Neurodevelopmental Outcomes in Children: Strengthening th... | NCT05809115

Studies
Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

NCT05809115

Sponsor

Baylor College of Medicine

Status

Recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Food Insecurity
Depression
Anxiety

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Apr 10, 2023

First Posted Date

Apr 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2026

Last Update Posted Date

Apr 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle Lopez, Associate Professor of Pediatrics, Baylor College of MedicinePrincipal Investigator

Lead Sponsor

Baylor College of MedicineOTHER

Collaborators

Name	Class
Episcopal Health Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurocognitive Outcomes		Surveys General behavioral, economic, and household resources
Neurodevelopmental Outcomes		Surveys Individualized behavioral, economic, and household resources

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michelle Lopez, MD, MPH	Contact	832-824-6044		malopez@texaschildrens.org

Overall Officials

Name	Affiliation	Role
Michelle Lopez, MD, MPH	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Children's Hospital	Recruiting	Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36594231	Background	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.

ID	Term
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders