NCT05734547 - 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)

Cohen JA, Mannarino AP, Deblinger E
Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017
Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA
Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.
Salloum A, Scheeringa MS, Cohen JA, Storch EA
Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.

Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)

Details for clinical trial NCT05734547

Clinical trial NCT05734547 - References