- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03045640
Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)
Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change: Ages and Stages Questionnaire
Tidsramme: 12 months/18 months
|
Child development
|
12 months/18 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change: Hopkins Symptoms CheckList
Tidsramme: 12 months/18 months
|
Caregiver Mental Health
|
12 months/18 months
|
|
Change: MICS-5
Tidsramme: 12 months/18 months
|
Water, Sanitation, and Hygeine
|
12 months/18 months
|
|
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
Tidsramme: 12 months/18 months
|
Household Food Security
|
12 months/18 months
|
|
Change: Locally Derived Scale
Tidsramme: 12 months/18 months
|
Family Trust and Unity
|
12 months/18 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Theresa Betancourt, Sc.D, M.A., Boston College
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 15440_IVC
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