NCT04255472 - 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)

Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B
Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33.
Sparrow, S
S., et al., Vineland adaptive behavior scales. 1984.
Varni JW, Seid M, Rode CA
The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39.
Wetherby, A
M. and B.M. Prizant, Communication and symbolic behavior scales (CSBS). 2003: Brookes Publishing Company.
World Health Organization, Mental Health Gap Action Programme (mhGAP) intervention guide for mental, neurological and substance use disorders in non-specialized health settings, in Geneva: World Health Organization
2010.

Effectiveness of the WHO Caregivers Skills Training (CST) Program for Children With Developmental Disorders and Delays in Rural Community Settings in Pakistan: An Individual Randomized Controlled Trial (RCT)

Details for clinical trial NCT04255472

Clinical trial NCT04255472 - References