Neonatal Neurodevelopmental Outcomes

NCT ID: NCT07101757

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2026-08-01

Brief Summary

The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby.

The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.

Detailed Description

The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child.

There is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.

Additionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.

The findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.

Conditions

Food Insecurity; Depression; Anxiety; Stress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Positive Screens

• Enrollment survey
• Referral to behavior health clinician (BHC)
• Referral to emergency psychiatric services
• Referral the Houston Food Bank (HFB)
• Follow-up surveys

No interventions assigned to this group

Negative Screens

-Enrollment survey

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Caregivers of young infants (0-6 months of age) hospitalized at Texas Children's Hospital intensive care or acute care units.
• English or Spanish speaking caregiver.
• Age of caregiver ≥ 18 years old.
• Caregiver willing to complete study procedures.

Exclusion Criteria

• Caregivers who do not have primary custody.
• Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas).
• Children in CPS custody.
• Caregiver is not the primary caregiver.
• Previous enrollment in this study.
• Neonates who are non-viable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Episcopal Health Foundation

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Michelle Lopez

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Texas Children's Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michelle Lopez, MD, MPH

Role: CONTACT

malopez@texaschildrens.org

832-824-6044

Facility Contacts

Michelle Lopez, MD, MPH

Role: primary

malopez@bcm.edu

832-824-6044

Other Identifiers

H-57296

Identifier Type: -

Identifier Source: org_study_id