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Clinical Trials/NCT03045640
NCT03045640CompletedNot Applicable

Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes

Boston College0 sites55 target enrollmentStarted: October 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Primary Endpoint
Change: Ages and Stages Questionnaire

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Months to 36 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

FSI ECD

Experimental

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."

Intervention: FSI ECD (Other)

Outcomes

Primary Outcomes

Change: Ages and Stages Questionnaire

Time Frame: 12 months/18 months

Child development

Secondary Outcomes

  • Change: Locally Derived Scale(12 months/18 months)
  • Change: Hopkins Symptoms CheckList(12 months/18 months)
  • Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey(12 months/18 months)
  • Change: MICS-5(12 months/18 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Theresa Betancourt

Salem Professor in Global Practice

Boston College

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