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Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

Community Based Lay Worker Pilot of FSI-ECD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03455127
Acronym
FSI-ECD
Enrollment
90
Registered
2018-03-06
Start date
2017-03-10
Completion date
2018-03-10
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Child Development, Home Visiting, Parenting Program, Social Protection, Public Works

Brief 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.

Interventions

OTHERFSI ECD

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.

Sponsors

World Bank
CollaboratorOTHER
United States Agency for International Development (USAID)
CollaboratorFED
Network of European Foundations
CollaboratorUNKNOWN
The ELMA Foundation
CollaboratorOTHER
Boston College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No

Inclusion criteria

* Beneficiary Inclusion Criteria: All participants must live in chosen District(s) of Rwanda. Inclusion criteria for families are: (a) being VUP-eligible, (b) having at least one children aged 6-36 months living in the home and (c) having caregiver willing to discuss and enhance their parenting practices by interacting with a home-visiting coach. Caregiver eligibility: (a) is aged 18 or older and cares for child(ren) and (b) lives in the same household as child(ren). We will enroll both single and dual caregiver families to reflect population dynamics. Legal guardians may be aunts, uncles, grandparents, or foster parents. 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.

Design outcomes

Primary

MeasureTime frameDescription
Ages Stages Questionnaire-312 months/18 monthsChange in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development

Secondary

MeasureTime frameDescription
Multiple Indicator Cluster Survey 512 months/18 monthsChange in Infant and Young Child Feeding Practices
Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey12 months/18 monthsChange in Assessing Household Food Security related to diversity of food and meal frequency
Local Derived Scale12 months/18 monthsChange in Family Trust and Unity
System for Observing Family Therapy Alliances12 monthsInterventionist Self-Report
Hopkins Symptoms Check List12 months/18 monthsChange in Caregiver Mental Health
Malawi Development Assessment Tool (MDAT)12 months/18 monthsChange in Child Development Observational Measure for Fine Motor, Gross Motor and Language
Home Observation for the Measurement of the Environment (HOME Inventory)12 months/18 monthsChange in Home Environment
Observation of Mother Child Interaction (OMCI)12 months/18 monthsChange in Caregiver-Child Relationship/Stimulation
Ages Stages Questionnaire Socio-Emotional12 months/18 monthsChange in Child Socio-Emotional Development
Difficulties in Emotional Regulation (DERS)12 months/18 monthsChange in Caregiver Emotional Regulation

Countries

Rwanda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026