Clinical trial NCT05809115: Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
Official title: Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Food Insecurity
Depression
Anxiety
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Episcopal Health Foundation
First posted: 2023-04-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population are the caregivers of children hospitalized at Texas Children's Hospital.

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).

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.

Primary outcomes:
measure: Maternal Child Bonding
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Michelle Lopez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.