NCT02510313 - 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)

Betancourt TS, Ng LC, Kirk CM, Munyanah M, Mushashi C, Ingabire C, Teta S, Beardslee WR, Brennan RT, Zahn I, Stulac S, Cyamatare FR, Sezibera V
Family-based prevention of mental health problems in children affected by HIV and AIDS: an open trial. AIDS. 2014 Jul;28 Suppl 3:S359-68. doi: 10.1097/QAD.0000000000000336.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C
Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
Dyregrov A, Gupta L, Gjestad R, Mukanoheli E
Trauma exposure and psychological reactions to genocide among Rwandan children. J Trauma Stress. 2000 Jan;13(1):3-21.
Shonkoff JP
Building a new biodevelopmental framework to guide the future of early childhood policy. Child Dev. 2010 Jan-Feb;81(1):357-67. doi: 10.1111/j.1467-8624.2009.01399.x.

Effectiveness Trial of a Family Home Visiting Intervention to Promote Early Child Development Among Families Served by the Social Protection System in Rwanda

Details for clinical trial NCT02510313

Clinical trial NCT02510313 - References