NCT01720199 - 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)

Ajzen, I
(1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
Bandura, A
(1977). Social Learning Theory. New York: General Learning Press.
Bandura, A
(1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
Dodge, K
A., Coie, J.D., & Lynam, D. (2006). Aggression and antisocial behavior in youth. In W. Damon (Series Ed.), & N. Eisenberg (Vol. Ed.) (Ed.). Handbook of Child Psychology, Vol. 3: Social, Emotional, and Personality Development6th edition (pp. 719-788). Wiley.
Galanti MR, Siliquini R, Cuomo L, Melero JC, Panella M, Faggiano F; EU-DAP study group
Testing anonymous link procedures for follow-up of adolescents in a school-based trial: the EU-DAP pilot study. Prev Med. 2007 Feb;44(2):174-7. Epub 2006 Sep 18.
Gardner, H
(1987). Beyond a modular view of mind. In W. Damon (Ed.), New Directions for Child Development, Tenth Anniversary Edition. Also in W. Damon (Ed.) (1988), Child Development Today and Tomorrow (222-239). San Francisco: Jossey-Bass.
Goleman, D
(1998). Working with emotional intelligence. New York: Bantam.
Prochaska J
O. and DiClemente C.C. (1982). Trans-theoretical therapy - toward a more integrative model of change. Psychotherapy: Theory, Research and Practice 19(3):276-288
Prochaska JO, DiClemente CC, Norcross JC
In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14.

Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)

Clinical trial NCT01720199 - References