- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03045640
Family Strengthening Intervention for Early Childhood Development (ECD) (FSIECD)
Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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."
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change: Ages and Stages Questionnaire
기간: 12 months/18 months
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Child development
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12 months/18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change: Hopkins Symptoms CheckList
기간: 12 months/18 months
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Caregiver Mental Health
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12 months/18 months
|
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Change: MICS-5
기간: 12 months/18 months
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Water, Sanitation, and Hygeine
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12 months/18 months
|
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Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
기간: 12 months/18 months
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Household Food Security
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12 months/18 months
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Change: Locally Derived Scale
기간: 12 months/18 months
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Family Trust and Unity
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12 months/18 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
아동 발달에 대한 임상 시험
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Boehringer Ingelheim더 이상 사용할 수 없음폐 질환, 간질(소아 집단에서) | 소아 간질성 폐질환(chILD)
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MindRank AI Ltd아직 모집하지 않음경증 및 중등증의 간 장애 (Child-Pugh 등급 A 및 B) | 간 기능 부전 (MeSH ID: D048550)중국
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FSI ECD에 대한 임상 시험
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Boston CollegeUnited States Agency for International Development (USAID); World Bank; Network of European... 그리고 다른 협력자들완전한
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Elizabeth Glaser Pediatric AIDS FoundationAga Khan University; Development Media International; Ministry of Health, Community Development... 그리고 다른 협력자들완전한
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EarliTec Diagnostics, IncMarcus Autism Center완전한
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VA Office of Research and DevelopmentUniversity of Colorado, Denver완전한
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Rahel NaefSwiss National Science Foundation완전한
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Harvard School of Public Health (HSPH)Boston Children's Hospital; Harvard University; Partners in Health완전한
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Johns Hopkins Bloomberg School of Public Health완전한조기 아동 발달(ECD)
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Boston UniversityUnited States Agency for International Development (USAID); Swiss Tropical & Public Health... 그리고 다른 협력자들완전한