Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
1 other identifier
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
June 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 30, 2026
April 1, 2026
3.5 years
March 20, 2023
April 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal Child Bonding
The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.
6 months
Study Arms (2)
Neurocognitive Outcomes
* Surveys * General behavioral, economic, and household resources
Neurodevelopmental Outcomes
* Surveys * Individualized behavioral, economic, and household resources
Eligibility Criteria
The population are the caregivers of children hospitalized at Texas Children's Hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- Episcopal Health Foundationcollaborator
Study Sites (1)
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Lopez MA, Yu X, Hetrick R, Raman S, Lee J, Hall J, Tran K, Vonasek B, Garg A, Raphael J, Bocchini C. Social Needs Screening in Hospitalized Pediatric Patients: A Randomized Controlled Trial. Hosp Pediatr. 2023 Feb 1;13(2):95-114. doi: 10.1542/hpeds.2022-006815.
PMID: 36594231BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Lopez, MD, MPH
Baylor College of Medicine
Central Study Contacts
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
March 20, 2023
First Posted
April 12, 2023
Study Start
June 14, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
IPD data will not be shared with other researchers