- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03045640
Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)
Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change: Ages and Stages Questionnaire
Délai: 12 months/18 months
|
Child development
|
12 months/18 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change: Hopkins Symptoms CheckList
Délai: 12 months/18 months
|
Caregiver Mental Health
|
12 months/18 months
|
|
Change: MICS-5
Délai: 12 months/18 months
|
Water, Sanitation, and Hygeine
|
12 months/18 months
|
|
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
Délai: 12 months/18 months
|
Household Food Security
|
12 months/18 months
|
|
Change: Locally Derived Scale
Délai: 12 months/18 months
|
Family Trust and Unity
|
12 months/18 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Theresa Betancourt, Sc.D, M.A., Boston College
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 15440_IVC
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .