- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03705208
Youth First: A Longitudinal Impact Evaluation
Long-term Evaluation of the Effects of Youth First on Social and Emotional Development, Gender Equity, and Health of Adolescents in Rural Bihar, India
연구 개요
상세 설명
This protocol is designed to answer key questions about the effects of Youth First on mental and sexual reproductive health, educational wellbeing and substance use. A mixed-methods, cluster randomized trial will assess the impact of the Youth First program over time. This component of the Youth First impact evaluation will take place across 70 schools (40 schools that are new to the Youth First intervention, 30 control schools) with 7th and 8th Standard students located within two districts in the state of Bihar, India, specifically Patna and Darbhanga.
This study will follow two cohorts of students: one of 8th Standard students and the other 7th Standard. This will include surveys conducted at baseline and at three follow-up time periods across a period of 32 months post-baseline (follow-up data collection at 8 (T1), 20 (T2), 32 (T3) months) to determine the short and long-term impact and additive effects of multiple years of Youth First. Eighth standard students will be followed through the end of 10th standard; the 7th standard cohort will be followed through the end of 9th. Both students who stay in school and those who leave will be followed up.
Quantitative data will be collected from 7th Standard (n=4500) and 8th Standard (n=3690) boys and girls across 100 schools in the two sub-studies, for a total study population of N=8190 students. Monitoring data from schools (e.g. number of sessions implemented, adherence to curriculum, etc.) collected as part of program implementation will inform a process evaluation of program quality and fidelity. Qualitative data will be collected from students after the completion of the Youth First program at the end of 8th Standard and at the end of T3.
Findings from this program are expected to provide much-needed evidence about the long-term effects of programs to address the psychosocial needs of youths in India, as well as information on the scalability of such a program within the school setting. It is expected that the findings from this study will be used by policy makers to inform decision making around the implementation of Youth First or similar programs within the state of Bihar and nationwide.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
New Delhi, 인도
- CorStone India Foundation
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All students enrolled in 7th or 8th grades at one of the schools selected for the study.
School Selection Criteria are:
- Government-run schools classified as rural and located in Darbhanga or Patna districts
- Have a minimum of 30 students enrolled in each of 7th and 8th Standards
- Have a high level of commitment from the principal to implement Youth First in both 7th and 8th grades, including willingness to have their teachers attend the training sessions and take the time to carry out the weekly sessions with the students.
- Have a high level commitment from the teachers of 7th and 8th Standards to participate in Youth First sessions, which includes taking part in all 3 trainings and holding weekly Youth First sessions.
- Have a physical space regularly available in which sessions could be held (relatively private and quiet, clean and uncluttered)
- Have a regular student teacher ratio of 50:1 or below (based on data reported in U-DISE)
- Accessible by a bus or taxi ride not greater than 3 hours from the nearest urban center.
- Classified as rural school by the Bihar Education Program Council
Exclusion Criteria:
- No exclusion criteria for students.
School exclusion criteria are:
- Have experienced a delay in starting the school year in AY2017/18.
- Have experienced extensive flooding in AY2017/18.
- Currently implementing a similar emotional resilience or life skills program in the middle school levels.
- Located in Naxal-affected area
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Youth First Curriculum
The full Youth First curriculum provides holistic training of both emotional resilience and adolescent health concepts. The curriculum is comprised of a 15-session emotional resilience curriculum and a 10-session adolescent health program. The resilience curriculum aims to increase both internal assets (such as self-esteem, coping skills, health knowledge, and conflict-resolution skills) and external assets (such as positive bonds with peers and family). The adolescent health curriculum provides in-depth training in physical health and wellness topics such as sexual and reproductive health, common diseases, nutrition, gender equality, and substance use. The curriculum is imparted by school teachers are trained and certified by CorStone. |
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
다른 이름들:
|
|
간섭 없음: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of student reporting being enrolled and regularly attending school
기간: 32 months
|
Participants are enrolled in a grade-appropriate school at the end of the study period
|
32 months
|
|
Substance use
기간: 32 months
|
Self-reported use of tobacco, alcohol or drugs.
|
32 months
|
|
Mental health
기간: 32 months
|
Strengths and Difficulties Questionnaire, internalizing problems subscale: Sum of 10 items, score range of 0-20, with lower score indicating better outcomes. KIDSCREEN psychological wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes. |
32 months
|
|
Physical Health
기간: 32 months
|
KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
|
32 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gender equitable attitudes
기간: 8, 20 and 32 months
|
Global Early Adolescent gender equity measure
|
8, 20 and 32 months
|
|
Emotional Resilience
기간: 8, 20 and 32 months
|
Connor-Davidson Resilience measure: measure of emotional resilience.
Sum of 10 items.
Scale range from 0-40.
Higher score indicates better outcomes.
|
8, 20 and 32 months
|
|
Self-efficacy
기간: 8, 20 and 32 months
|
Schwarzer's Self-Efficacy Scale: Sum of 10 items.
Scale range from 0-40.
Higher score indicates better outcome.
|
8, 20 and 32 months
|
|
Social Wellbeing
기간: 8, 20 and 32 months
|
KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
|
8, 20 and 32 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 01-YF-IN-2018-V1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Youth First Curriculum에 대한 임상 시험
-
Yonsei University아직 모집하지 않음
-
University of WashingtonNational Institute of Mental Health (NIMH); Kenyatta National Hospital; University of Nairobi...모병구현 과학 | 청소년 HIV 감염 | 구현 전략 | 성인 케어로 전환케냐
-
Children's Hospital Los AngelesAmerican Psychological Foundation모병
-
University of Missouri-ColumbiaNational PKU Alliance모병
-
Montana State University완전한
-
University of AmsterdamZonMw: The Netherlands Organisation for Health Research and Development; YIM Foundation... 그리고 다른 협력자들모병
-
University Hospital, Basel, SwitzerlandLondon School of Hygiene and Tropical Medicine; Swiss National Science Foundation; Swiss... 그리고 다른 협력자들완전한
-
Foundation for Innovative New Diagnostics, SwitzerlandMinistry of Health, Malaysia; Hospital Sultanah Bahiyah; Malaysian AIDS Council모병