Neonatal Neurodevelopmental Outcomes

Baylor College of Medicine

Status: Enrolling

Conditions: Food Insecurity; Depression; Anxiety; Stress

Study type: Observational

Funder types: Other

Identifiers

NCT07101757

H-57296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Positive Screens

Description:

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

Negative Screens

Description:

-Enrollment survey