- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adolescence is an important developmental phase for prevention and intervention initiatives for well-being and mental health. Accordingly, school has been recommended as an optimal location for such initiatives. Universal programmes - programmes that are designated for all individuals in a population - have a number of advantages, including reducing the risk of stigma and yielding high recruitment rates.
A Lust for Life is a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents. The programme was informed by evidence-based psychological approaches including cognitive behaviour therapy, positive psychology and mindfulness and consists of six lessons, each delivered by the adolescents' school teacher on a weekly basis. The lessons involve classroom discussions, videos, classroom activities and homework assignments.
Study participants will complete the Adolescent Mental Health Continuum-Short Form, Connor-Davidson Resilience Scale-10, Emotional Literacy and Intervention Inventory-Pupil Checklist, and Mindful Attention Awareness Scale for Children at pre-intervention. Following this, schools randomly assigned to the experimental group will receive A Lust for Life, while those randomly assigned to the control group will be placed on a twelve-week waiting list. The questionnaire measures and a Brief Satisfaction Scale will be completed by participants at post-intervention. In addition, a six-week follow-up assessment will determine whether the effects of the programme are sustained over a period of time. The programme will be delivered in the waiting list control group schools after the six-week follow-up assessment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Leinster
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Dublin, Leinster, Irlanda
- University College Dublin
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adolescent
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Exclusion Criteria:
- Failure to the meet inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: A Lust for Life programme group
A Lust for Life programme will be delivered to adolescents by their school teachers in six weekly lessons.
Well-being and resilience will be promoted in each lesson through classroom discussions, videos, classroom activities and homework assignments.
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A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in adolescents.
The programme was informed by evidence-based psychological approaches including mindfulness, cognitive behaviour therapy and positive psychology.
It is delivered in six weekly lessons by the adolescents' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.
|
Otro: Waiting list control group
Participants will be placed on a twelve-week waiting list for the programme.
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Control group placed on a twelve-week waiting list.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Periodo de tiempo: 6 weeks after beginning intervention: 19/10/2020
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Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84.
Higher scores indicate lower well-being.
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6 weeks after beginning intervention: 19/10/2020
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Well-being measured by the Adolescent Mental Health Continuum-Short Form
Periodo de tiempo: 12 weeks after beginning intervention: 01/12/2020
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Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84.
Higher scores indicate lower well-being.
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12 weeks after beginning intervention: 01/12/2020
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Resilience measured by the Connor-Davidson Resilience Scale-10
Periodo de tiempo: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
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6 weeks after beginning intervention: 19/10/2020
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Resilience measured by the Connor-Davidson Resilience Scale-10
Periodo de tiempo: 12 weeks after beginning intervention: 01/12/2020
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Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
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12 weeks after beginning intervention: 01/12/2020
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Periodo de tiempo: 6 weeks after beginning intervention: 19/10/2020
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Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
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6 weeks after beginning intervention: 19/10/2020
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Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Periodo de tiempo: 12 weeks after beginning intervention: 01/12/2020
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Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
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12 weeks after beginning intervention: 01/12/2020
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Mindfulness measured by the Mindful Attention Awareness Scale for Children
Periodo de tiempo: 6 weeks after beginning intervention: 19/10/2020
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Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
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6 weeks after beginning intervention: 19/10/2020
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Mindfulness measured by the Mindful Attention Awareness Scale for Children
Periodo de tiempo: 12 weeks after beginning intervention: 01/12/2020
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Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
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12 weeks after beginning intervention: 01/12/2020
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Satisfaction with the programme measured by the Brief Satisfaction Scale
Periodo de tiempo: 6 weeks after beginning intervention: 19/10/2020
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Scores on each item of the Brief Satisfaction Scale range from 1 to 7. Higher scores indicate greater satisfaction with the programme.
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6 weeks after beginning intervention: 19/10/2020
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- moconnor1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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