NCT04873518 - 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)

Leblond M, Parent S, Castellanos-Ryan N, Lupien SJ, Fraser WD, Séguin JR
Transition from preschool to school: Children's pattern of change in morning cortisol concentrations. Psychoneuroendocrinology. 2022 Mar 14;140:105724. doi: 10.1016/j.psyneuen.2022.
Parent S, Lupien S, Herba CM, Dupéré V, Gunnar MR, Séguin JR
Children's cortisol response to the transition from preschool to formal schooling: A review. Psychoneuroendocrinology. 2019 Jan;99:196-205. doi: 10.1016/j.psyneuen.2018.09.013. Epub 2018 Sep 14. Review.
Rioux C, Parent S, Castellanos-Ryan N, Archambault I, Boivin M, Herba CM, Lupien SJ, Marc I, Muckle G, Fraser WD, Séguin JR
The 3D-Transition Study: Objectives, Methods, and Implementation of an Innovative Planned Missing-Data Design. Am J Epidemiol. 2021 Nov 2;190(11):2262-2274. doi: 10.1093/aje/kwab141.

3D-Transition Study: Challenges and Resources of Children and Their Families During the Transition From Preschool to School, in a Pregnancy Cohort

Clinical trial NCT04873518 - References