NCT04540003 - Clinical Trial References

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.

Citation(s)

Breslau J, Miller E, Breslau N, Bohnert K, Lucia V, Schweitzer J
The impact of early behavior disturbances on academic achievement in high school. Pediatrics. 2009 Jun;123(6):1472-6. doi: 10.1542/peds.2008-1406.
Reynolds AJ, Temple JA, Ou SR, Robertson DL, Mersky JP, Topitzes JW, Niles MD
Effects of a school-based, early childhood intervention on adult health and well-being: a 19-year follow-up of low-income families. Arch Pediatr Adolesc Med. 2007 Aug;161(8):730-9.
Shevell MI, Majnemer A, Rosenbaum P, Abrahamowicz M
Profile of referrals for early childhood developmental delay to ambulatory subspecialty clinics. J Child Neurol. 2001 Sep;16(9):645-50.

School Based Health Care: A Model for Improving Educational Achievement for Children in Inner City Schools

Clinical trial NCT04540003 - References