NCT01593189 - 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)

Pears KC, Fisher PA, Heywood CV, Bronz KD
Promoting school readiness in foster children. In: Saracho ON, Spodek B, eds. Contemporary Perspectives on Social Learning in Early Childhood Education Greenwich, CT: Information Age Publishing; 2007:173-198.
Pears KC, Kim HK, Healey CV, Yoerger K, Fisher PA
Improving child self-regulation and parenting in families of pre-kindergarten children with developmental disabilities and behavioral difficulties. Prev Sci. 2015 Feb;16(2):222-32. doi: 10.1007/s11121-014-0482-2.

A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems

Clinical trial NCT01593189 - References