Rwamagana District
Rubona, Rwanda
NCT Number: NCT03455127
Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.
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Notify Me6 month–36 month
All sexes
Interventional
Not applicable
Rubona, Rwanda
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Community Based Lay Worker Exclusion Criteria: Community based workers selected to deliver the FSI-ECD intervention must: (a) live in the sector of beneficiary households they will deliver the intervention to, (b) be Rwanda, (c) be aged 18 or older; (d) be able to write, read, and count in local language; (e) be committed to young children and family values; (f) have the required amount of time to carry out the FSI-ECD intervention with a select number of households, (e) be recommended and approved by local community and authorities.
Exclusion criteria
Community Based Lay Worker Exclusion Criteria: Community based workers will not be selected to deliver the FSI-ECD intervention if they do/are not: (a) live in the sector of beneficiary households they will deliver the intervention to, (b) Rwanda, (c) aged 18 or older; (d) able to write, read, and count in local language; (e) committed to young children and family values; (f) have required amount of time to carry out the FSI-ECD intervention with a select number of households, (e) recommended and approved by local community and authorities.
Households 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.
Other names: Family Strengthening Intervention for ECD
Time frame: 12 months/18 months
Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development
Time frame: 12 months/18 months
Change in Caregiver Mental Health
Time frame: 12 months/18 months
Change in Infant and Young Child Feeding Practices
Time frame: 12 months/18 months
Change in Assessing Household Food Security related to diversity of food and meal frequency
Time frame: 12 months/18 months
Change in Family Trust and Unity
Time frame: 12 months
Interventionist Self-Report
Time frame: 12 months/18 months
Change in Caregiver Emotional Regulation
Time frame: 12 months/18 months
Change in Child Development Observational Measure for Fine Motor, Gross Motor and Language
Time frame: 12 months/18 months
Change in Home Environment
Time frame: 12 months/18 months
Change in Caregiver-Child Relationship/Stimulation
Time frame: 12 months/18 months
Change in Child Socio-Emotional Development
Boston College
Other
Community Based Lay Worker Pilot of FSI-ECD
Acronym: FSI-ECD
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