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

NCT03704272 | Withdrawn

• 1 other identifier: 18-151
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neglect, Child; Non-Accidental Trauma; Non-Accidental Injury to Child; Head Trauma

Outcome Measures

Primary Outcomes (1)

• Return visits to emergency department for any ICD-10 code

  Measured by the number of admissions to the ED as recorded in the patient's medical chart.

  12 months post enrollment

Secondary Outcomes (5)

• Complications from traumatic head injury

  12 months post enrollment

• All illnesses and conditions of participant, including those unrelated to traumatic head injury

  12 months post enrollment

• Cost savings

  12 months post enrollment

• Frequency of re-hospitalization

  12 months post enrollment

• Hospital lengths of stay

  12 months post enrollment

Study Arms (2)

Control

NO INTERVENTION

Families in the control group will receive treatment as usual, which includes reporting to child welfare agencies when appropriate.

Treatment

EXPERIMENTAL

SunBrite

Behavioral: SunBrite

Interventions

SunBrite BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Related Publications (3)

• Louwers EC, Korfage IJ, Affourtit MJ, Scheewe DJ, van de Merwe MH, Vooijs-Moulaert FA, Woltering CM, Jongejan MH, Ruige M, Moll HA, De Koning HJ. Detection of child abuse in emergency departments: a multi-centre study. Arch Dis Child. 2011 May;96(5):422-5. doi: 10.1136/adc.2010.202358. Epub 2011 Jan 30.

  PMID: 21278429 RESULT

• King WK, Kiesel EL, Simon HK. Child abuse fatalities: are we missing opportunities for intervention? Pediatr Emerg Care. 2006 Apr;22(4):211-4. doi: 10.1097/01.pec.0000208180.94166.dd.

  PMID: 16651907 RESULT

• Bray JW, Del Boca FK, McRee BG, Hayashi SW, Babor TF. Screening, Brief Intervention and Referral to Treatment (SBIRT): rationale, program overview and cross-site evaluation. Addiction. 2017 Feb;112 Suppl 2:3-11. doi: 10.1111/add.13676.

  PMID: 28074566 RESULT

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• David M Notrica, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group (Treatment as usual) vs. Treatment group (screening, brief intervention and referral to treatment)

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share