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Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05809115
Enrollment
2000
Registered
2023-04-12
Start date
2023-06-14
Completion date
2027-06-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Food Insecurity

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.

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).

Interventions

None listed

Sponsors

Baylor College of Medicine
Lead SponsorOTHER
Episcopal Health Foundation
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 Child Protective Services (CPS) custody * Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas) * Previous enrollment in this study (H-53133) or H-57296. * Patient is in the process of being discharged/observation status administration. * Caregiver is not the primary caregiver.

Design outcomes

Primary

MeasureTime frameDescription
Maternal Child Bonding3 monthsThe validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.

Countries

United States

Contacts

CONTACTMichelle Lopez, MD, MPH
malopez@texaschildrens.org832-824-6044
PRINCIPAL_INVESTIGATORMichelle Lopez, MD, MPH

Baylor College of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026