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Clinical Trials/NCT03045640
NCT03045640
Completed
N/A

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

Boston College0 sites55 target enrollmentOctober 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
Boston College
Enrollment
55
Primary Endpoint
Change: Ages and Stages Questionnaire
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
September 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Theresa Betancourt

Salem Professor in Global Practice

Boston College

Eligibility Criteria

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

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)

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