Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

April 25, 2026 updated by: Michelle Lopez, Baylor College of Medicine

The main goal of this research is to help families who are experiencing food insecurity (FI) and help mothers with depression.

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

Aim 1: Implement a refined mental health (MH) intervention in caregivers of hospitalized children: sessions with a Behavioral Health Clinician (BHC) with more individualized support based on caregiver-child needs, instruction on caregiver-child bonding, and a streamlined handoff to a community MH provider. Follow-up outcomes include caregiver MH and caregiver-child attachment (survey) and child development (electronic health records, EHR).

Aim 2: Execute an enhanced intervention for FI. All families who screen positive for FI will still receive assistance with public benefit enrollment and access to local food pantries. Families with additional needs will receive support for 10 additional non-medical drivers of health (NMDH). Assistance will be provided by onsite Houston Food Bank (HFB) Community Referral Specialists. Follow-up outcomes include enrollment in public/community resources and food security status (survey).

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
          • Michelle Lopez, MD, MPH
          • Phone Number: 832-824-6044
          • Email: malopez@bcm.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population are the caregivers of children hospitalized at Texas Children's Hospital.

Description

Inclusion Criteria:

  • Caregivers of young children (0-36 months of age) hospitalized at Texas Children's Hospital on acute care units.
  • English or Spanish speaking caregiver.
  • Age of caregiver ≥ 18 years old.
  • Hospital day 2 or later of patient admission.

Exclusion Criteria:

  • Caregivers who do not have primary custody
  • Children in CPS custody
  • Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas)
  • Previous enrollment in this study.
  • Patient is in the process of being discharged/observation status administration.
  • Caregiver is not the primary caregiver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Neurocognitive Outcomes
  • Surveys
  • General behavioral, economic, and household resources
Neurodevelopmental Outcomes
  • Surveys
  • Individualized behavioral, economic, and household resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Child Bonding
Time Frame: 6 months
The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Episcopal Health Foundation

Investigators

  • Principal Investigator: Michelle Lopez, MD, MPH, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-53133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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