Clinical Trials Directory

Trials / Completed

CompletedNCT03455127

Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

Community Based Lay Worker Pilot of FSI-ECD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Boston College · Academic / Other
Sex
All
Age
6 Months – 36 Months
Healthy volunteers
Not accepted

Summary

Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERFSI ECDHouseholds will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.

Timeline

Start date
2017-03-10
Primary completion
2018-03-10
Completion
2018-03-10
First posted
2018-03-06
Last updated
2018-05-31

Locations

1 site across 1 country: Rwanda

Source: ClinicalTrials.gov record NCT03455127. Inclusion in this directory is not an endorsement.