Food InsecurityNCT05809115
Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
An observational study of Food Insecurity and Depression, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Depression, Anxiety
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population are the caregivers of children hospitalized at Texas Children's Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Michelle Lopez, MD, MPH, 832-824-6044, malopez@bcm.edu
About this study
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.
Read the 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).
- Conditions
- Food Insecurity, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive Outcomes | * Surveys * General behavioral, economic, and household resources | |
| Neurodevelopmental Outcomes | * Surveys * Individualized behavioral, economic, and household resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Child Bonding
The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start14 Jun 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Episcopal Health Foundation
- Responsible party
- Principal investigator, Michelle Lopez, Baylor College of Medicine
- Investigators
- Michelle Lopez, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809115
- Sponsor's protocol ID
- H-53133
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) data will not be shared with other researchers
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.
PubMed 36594231
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story
- ClinicalTrials.gov ID
- NCT05809115
- Acronym / sponsor ID
- H-53133
- Conditions
- Food Insecurity, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Episcopal Health Foundation
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Outcomes | – | –* Surveys * General behavioral, economic, and household resources |
| Neurodevelopmental Outcomes | – | –* Surveys * Individualized behavioral, economic, and household resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population are the caregivers of children hospitalized at Texas Children's Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal Child Bonding
Time frame: 3 months
The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 36594231Lopez 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.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) data will not be shared with other researchers
Related trials for Food Insecurity
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Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
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Addressing Food Insecurity in Pregnancy
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Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Lopez, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity and Depression, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lopez, MD, MPH (832-824-6044, malopez@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Child Bonding (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.