Child Development Clinical Trial
Official title:
Community Based Lay Worker Pilot of FSI-ECD
Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.
The Family Strengthening Intervention for early childhood development was created and piloted
for feasibility and acceptability in an ongoing protocol #15440 with Harvard Internal Review
Board titled, "Developing and Piloting a Quantitative Behavioral Assessment Battery,
Estimating Prevalence of Mental Disability among HIV/AIDS-affected Youth, and Piloting an
Adapted Mental Health Intervention for HIV/AIDS-Affected Children in Rwanda." Research
personnel have been adapting the existing recruitment materials/sessions and 15 Module Manual
(FSI-ECD) with a focus on making the manual and corresponding materials more user friendly
for community based lay worker "coaches."
This preliminary testing will provide an opportunity to administer a planned full scale
1,000+ household cluster randomized control trial on a smaller scale in order to learn from
our materials that have been adapted for community based lay workers. This will also allow us
to test our supervision and training structures to make necessary adaptation ahead of the
planned full scale trial.
After all beneficiary households have completed the FSI-ECD intervention, each community
based lay worker will complete a qualitative and quantitative exit assessment of his/her
experience delivering the intervention, as well as ongoing feedback during the administration
of FSI-ECD; allowing for the intervention and support structure to be strengthened for future
iterations.
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