Addressing Caregiver Wellbeing and Improving Child Development

Sponsor
Baylor College of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05809115
Collaborator
Episcopal Health Foundation (Other)
1,000
20.3

Study Details

Study Description

Brief Summary

The goal of this study is to study whether the investigators can improve maternal child bonding and ultimately development in young children by helping caregivers with food insecurity and mental health needs. Both food insecurity and maternal depression has been linked to delays in development for children. This is a clinical trial in the mothers of hospitalized children 0-3 years of age.

Participants who consent will complete a screening survey on social needs, food insecurity, stress, depression, and anxiety. There is not a comparison group. All caregivers who are identified as having food insecurity and/or anxiety or depression will receive study interventions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study aim is to implement a bundle of neurodevelopmental interventions and employ an intergenerational care model, focused on the needs of young children and their parents to maximize health benefits to the child. The investigators will address two major upstream factors significantly associated with poor neurocognitive and developmental outcomes in children - caregiver mental health and household food insecurity.

    The research coordinator (referred to as the caregiver advocate) will be responsible for coordination of screening and interventions. They will approach the caregivers of young children (0-36 months of age) hospitalized at Texas Children's Hospital. The Caregiver Advocate will explain the project goal of improving children's brain development and consent families who agree to study participation.

    Screening The Caregiver Advocate will be trained by the Primary Investigators (PIs) in a patient-centered, empathic communication curriculum, which has been used in the team's previous studies. Under the PIs guidance, the Caregiver Advocate will screen the caregiver using an electronic tablet to screen for social needs with a focus on caregiver mental health using validated depression and anxiety screens, perceived stress scale, insurance status, food insecurity using the 18 question USDA survey, and maternal child attachment inventory. Each of these will be use an existing validated screening tool. Demographic data and all study data will be collected in RedCap. Data will be deidentified in analysis and identifiable information will not be shared with anyone outside of the BCM/TCH study team. Data will be stored through the secure password protected BCM/TCH servers. Children will not be surveyed.

    Response to Positive Screens: The Caregiver Advocate will refer all caregivers with positive depression screens to the team Behavioral Health Clinician (BHC). The BHC is a licensed mental health professional and staff under the Department of Psychology with educational training in behavioral and mental health services including counseling. They will meet with every caregiver who screens positive for depression. For their role in this study, the BHC will be trained as a Behavioral Health Consultant.

    The Caregiver Advocate will refer all caregivers who screen positive for food insecurity (FI) to the Houston Food Bank (HFB) navigators via the FIRST Link program. The goal of this program is to increase resources for patients experiencing FI by connecting caregivers within a healthcare setting to food resources and social services. The HFB navigator will address emergent household food needs with resources such as locating food pantries, and they will also assist families in applying for public benefits such as SNAP and resources for other health related social needs shared by the caregivers. Caregivers with household FI will also be enrolled in a hospital food assistance program to receive complimentary meals delivered to their child's bedside throughout their hospital stay. Caregivers with food insecurity will also be offered a complementary caregiver tray, which is provided to all hospitalized families at Texas Children's Hospital who are identified as needing food assistance in the hospital. The study hypothesis is that direct referral of caregivers to public resources will improve connection to resources and household food security levels.

    Follow Up: The Caregiver Advocate will conduct follow up visits in person (if the child remains hospitalized) or by phone at 1 week and 2 months to assist the caregiver with barriers to accessing resources and follow up on study outcomes. The team will communicate screening and intervention results with the primary hospital physician and PCP using the electronic medical record.

    The team will also collect information on the pediatric patient with an electronic medical record data pull "frontdoor" request for demographics, length of stay, primary care visit developmental screens, subspecialty referral to development services, and diagnoses codes.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Addressing Caregiver Wellbeing and Improving Child Development
    Anticipated Study Start Date :
    Apr 24, 2023
    Anticipated Primary Completion Date :
    Nov 24, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Maternal Child Bonding [2 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Caregivers of young children (0-36 months of age) hospitalized at Texas Children's Hospital on acute care units.
    Exclusion Criteria:
    • Caregivers who do not have primary custody

    • Children in CPS custody

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Baylor College of Medicine
    • Episcopal Health Foundation

    Investigators

    • Principal Investigator: Michelle Lopez, MD, MPH, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michelle Lopez, Associate Professor of Pediatrics, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT05809115
    Other Study ID Numbers:
    • H-53133
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2023