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Youth First: A Longitudinal Impact Evaluation

28 de julio de 2021 actualizado por: CorStone

Long-term Evaluation of the Effects of Youth First on Social and Emotional Development, Gender Equity, and Health of Adolescents in Rural Bihar, India

This trial will assess the effect of school-based emotional resilience and health curriculum, called Youth First, on middle school students who receive the curriculum in 7th and 8th grades. Key psychosocial wellbeing, mental health, educational wellbeing and substance use measures, will be assessed longitudinally over a three year period using a cluster randomized control design.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

7762

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • India
      • New Delhi, India
        • CorStone India Foundation

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: Youth First Curriculum
A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
Otros nombres:
  • School-based emotional resilience and health curriculum
Sin intervención: School as usual
This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of student reporting being enrolled and regularly attending school
Periodo de tiempo: 32 months
Participants are enrolled in a grade-appropriate school at the end of the study period
32 months
Substance use
Periodo de tiempo: 32 months
Self-reported use of tobacco, alcohol or drugs.
32 months
Mental health
Periodo de tiempo: 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
Periodo de tiempo: 32 months
KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.
32 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gender equitable attitudes
Periodo de tiempo: 8, 20 and 32 months
Global Early Adolescent gender equity measure
8, 20 and 32 months
Emotional Resilience
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CorStone

Colaboradores

David and Lucile Packard Foundation

Investigadores

  • Investigador principal: Catherine Elkins, PhD, CorStone

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de mayo de 2018

Finalización primaria (Anticipado)

1 de agosto de 2021

Finalización del estudio (Anticipado)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

10 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

10 de octubre de 2018

Publicado por primera vez (Actual)

15 de octubre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2021

Última verificación

1 de julio de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 01-YF-IN-2018-V1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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