Neonatal Neurodevelopmental Outcomes

Recruiting

• Conditions: Food Insecurity; Depression; Anxiety; Stress

• Registration Number: NCT07101757
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-28
• Study First Posted: 2025-08-03
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-06
• Study Start: 2025-09-08
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Implementation	12 months	Assessed by the proportion of eligible participants who enroll and complete the intervention protocol.; Unit of Measure: Percentage of participants completing the intervention.
Acceptability of Intervention	12 months	Measured using the Acceptability of Intervention Measure (AIM), a validated 4-item Likert scale assessing participant perceptions of the intervention.; Unit of Measure: Mean AIM score (range: 1-5).
Caregiver-Infant Bonding and Nurture	12 months	Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding.; Unit of Measure: Mean PBQ score.
Caregiver Mental Health Outcomes	12 months	Evaluated using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) scale for anxiety.; Unit of Measure: Mean scores on PHQ-9 and GAD-7.
Addressing Non-Medical Drivers of Health	12 months	Measured by the number of referrals made to food, housing, or mental health resources and the proportion of participants who accessed at least one referred service.; Unit of Measure: Count of referrals and percentage of participants accessing services.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States