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Completed

NCT Number: NCT03045640

Family Strengthening Intervention for Early Childhood Development (ECD)

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

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Key information

Conditions

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

FSI ECD

Other

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

Primary outcomes

  1. Change: Ages and Stages Questionnaire

    Time frame: 12 months/18 months

    Child development

Secondary outcomes

  1. Change: Hopkins Symptoms CheckList

    Time frame: 12 months/18 months

    Caregiver Mental Health

  2. Change: MICS-5

    Time frame: 12 months/18 months

    Water, Sanitation, and Hygeine

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

    Time frame: 12 months/18 months

    Household Food Security

  4. Change: Locally Derived Scale

    Time frame: 12 months/18 months

    Family Trust and Unity

Sponsors and collaborators

Lead sponsor

Boston College

Other

Collaborators

  • World Bank

Registry information

Official study title

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

Acronym: FSIECD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2017
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.

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