Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03704272|
Recruitment Status : Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neglect, Child Non-Accidental Trauma Non-Accidental Injury to Child Head Trauma||Behavioral: SunBrite||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Control group (Treatment as usual) vs. Treatment group (screening, brief intervention and referral to treatment)|
|Masking:||None (Open Label)|
|Official Title:||Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite)|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
No Intervention: Control
Families in the control group will receive treatment as usual, which includes reporting to child welfare agencies when appropriate.
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.
- Return visits to emergency department for any ICD-10 code [ Time Frame: 12 months post enrollment ]Measured by the number of admissions to the ED as recorded in the patient's medical chart.
- Complications from traumatic head injury [ Time Frame: 12 months post enrollment ]Any complications resulting from intracranial injury that child presents with in ED.
- All illnesses and conditions of participant, including those unrelated to traumatic head injury [ Time Frame: 12 months post enrollment ]Assessed via review of illnesses and conditions as recorded in the patient's medical chart.
- Cost savings [ Time Frame: 12 months post enrollment ]Savings resulting from reduced ED visits and readmissions to hospital.
- Frequency of re-hospitalization [ Time Frame: 12 months post enrollment ]Measured by number of hospital admissions as recorded in the patient's medical chart.
- Hospital lengths of stay [ Time Frame: 12 months post enrollment ]Measured in days as recorded in the patient's medical chart.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704272
|Contact: Lois Sayrs, PhDfirstname.lastname@example.org|
|Contact: Jodie Greenberg, MAemail@example.com|
|Principal Investigator:||David M Notrica, MD||Phoenix Children's Hospital|