Clinical trial Recruiting at 1 site Observational Ages 18 and up

Helping families with food insecurity and caregiver mental health

Official title: Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

Run by Baylor College of Medicine · NCT05809115 · Data updated 2026-11-12

This study is trying to see if helping mothers with depression and families struggling to get enough food can improve their mental health and strengthen their relationships with their children.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2000 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJune 14, 2023
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedAugust 31, 2026
Trial IDNCT05809115 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include English or Spanish-speaking caregivers of young children aged 0-36 months who are hospitalized at Texas Children's Hospital.

Probably not a fit

Patients who may not benefit include those without primary custody of the child or caregivers living outside of Texas.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to support families facing food insecurity and assist mothers dealing with depression. It involves implementing a mental health intervention for caregivers of hospitalized children, focusing on enhancing caregiver-child bonding and connecting them with community mental health resources. Additionally, families identified as food insecure will receive assistance with public benefits and access to local food pantries, along with support for other non-medical needs. The study will track outcomes related to caregiver mental health, attachment, and child development through surveys and electronic health records.

Why it matters

Potential benefit: If successful, this initiative could significantly improve the mental health of caregivers and the overall well-being of children in food-insecure households.

How similar studies have gone: Other studies have shown success in addressing food insecurity and mental health in similar populations, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion 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 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.

Where it's running

  • Texas Children's Hospital
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.