Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

Child Development Clinical Trial

— FSI-ECD  

Official title:

Community Based Lay Worker Pilot of FSI-ECD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455127
• Other study ID #: IRB-16 1570_Activity B
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: May 2018
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 10, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Child Development

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Rwamagana District	Rubona

Sponsors (5)

Lead Sponsor	Collaborator
Boston College	ELMA Philanthropies, Network of European Foundations, United States Agency for International Development (USAID), World Bank

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ages Stages Questionnaire-3	Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development	12 months/18 months
Secondary	Hopkins Symptoms Check List	Change in Caregiver Mental Health	12 months/18 months
Secondary	Multiple Indicator Cluster Survey 5	Change in Infant and Young Child Feeding Practices	12 months/18 months
Secondary	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
Secondary	Local Derived Scale	Change in Family Trust and Unity	12 months/18 months
Secondary	System for Observing Family Therapy Alliances	Interventionist Self-Report	12 months
Secondary	Difficulties in Emotional Regulation (DERS)	Change in Caregiver Emotional Regulation	12 months/18 months
Secondary	Malawi Development Assessment Tool (MDAT)	Change in Child Development Observational Measure for Fine Motor, Gross Motor and Language	12 months/18 months
Secondary	Home Observation for the Measurement of the Environment (HOME Inventory)	Change in Home Environment	12 months/18 months
Secondary	Observation of Mother Child Interaction (OMCI)	Change in Caregiver-Child Relationship/Stimulation	12 months/18 months
Secondary	Ages Stages Questionnaire Socio-Emotional	Change in Child Socio-Emotional Development	12 months/18 months