Neglect, Child clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03704272 Not yet recruiting - Head Trauma Clinical Trials

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

SunBrite

Start date: January 2020
Phase: N/A
Study type: Interventional

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.