Family Strengthening Intervention for Early Childhood Development (ECD)

Not Applicable

Completed

• Conditions: Child Development
• Interventions: Other: FSI ECD

• Registration Number: NCT03045640
• Lead Sponsor: Boston College

Brief Summary

Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.

Detailed Description

Qualitative research from past studies was used to adapt an existing family-strengthening intervention for HIV-AIDS affected families to extremely vulnerable families with children 0-3 in order to improve early childhood development outcomes. This small scale pilot was carried out to test the feasibility and acceptability of the intervention for extremely vulnerable families with young children in Rwanda.

In the first 10 families the intervention consisted of 21 modules, in the second iteration of the study with an additional 10 families, the curriculum was summarized into 15 modules. Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and were delivered to families one on one in their respective homes. Modules were delivered on a weekly to biweekly basis and were flexible to the families needs and other responsibilities.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Potential participants must live in the study catchment area
• Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
• We will enroll both single and dual caregiver families to reflect population dynamics.
• Legal guardians may be aunts, uncles, grandparents, or foster parents

Exclusion Criteria

• Potential participants that do not live in the study catchment area
• Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
• Are not classified as Ubudehe 1 or 2
• Have severe cognitive impairments which preclude their ability to speak to the research questions under study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FSI ECD	FSI ECD	Vulnerable Households (ubudehe 1 or 2) in the Government of Rwanda's poverty classification system, when categories ranged from 1 to 6; the system has since been restructured to have four categories only. Often a way to identify households for public works opportunities or other government assistance programs. For this arm, families had to be Ubudehe 1 or 2 and have a child aged 0-3 years. Households meeting these criteria in the catchment area(s) received the FSI ECD home-based parenting intervention from bachelor-level interventionists/"coaches."

Primary Outcome Measures

Name	Time	Method
Change: Ages and Stages Questionnaire	12 months/18 months	Child development

Secondary Outcome Measures

Name	Time	Method
Change: MICS-5	12 months/18 months	Water, Sanitation, and Hygeine
Change: Locally Derived Scale	12 months/18 months	Family Trust and Unity
Change: Hopkins Symptoms CheckList	12 months/18 months	Caregiver Mental Health
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey	12 months/18 months	Household Food Security