Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda (FSI-ECD)

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.

Study Overview

• Status: Completed
• Conditions: Child Development
• Intervention / Treatment: Other: FSI ECD

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Rubona, Rwanda
    • Rwamagana District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Classic Public Works as Usual; Half of the sample will be eligible to receive or be receiving the Government of Rwanda's (GOR) flagship social protection programming, Vision 2020 Program (VUP). One component of this program is to provide cash for work opportunities for labor endowed vulnerable households, i.e. one able bodied adult. Vulnerable households are those in Poverty Level 1 category, the GOR's poverty classification system. Furthermore, this study will require households in the control group receiving classic public works as usual to have at least one child between the ages of 6 months to 36 months.
Experimental: Classic Public Works + FSI ECD; Half of the sample will receive the FSI ECD home visiting parenting program alongside the GOR's classic public works programming. These households will be in Poverty Level 1 with an able-bodied adult, thus eligible to receive or be received the GORs public works programming. They will have a child between 6 and 36 months at enrollment. 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: FSI 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.; Other Names: Family Strengthening Intervention for ECD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ages Stages Questionnaire-3	Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development	12 months/18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Symptoms Check List	Change in Caregiver Mental Health	12 months/18 months
Multiple Indicator Cluster Survey 5	Change in Infant and Young Child Feeding Practices	12 months/18 months
Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey	Change in Assessing Household Food Security related to diversity of food and meal frequency	12 months/18 months
Local Derived Scale	Change in Family Trust and Unity	12 months/18 months
System for Observing Family Therapy Alliances	Interventionist Self-Report	12 months
Difficulties in Emotional Regulation (DERS)	Change in Caregiver Emotional Regulation	12 months/18 months
Malawi Development Assessment Tool (MDAT)	Change in Child Development Observational Measure for Fine Motor, Gross Motor and Language	12 months/18 months
Home Observation for the Measurement of the Environment (HOME Inventory)	Change in Home Environment	12 months/18 months
Observation of Mother Child Interaction (OMCI)	Change in Caregiver-Child Relationship/Stimulation	12 months/18 months
Ages Stages Questionnaire Socio-Emotional	Change in Child Socio-Emotional Development	12 months/18 months

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: United States Agency for International Development (USAID); World Bank; Network of European Foundations; The ELMA Foundation
• Investigators: Principal Investigator: Theresa Betancourt, Sc.D., M.A., Boston College School of Social Work

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): March 10, 2018
• Study Completion (Actual): March 10, 2018

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Child Development; Home Visiting; Parenting Program; Social Protection; Public Works
• Other Study ID Numbers: IRB-16 1570_Activity B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No