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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. Identifier: NCT03704272
Recruitment Status : Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Phoenix Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Neglect, Child Non-Accidental Trauma Non-Accidental Injury to Child Head Trauma Behavioral: SunBrite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 221 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Families in the control group will receive treatment as usual, which includes reporting to child welfare agencies when appropriate.
Experimental: Treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Complications from traumatic head injury [ Time Frame: 12 months post enrollment ]
    Any complications resulting from intracranial injury that child presents with in ED.

  2. 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.

  3. Cost savings [ Time Frame: 12 months post enrollment ]
    Savings resulting from reduced ED visits and readmissions to hospital.

  4. Frequency of re-hospitalization [ Time Frame: 12 months post enrollment ]
    Measured by number of hospital admissions as recorded in the patient's medical chart.

  5. Hospital lengths of stay [ Time Frame: 12 months post enrollment ]
    Measured in days as recorded in the patient's medical chart.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Pediatric patients under the age of 2 presenting to the ED with intracranial trauma not resulting from a motor vehicle accident.
  • Children admitted overnight for observation may be included in the study. Because of the age of the child, most children are held overnight or longer.

Exclusion Criteria

  • Children with a head injury associated with a motor vehicle collision.
  • Children whose guardian does not present in the ED with the patient at the time of admission.
  • Children with developmental disabilities or autism.
  • Medically fragile children, children with chronic illness, or children diagnosed with failure to thrive.
  • Caregivers/guardians who do not speak English or Spanish

Information from the National Library of Medicine

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 identifier (NCT number): NCT03704272

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Contact: Lois Sayrs, PhD 602-933-0148
Contact: Jodie Greenberg, MA 602-933-4045

Sponsors and Collaborators
Phoenix Children's Hospital
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Principal Investigator: David M Notrica, MD Phoenix Children's Hospital
Publications of Results:
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Responsible Party: Phoenix Children's Hospital Identifier: NCT03704272    
Other Study ID Numbers: 18-151
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases