received.

The PATH Program monitors for signs of depression, anxiety, and PTSD, offering short-term behavioral support. This type of support is usually safe and can enhance mental health. As the study is in a "Not Applicable" phase, it does not test new drugs, which often raise more safety concerns. Instead, it focuses on mental health care, providing emotional and psychological support.

Although specific safety data is lacking, mental health programs like this one aim to help, not harm, making them a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATH Program for NICU Parent Mental Health because it tackles the mental health challenges of parents with infants in the NICU through a unique approach. While standard care often involves general support, the PATH Program offers anticipatory guidance and brief behavioral interventions, providing targeted mental health strategies. This program also facilitates referrals to community mental health providers, ensuring parents receive comprehensive care tailored to their needs. By focusing on proactive mental health support, the PATH Program aims to enhance parents' well-being more effectively than traditional methods.

What evidence suggests that the PATH program is effective for NICU parent mental health?

Research shows that parents of babies in the NICU often face mental health issues like depression, anxiety, and PTSD. In this trial, the PATH program aims to help by offering mental health check-ups and support through online services. Participants in the intervention arm will receive anticipatory guidance, brief behavioral intervention, or referral to a community mental health provider. Studies have found that programs involving the whole family can improve parents' mental health. Early results suggest that providing parents with timely mental health support and connecting them to local services can be effective. This approach helps parents manage stress and enhances their overall well-being as they transition from the hospital to home. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/path-program-for-nicu-parent-mental-health-5aaab

PATH Program for NICU Parent Mental Health 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9199311/

“All these people saved her life, but she needs me too ... Introduction. Parents of infants hospitalized in the neonatal intensive care unit (NICU) are at increased risk of poor mental health outcomes.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788311

Family Integrated Care Model and Paternal Mental Health ... This cohort study examines the association of a family integrated care model vs standard neonatal care with mental health outcomes among ...

4. reporter.nih.gov reporter.nih.gov/project-details/8539827

Improving Preterm Outcomes by Safeguarding Maternal ... The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition from Hospital to Home. 493, 5K08MH127519-04Project Numberf.

5. mdpi.com mdpi.com/2227-9067/11/10/1260

Evaluation of a Model of Transitional Care After Preterm ... In this randomized controlled pilot trial (RCT), the feasibility of performing an experimental study to analyse the effects of TtH on parental mental health ...

6. reporter.nih.gov reporter.nih.gov/search/10EECF0E478FC3D57598B8961CAA4A01A2FFCEB861BF/project-details/11060075

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/15394492231160690

Infant and Parent Outcomes Related to NICU-Based Co- ... Neonatal intensive care unit (NICU) co-occupations may impact parent–infant outcomes. The main objective of this study was to explore ...