- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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New Delhi, Indie
- CorStone India Foundation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Žádný zásah: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of student reporting being enrolled and regularly attending school
Časové okno: 32 months
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Participants are enrolled in a grade-appropriate school at the end of the study period
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32 months
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Substance use
Časové okno: 32 months
|
Self-reported use of tobacco, alcohol or drugs.
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32 months
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Mental health
Časové okno: 32 months
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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
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Physical Health
Časové okno: 32 months
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KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
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32 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Gender equitable attitudes
Časové okno: 8, 20 and 32 months
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Global Early Adolescent gender equity measure
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8, 20 and 32 months
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Emotional Resilience
Časové okno: 8, 20 and 32 months
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Connor-Davidson Resilience measure: measure of emotional resilience.
Sum of 10 items.
Scale range from 0-40.
Higher score indicates better outcomes.
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8, 20 and 32 months
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Self-efficacy
Časové okno: 8, 20 and 32 months
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Schwarzer's Self-Efficacy Scale: Sum of 10 items.
Scale range from 0-40.
Higher score indicates better outcome.
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8, 20 and 32 months
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Social Wellbeing
Časové okno: 8, 20 and 32 months
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KIDSCREEN Social Wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
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8, 20 and 32 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Catherine Elkins, PhD, CorStone
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 01-YF-IN-2018-V1
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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