Family Strengthening Intervention for Early Childhood Development (ECD)

Child Development Clinical Trial

— FSIECD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045640
• Other study ID #: 15440_IVC
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

Other:
• FSI ECD
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston College	World Bank

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change: Ages and Stages Questionnaire	Child development	12 months/18 months
Secondary	Change: Hopkins Symptoms CheckList	Caregiver Mental Health	12 months/18 months
Secondary	Change: MICS-5	Water, Sanitation, and Hygeine	12 months/18 months
Secondary	Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey	Household Food Security	12 months/18 months
Secondary	Change: Locally Derived Scale	Family Trust and Unity	12 months/18 months