- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03045640
Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)
Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change: Ages and Stages Questionnaire
Periodo de tiempo: 12 months/18 months
|
Child development
|
12 months/18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change: Hopkins Symptoms CheckList
Periodo de tiempo: 12 months/18 months
|
Caregiver Mental Health
|
12 months/18 months
|
|
Change: MICS-5
Periodo de tiempo: 12 months/18 months
|
Water, Sanitation, and Hygeine
|
12 months/18 months
|
|
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
Periodo de tiempo: 12 months/18 months
|
Household Food Security
|
12 months/18 months
|
|
Change: Locally Derived Scale
Periodo de tiempo: 12 months/18 months
|
Family Trust and Unity
|
12 months/18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Theresa Betancourt, Sc.D, M.A., Boston College
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 15440_IVC
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