Skip to main content
OpenTrials
Completed

NCT Number: NCT03455127

Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rwamagana District

Rubona, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FSI ECD

Other

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

Primary outcomes

  1. Ages Stages Questionnaire-3

    Time frame: 12 months/18 months

    Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development

Secondary outcomes

  1. Hopkins Symptoms Check List

    Time frame: 12 months/18 months

    Change in Caregiver Mental Health

  2. Multiple Indicator Cluster Survey 5

    Time frame: 12 months/18 months

    Change in Infant and Young Child Feeding Practices

  3. Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey

    Time frame: 12 months/18 months

    Change in Assessing Household Food Security related to diversity of food and meal frequency

  4. Local Derived Scale

    Time frame: 12 months/18 months

    Change in Family Trust and Unity

  5. System for Observing Family Therapy Alliances

    Time frame: 12 months

    Interventionist Self-Report

  6. Difficulties in Emotional Regulation (DERS)

    Time frame: 12 months/18 months

    Change in Caregiver Emotional Regulation

  7. Malawi Development Assessment Tool (MDAT)

    Time frame: 12 months/18 months

    Change in Child Development Observational Measure for Fine Motor, Gross Motor and Language

  8. Home Observation for the Measurement of the Environment (HOME Inventory)

    Time frame: 12 months/18 months

    Change in Home Environment

  9. Observation of Mother Child Interaction (OMCI)

    Time frame: 12 months/18 months

    Change in Caregiver-Child Relationship/Stimulation

  10. Ages Stages Questionnaire Socio-Emotional

    Time frame: 12 months/18 months

    Change in Child Socio-Emotional Development

Sponsors and collaborators

Lead sponsor

Boston College

Other

Collaborators

  • Network of European Foundations
  • The ELMA Foundation
  • United States Agency for International Development (USAID)
  • World Bank

Registry information

Official study title

Community Based Lay Worker Pilot of FSI-ECD

Acronym: FSI-ECD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.