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Recruiting NCT05809115

Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

Observational Food Insecurity Depression Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Food Insecurity, Depression, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Primary outcome measures

  • Maternal Child Bonding [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Texas Children's Hospital — Houston

Publications

  • 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 36594231

Identifiers

NCT: NCT05809115 · H-53133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗