Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)

May 30, 2018 updated by: Theresa Betancourt, Boston College

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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."
The FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers.
Other Names:
  • Family Strengthening Intervention for ECD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change: Ages and Stages Questionnaire
Time Frame: 12 months/18 months
Child development
12 months/18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Theresa Betancourt, Sc.D, M.A., Boston College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 15440_IVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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