Neonatal Neurodevelopmental Outcomes

NCT07101757 | Active Not Recruiting

• 1 other identifier: H-57296
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity; Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention Implementation

  Assessed by the proportion of eligible participants who enroll and complete the intervention protocol. Unit of Measure: Percentage of participants completing the intervention.

  12 months

• Acceptability of Intervention

  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).

  12 months

• Caregiver Mental Health Outcomes

  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.

  12 months

• Caregiver-Infant Bonding and Nurture

  Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding. Unit of Measure: Mean PBQ score.

  12 months

• Addressing Non-Medical Drivers of Health

  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.

  12 months

Study Arms (2)

Positive Screens

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

Negative Screens

-Enrollment survey

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include adult caregivers (18 years or older) who speak English or Spanish and have infants aged 0-6 months hospitalized at Texas Children's Hospital. Caregivers must be willing to participate in study activities. Those without primary custody, living outside Texas, or previously enrolled in the study will not be eligible

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Episcopal Health Foundation: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 3, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)