Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)
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|ClinicalTrials.gov Identifier: NCT03045640|
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Child Development||Other: FSI ECD||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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."
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.
Other Name: Family Strengthening Intervention for ECD
- Change: Ages and Stages Questionnaire [ Time Frame: 12 months/18 months ]Child development
- Change: Hopkins Symptoms CheckList [ Time Frame: 12 months/18 months ]Caregiver Mental Health
- Change: MICS-5 [ Time Frame: 12 months/18 months ]Water, Sanitation, and Hygeine
- Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey [ Time Frame: 12 months/18 months ]Household Food Security
- Change: Locally Derived Scale [ Time Frame: 12 months/18 months ]Family Trust and Unity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045640
|Principal Investigator:||Theresa Betancourt, Sc.D, M.A.||Boston College|