Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral
NCT03704272 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-11-20
Summary
The Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite) protocol is a family-empowered, risk mitigation strategy that targets families with young children who present to the ED with intracranial trauma. Based on the widely utilized screening, brief intervention, and referral to treatment (SBIRT) protocol, SunBrite has 3 core components: screening, brief motivational interview, and referral for treatment. PCH will: 1) engage community partnerships to support SunBrite development; 2) utilize participatory action research approach for design, implementation, process evaluation, and dissemination of the pilot program; and 3) evaluate intervention implementation and pilot outcomes. Over a 2-year period, this study will encompass a pilot intervention and implementation assessment and a randomized trial to evaluate outcomes. Implementation of SunBrite will yield rigorous scientific evidence for a sustainable, evidenced-based, widely-needed non-accidental (NAT) screening and intervention for families with young children.
Conditions
- Neglect, Child
- Non-Accidental Trauma
- Non-Accidental Injury to Child
- Head Trauma
Interventions
- BEHAVIORAL
-
SunBrite
SunBrite is a family-empowered injury risk mitigation intervention with 3 core components: screening for the risk of supervisory neglect associated with traumatic injury in very young children; a brief behavioral intervention using motivational interviewing designed to provide feedback to the caregiver on supervisory risk and traumatic injury; and a referral to treatment for ongoing risks such as substance abuse, trauma or mental illness, requiring specific clinical interventions.
Sponsors & Collaborators
-
Phoenix Children's Hospital
lead OTHER
Principal Investigators
-
David M Notrica, MD · Phoenix Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-31
- Primary Completion
- 2021-05-31
- Completion
- 2021-06-30
More Related Trials
-
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
NCT02793999 ·Status: RECRUITING
-
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
NCT01550627 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
NCT00620711 ·Status: COMPLETED ·Phase: PHASE1
-
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
NCT02071394 ·Status: COMPLETED ·Phase: PHASE2
-
Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
NCT02683915 ·Status: COMPLETED
-
Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
NCT02612727 ·Status: COMPLETED ·Phase: NA
-
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
NCT03696745 ·Status: UNKNOWN ·Phase: PHASE1
-
Clinical and Developmental Outcomes of Babies Who Became Yellow in the First Month of Life
NCT02927093 ·Status: COMPLETED
-
Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
NCT03640494 ·Status: COMPLETED
-
Amnioinfusion for Intrauterine Neuroprotection
NCT05513690 ·Status: UNKNOWN ·Phase: NA
-
The TOBY Children Study
NCT01092637 ·Status: COMPLETED
-
Cooling in Mild Encephalopathy
NCT05889507 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
NCT01732146 ·Status: COMPLETED ·Phase: PHASE3
-
Neonatal Hypoxic Ischemic Encephalopathy:Early Diagnosis and Management of Comorbidities
NCT03550612 ·Status: UNKNOWN
-
Newborn Kit to Save Lives and Brains in Kenya
NCT02208960 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
NCT03162653 ·Status: RECRUITING ·Phase: PHASE3
-
Hypothermia During ECMO to Decrease Brain Injury
NCT01675388 ·Status: WITHDRAWN ·Phase: NA
-
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
NCT01207778 ·Status: COMPLETED
-
Erythropoietin in Management of Neonatal Hypoxic Ischemic Encephalopathy
NCT03163589 ·Status: UNKNOWN ·Phase: PHASE3
-
Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
NCT05666362 ·Status: COMPLETED ·Phase: PHASE4
-
Autologous Umbilical Cord Blood Treatment of Neonate With CHD
NCT03558269 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
NCT04584983 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
NCT00589953 ·Status: TERMINATED ·Phase: PHASE2
-
Inflammation and Cerebral Oxygenation in Preterm Newborns Following Fetal Red Blood Cell Transfusion Compared to Adult Red Blood Cell Transfusion
NCT06851390 ·Status: COMPLETED
-
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
NCT00890409 ·Status: COMPLETED ·Phase: PHASE3