[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05809115":3,"trial-entities:NCT05809115":83,"trial-summary:NCT05809115":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":35,"minimum_age":36,"maximum_age":23,"healthy_volunteers":37,"eligibility_criteria":38,"std_ages":52,"locations":55,"central_contacts":71,"overall_officials":74,"references":77,"see_also_links":82},"NCT05809115","H-53133","Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story","RECRUITING","2027-06","2026-08","2026-08-31","2023-06-14","Baylor College of Medicine","OTHER",false,"The main goal of this research is to help families who are experiencing food insecurity (FI) and help mothers with depression.\n\nThe 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.","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).\n\nAim 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\u002Fcommunity resources and food security status (survey).",[18,19,20],"Food Insecurity","Depression","Anxiety",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},2000,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Maternal Child Bonding","The validated Maternal Attachment Inventory will be used for data collection. Higher scores indicate greater maternal child bonding.","3 months",[],"ALL","18 Years",true,{"inclusion":39,"exclusion":44,"raw_text":51},[40,41,42,43],"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.",[45,46,47,48,49,50],"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\u002Fobservation status administration.","Caregiver is not the primary caregiver.","Inclusion Criteria:\n\n* Caregivers of young children (0-36 months of age) hospitalized at Texas Children's Hospital on acute care units.\n* English or Spanish speaking caregiver.\n* Age of caregiver ≥ 18 years old.\n* Hospital day 2 or later of patient admission.\n\nExclusion Criteria:\n\n* Caregivers who do not have primary custody\n* Children in Child Protective Services (CPS) custody\n* Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas)\n* Previous enrollment in this study (H-53133) or H-57296.\n* Patient is in the process of being discharged\u002Fobservation status administration.\n* Caregiver is not the primary caregiver.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":68},"Texas Children's Hospital","Houston","Texas","77030","United States",[63],{"name":64,"role":65,"phone":66,"email":67},"Michelle Lopez, MD, MPH","CONTACT","832-824-6044","malopez@bcm.edu",{"lat":69,"lon":70},29.76328,-95.36327,[72],{"name":64,"role":65,"phone":66,"email":73},"malopez@texaschildrens.org",[75],{"name":64,"affiliation":12,"role":76},"PRINCIPAL_INVESTIGATOR",[78],{"pmid":79,"type":80,"citation":81},"36594231","BACKGROUND","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\u002Fhpeds.2022-006815.",[],{"nct_id":4,"conditions":84,"biomarkers":85},[20,19,18],[],{"nct_id":4,"found":37,"summary":87,"prompt_version":97},{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an observational study, meaning researchers will observe and collect information without providing specific interventions to all participants. It aims to enroll 2000 participants.","completed","Understanding Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story","This observational study aims to help families dealing with food insecurity and mothers experiencing depression or anxiety. Researchers will provide support for mental health and household needs like rent or utilities. The goal is to see if helping with these issues improves children's development and strengthens the bond between caregivers and children. Success will be measured by looking at how caregivers and children bond at 6 months. You might be able to join if you are a caregiver of a young child (0-36 months) hospitalized at Texas Children's Hospital, are at least 18 years old, speak English or Spanish, and are on day 2 or later of the patient's admission. The study is currently unclear on its recruitment status and plans to enroll 2000 participants.","The primary outcome, maternal-child bonding, is measured at 6 months.",125,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]