Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

NCT ID: NCT05809115

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-14

Study Completion Date

2026-03-31

Brief Summary

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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

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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).

Conditions

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Food Insecurity Depression Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurocognitive Outcomes

* Surveys
* General behavioral, economic, and household resources

No interventions assigned to this group

Neurodevelopmental Outcomes

* Surveys
* Individualized behavioral, economic, and household resources

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Episcopal Health Foundation

UNKNOWN

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Michelle Lopez

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Lopez, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 36594231 (View on PubMed)

Other Identifiers

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H-53133

Identifier Type: -

Identifier Source: org_study_id

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