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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03045640
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 31, 2018
World Bank
Information provided by (Responsible Party):
Theresa Betancourt, Boston College

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.

Condition or disease Intervention/treatment Phase
Child Development Other: FSI ECD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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."
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

Primary Outcome Measures :
  1. Change: Ages and Stages Questionnaire [ Time Frame: 12 months/18 months ]
    Child development

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03045640

Sponsors and Collaborators
Boston College
World Bank
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Principal Investigator: Theresa Betancourt, Sc.D, M.A. Boston College

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Responsible Party: Theresa Betancourt, Salem Professor in Global Practice, Boston College Identifier: NCT03045640    
Other Study ID Numbers: 15440_IVC
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by Theresa Betancourt, Boston College:
parenting program
home visiting