Clinical trial NCT03455127: Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda
Official title: Community Based Lay Worker Pilot of FSI-ECD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Child Development
Home Visiting
Parenting Program
Social Protection
Public Works
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: World Bank
name: United States Agency for International Development (USAID)
name: Network of European Foundations
name: The ELMA Foundation
First posted: 2018-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Exclusion Criteria:

* Beneficiary Exclusion Criteria: Potential participants will be excluded if they do not live in chosen District of Rwanda, do not have children between the ages of 6 and 36 months living in their household for whom they are the primary caregiver, they are not eligible/enrolled in Rwanda's public works social protection program, VUP, or have severe cognitive impairments which preclude their ability to speak to the research questions under study. We will exclude families in the midst of crisis (e.g., a caregiver with active suicidal attempts or psychosis) and refer them to appropriate services.

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.

Primary outcomes:
measure: Ages Stages Questionnaire-3
timeFrame: 12 months/18 months
Secondary outcomes:
measure: Hopkins Symptoms Check List
timeFrame: 12 months/18 months
measure: Multiple Indicator Cluster Survey 5
timeFrame: 12 months/18 months
measure: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
timeFrame: 12 months/18 months
measure: Local Derived Scale
timeFrame: 12 months/18 months
measure: System for Observing Family Therapy Alliances
timeFrame: 12 months
measure: Difficulties in Emotional Regulation (DERS)
timeFrame: 12 months/18 months
measure: Malawi Development Assessment Tool (MDAT)
timeFrame: 12 months/18 months
measure: Home Observation for the Measurement of the Environment (HOME Inventory)
timeFrame: 12 months/18 months
measure: Observation of Mother Child Interaction (OMCI)
timeFrame: 12 months/18 months
measure: Ages Stages Questionnaire Socio-Emotional
timeFrame: 12 months/18 months
Other outcomes:
Locations:
city: Rubona
country: Rwanda
facility: Rwamagana District
Study officials:
affiliation: Boston College School of Social Work
name: Theresa Betancourt, Sc.D., M.A.
role: PRINCIPAL_INVESTIGATOR
References: