WithdrawnNot Applicable

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

Stopped: Study was never initiated. No IRB approval obtained, and no participants enrolled.

0Started 2021-01

Plain-language 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Return visits to emergency department for any ICD-10 code

Timeframe: 12 months post enrollment

Trial details

NCT IDNCT03704272

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Neglect, Child trials