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OpenTrials
Recruiting

NCT Number: NCT05809115

Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Michelle Lopez, MD, MPH

CONTACT

[email protected]

832-824-6044

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Maternal Child Bonding

    Time frame: 6 months

    The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Lopez, MD, MPH

CONTACT

[email protected]

832-824-6044

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Episcopal Health Foundation

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 12, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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