RecruitingRecruiting
Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
NCT05809115 · Baylor College of Medicine
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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).
Eligibility criteria
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 design
Enrollment target: 2000 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-06-14
Estimated completion: 2027-06
Last updated: 2026-04-30
Primary outcomes
- • Maternal Child Bonding (6 months)
Sponsor
Baylor College of Medicine · other
With: Episcopal Health Foundation
Contacts & investigators
ContactMichelle Lopez, MD, MPH · contact · malopez@texaschildrens.org · 832-824-6044
InvestigatorMichelle Lopez, MD, MPH · principal_investigator, Baylor College of Medicine
All locations (1)
Texas Children's HospitalRecruiting
Houston, Texas, United States