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Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite)

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ClinicalTrials.gov Identifier: NCT03704272
Recruitment Status : Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : October 18, 2018
Sponsor:
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

  Show Detailed Description

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
SunBrite
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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03704272


Contacts
Contact: Lois Sayrs, PhD 602-933-0148 lsayrs@phoenixchildrens.com
Contact: Jodie Greenberg, MA 602-933-4045 jgreenberg@phoenixchildrens.com

Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: David M Notrica, MD Phoenix Children's Hospital