Addressing Caregiver Wellbeing and Improving Child Development

Depression Clinical Trial

Official title:

Addressing Caregiver Wellbeing and Improving Child Development

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05809115
• Other study ID #: H-53133
• Status: Active, not recruiting
• Start date: June 14, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 staff 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 research staff will explain the project goal of improving children's brain development and consent families who agree to study participation.

Screening Research staff will be trained by the Primary Investigators (PIs) in a patient-centered, empathic communication curriculum, which has been used in our previous studies. The research staff will identify patients using a pre-screening list in Epic Electronic Medical Record. Caregivers of uninsured or publicly insured patients will be approached first followed by patients with private insurance, with the goal of approaching all caregivers eligible for the study before they are discharged from the hospital. Under the PIs guidance, the research staff 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. Information regarding the participants needs in obtaining a job, quitting smoking, utilities assistance, low-cost legal assistance, and educational assistance and background will also be collected. Each of these will be use an existing validated screening tool. The enrollment survey is available in English and Spanish and provided in the attachments. 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 research staff will refer all caregivers with positive depression and anxiety 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 and anxiety. For their role in this study, the BHC will be trained as a Behavioral Health Consultant.

The research staff 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. Our hypothesis is that direct referral of caregivers to public resources will improve connection to resources and household food security levels.

The study related materials, such as the information on resources that they request in the survey including information on insurance, finding a primary care physician, Brain Builders (a free community resource for mothers of young children to learn about development), and the Houston foodbank (forms commonly used in patient care outside of research) will be given to subjects via several methods (i.e., text, email, mail, etc.). Additionally, various standard of care forms, such as food tray menus, early childhood intervention services forms, and Centers for Disease Control Developmental Milestones forms, which are routinely given to patients regardless of their participation in this study will be provided. All resources are available on a padlet website (https://padlet.com/malopez98/caregiver-wellbeing-and-child-development-resources-recursos-ao 06uh6nii0scdtg). Handouts which were created specifically for this study, such as the insurance and PCP forms, are attached.

The team will communicate screening and intervention results with the primary hospital physician and PCP using the electronic medical record.

Follow Up: The research staff will conduct follow up visits in person (if the child remains hospitalized) or by phone at 1 week and 2 months after study enrollment to assist the caregiver with barriers to accessing resources and follow up on study outcomes. The research staff will attempt to contact the subject at least three times by phone and one time by email in an attempt to complete the follow-up study visits. Research subjects will also be given a secure link to the 2 month survey. Follow up surveys will be conducted over the phone in English or with a certified Spanish interpreter or in the hospital if the patient has not been discharged. Survey will be read by the research staff in English and translated verbally in Spanish as needed at time of follow up completion as most follow up will be conducted over the phone and the research staff will enter follow up responses directly into the tablet. In the event that a patient passes away from the time of caregiver enrollment to follow up, then existing data will still be analyzed and no follow up phone call will be placed.

We 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.

Participants will be given the option to consent to being contacted for future studies. A separate consent form would be signed for future studies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 520
• Est. completion date: September 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• Caregiver is not the primary caregiver.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Food Insecurity

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Episcopal Health Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Child Bonding	The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.	2 months