A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway (COMPLETE)
24 de marzo de 2020 actualizado por: Torill Bogsnes Larsen, University of Bergen
COMPLETE - a School-based Intervention Project to Improve Psychosocial Learning Environments and Increase Completion of Upper Secondary School in Norway: a Cluster Randomized Controlled Trial
Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence.
Specifically, the COMPLETE study will
Evaluate whether the DSP alone
- increases completion
- increases presence
- improves school achievements
- improves mental health and wellbeing
Evaluate whether the DSP and the MHST combined
- increase completion
- increase presence
- improve school achievements
- improve mental health and wellbeing
The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness.
- Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
3500
Fase
- No aplica
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
15 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- School inclusion criteria: not been or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects
- Student inclusion criteria: student enrolled at any of the included schools.
Exclusion Criteria:
- Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects.
- Student exclusion criteria: students with special needs or who are illiterate in Norwegian are excluded from the survey assessment, but included in the interventions.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dream School Program (DSP)
The Dream School Program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted.
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The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted.
Otros nombres:
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Experimental: DSP and Mental Health Support Team
A combination of the universal Dream Schoop Program (see description above) and the selective/indicative intervention Mental Health Support Team which is aimed at specific students at risk of dropping out of upper secondary school. It is a systematization of the student services through
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The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted.
Otros nombres:
MHST is also a whole school project but aimed at specific students at risk of dropping out. It is a systematisation of the student services through
Otros nombres:
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Sin intervención: Control
The control group are upper secondary schools who run classes and the school as usual, and do not introduce new programs similar to the Dream School or Mental Health Support Team during the project period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Drop-out
Periodo de tiempo: Each participant is assessed after 10 months
|
If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school
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Each participant is assessed after 10 months
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Drop-out
Periodo de tiempo: Each participant is assessed after 22 months
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If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school
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Each participant is assessed after 22 months
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Drop-out
Periodo de tiempo: Each participant is assessed after 34 months
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If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school
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Each participant is assessed after 34 months
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Drop-out
Periodo de tiempo: Each participant is assessed after 58 months
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If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school
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Each participant is assessed after 58 months
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Absence
Periodo de tiempo: Each participant is assessed after 10 months
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Total days and hours absent at closure of first school year in upper secondary school
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Each participant is assessed after 10 months
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Absence
Periodo de tiempo: Each participant is assessed after 22 months
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Total days and hours absent at closure of second school year in upper secondary school
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Each participant is assessed after 22 months
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Absence
Periodo de tiempo: Each participant is assessed after 34 months
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Total days and hours absent at closure of third school year in upper secondary school
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Each participant is assessed after 34 months
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Academic achievement
Periodo de tiempo: Each participant is assessed after 10 months
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Average grade at closure of first school year in upper secondary school
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Each participant is assessed after 10 months
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Academic achievement
Periodo de tiempo: Each participant is assessed after 22 months
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Average grade at closure of second school year in upper secondary school
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Each participant is assessed after 22 months
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Academic achievement
Periodo de tiempo: Each participant is assessed after 34 months
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Average grade at closure of third school year in upper secondary school
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Each participant is assessed after 34 months
|
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Change from baseline Mental Health at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Mental Health at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
|
Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Mental Health at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
|
Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.
|
Based on self-report in survey assessment at baseline and 30 months
|
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Change in Mental Wellbeing from baseline at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Mental Wellbeing at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
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Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome
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Based on self-report in survey assessment at baseline and 18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline School satisfaction at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6, 18 and 30 months
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Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale.
5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6, 18 and 30 months
|
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Change from baseline School satisfaction at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
|
Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale.
5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.
|
Based on self-report in survey assessment at baseline and 18 months
|
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Change from baseline School satisfaction at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
|
Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale.
5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.
|
Based on self-report in survey assessment at baseline and 30 months
|
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Change from baseline Loneliness at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
|
Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Loneliness at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
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Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Loneliness at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
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Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
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Based on self-report in survey assessment at baseline and 30 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline Social competence at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Social competence at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
|
Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 30 months
|
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Change from baseline Social competence at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
|
Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Relatedness at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
|
Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Relatedness at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
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Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Relatedness: support at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
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Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 30 months
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Change from baseline Relatedness: peer connection at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Peer connection at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
|
Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Peer connection at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
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Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 30 months
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Change from baseline Autonomy support at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6 months
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Change from baseline Autonomy support at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
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Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 18 months
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Change from baseline Autonomy support at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
|
Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 30 months
|
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Change from baseline Academic competence at 6 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 6 months
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Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline and 6 months
|
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Change from baseline Academic competence at 18 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 18 months
|
Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
|
Based on self-report in survey assessment at baseline and 18 months
|
|
Change from baseline Academic competence at 30 months
Periodo de tiempo: Based on self-report in survey assessment at baseline and 30 months
|
Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
|
Based on self-report in survey assessment at baseline and 30 months
|
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Class climate
Periodo de tiempo: Based on self-report in survey assessment at baseline
|
Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at baseline
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Change from 6 month Class climate at 18 months
Periodo de tiempo: Based on self-report in survey assessment at 6 and 18 months
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Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at 6 and 18 months
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Change from 6 month Class climate at 30 months
Periodo de tiempo: Based on self-report in survey assessment at 6 and 30 months
|
Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
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Based on self-report in survey assessment at 6 and 30 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Torill B Larsen, PhD, University of Bergen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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)
1 de febrero de 2016
Finalización primaria (Actual)
31 de octubre de 2019
Finalización del estudio (Actual)
12 de febrero de 2020
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
18 de diciembre de 2017
Publicado por primera vez (Actual)
22 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
24 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20161789
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .