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A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway (COMPLETE)

Primary Purpose

Drop Out, Absence, Academic Achievement/Average Grade

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dream School Program
Mental Health Support Team
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drop Out focused on measuring randomized controlled trial, drop out, upper secondary school, psychosocial learning environments

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Dream School Program (DSP)

    DSP and Mental Health Support Team

    Control

    Arm Description

    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.

    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 Co-location of services and staff working in services "One open door" to increase accessibility to the services and staff for students Focus on the transition from lower to upper secondary school Close follow-up of students at risk to ensure tailored help to each student Early intervention and follow up when students starts being absent from school

    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.

    Outcomes

    Primary Outcome Measures

    Drop-out
    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
    Drop-out
    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
    Drop-out
    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
    Drop-out
    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
    Absence
    Total days and hours absent at closure of first school year in upper secondary school
    Absence
    Total days and hours absent at closure of second school year in upper secondary school
    Absence
    Total days and hours absent at closure of third school year in upper secondary school
    Academic achievement
    Average grade at closure of first school year in upper secondary school
    Academic achievement
    Average grade at closure of second school year in upper secondary school
    Academic achievement
    Average grade at closure of third school year in upper secondary school
    Change from baseline Mental Health at 6 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.
    Change from baseline Mental Health at 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.
    Change from baseline Mental Health at 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.
    Change in Mental Wellbeing from baseline at 6 months
    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
    Change from baseline Mental Wellbeing at 18 months
    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

    Secondary Outcome Measures

    Change from baseline School satisfaction at 6 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.
    Change from baseline School satisfaction at 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.
    Change from baseline School satisfaction at 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.
    Change from baseline Loneliness at 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.
    Change from baseline Loneliness at 18 months
    Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
    Change from baseline Loneliness at 30 months
    Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.

    Full Information

    First Posted
    November 30, 2017
    Last Updated
    March 24, 2020
    Sponsor
    University of Bergen
    Collaborators
    Oxford Research, Nordland Research Institute, Voksne for Barn, Bodin Upper Secondary School, Troms county, Nordland county, Sogn og Fjordane county, Hordaland county
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03382080
    Brief Title
    A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway
    Acronym
    COMPLETE
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    October 31, 2019 (Actual)
    Study Completion Date
    February 12, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bergen
    Collaborators
    Oxford Research, Nordland Research Institute, Voksne for Barn, Bodin Upper Secondary School, Troms county, Nordland county, Sogn og Fjordane county, Hordaland county

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drop Out, Absence, Academic Achievement/Average Grade, Mental Health
    Keywords
    randomized controlled trial, drop out, upper secondary school, psychosocial learning environments

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dream School Program (DSP)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    DSP and Mental Health Support Team
    Arm Type
    Experimental
    Arm Description
    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 Co-location of services and staff working in services "One open door" to increase accessibility to the services and staff for students Focus on the transition from lower to upper secondary school Close follow-up of students at risk to ensure tailored help to each student Early intervention and follow up when students starts being absent from school
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Dream School Program
    Other Intervention Name(s)
    Drømmeskolen (Norwegian name)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Mental Health Support Team
    Other Intervention Name(s)
    Nærværsteam (Norwegian name)
    Intervention Description
    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 Co-location of services and staff working in services "One open door" to increase accessibility to the services and staff for students Focus on the transition from lower to upper secondary school Close follow-up of students at risk to ensure tailored help to each student Early intervention and follow up when students starts being absent from school This work demands cross- and multidisciplinary collaborations within the MHST, between MHST and school leadership, and between lower and upper secondary schools.
    Primary Outcome Measure Information:
    Title
    Drop-out
    Description
    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
    Time Frame
    Each participant is assessed after 10 months
    Title
    Drop-out
    Description
    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
    Time Frame
    Each participant is assessed after 22 months
    Title
    Drop-out
    Description
    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
    Time Frame
    Each participant is assessed after 34 months
    Title
    Drop-out
    Description
    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
    Time Frame
    Each participant is assessed after 58 months
    Title
    Absence
    Description
    Total days and hours absent at closure of first school year in upper secondary school
    Time Frame
    Each participant is assessed after 10 months
    Title
    Absence
    Description
    Total days and hours absent at closure of second school year in upper secondary school
    Time Frame
    Each participant is assessed after 22 months
    Title
    Absence
    Description
    Total days and hours absent at closure of third school year in upper secondary school
    Time Frame
    Each participant is assessed after 34 months
    Title
    Academic achievement
    Description
    Average grade at closure of first school year in upper secondary school
    Time Frame
    Each participant is assessed after 10 months
    Title
    Academic achievement
    Description
    Average grade at closure of second school year in upper secondary school
    Time Frame
    Each participant is assessed after 22 months
    Title
    Academic achievement
    Description
    Average grade at closure of third school year in upper secondary school
    Time Frame
    Each participant is assessed after 34 months
    Title
    Change from baseline Mental Health at 6 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Mental Health at 18 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Mental Health at 30 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change in Mental Wellbeing from baseline at 6 months
    Description
    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
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Mental Wellbeing at 18 months
    Description
    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
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline School satisfaction at 6 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 6, 18 and 30 months
    Title
    Change from baseline School satisfaction at 18 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline School satisfaction at 30 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change from baseline Loneliness at 6 months
    Description
    Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Loneliness at 18 months
    Description
    Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Loneliness at 30 months
    Description
    Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Other Pre-specified Outcome Measures:
    Title
    Change from baseline Social competence at 6 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Social competence at 30 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change from baseline Social competence at 18 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Relatedness at 6 months
    Description
    Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Relatedness at 18 months
    Description
    Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Relatedness: support at 30 months
    Description
    Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change from baseline Relatedness: peer connection at 6 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Peer connection at 18 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Peer connection at 30 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change from baseline Autonomy support at 6 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Autonomy support at 18 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Autonomy support at 30 months
    Description
    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.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Change from baseline Academic competence at 6 months
    Description
    Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 6 months
    Title
    Change from baseline Academic competence at 18 months
    Description
    Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 18 months
    Title
    Change from baseline Academic competence at 30 months
    Description
    Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline and 30 months
    Title
    Class climate
    Description
    Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at baseline
    Title
    Change from 6 month Class climate at 18 months
    Description
    Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at 6 and 18 months
    Title
    Change from 6 month Class climate at 30 months
    Description
    Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
    Time Frame
    Based on self-report in survey assessment at 6 and 30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Torill B Larsen, PhD
    Organizational Affiliation
    University of Bergen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29523124
    Citation
    Larsen T, Urke HB, Holsen I, Anvik CH, Olsen T, Waldahl RH, Antonsen KM, Johnson R, Tobro M, Brastad B, Hansen TB. COMPLETE - a school-based intervention project to increase completion of upper secondary school in Norway: study protocol for a cluster randomized controlled trial. BMC Public Health. 2018 Mar 9;18(1):340. doi: 10.1186/s12889-018-5241-z.
    Results Reference
    derived
    Links:
    URL
    https://complete.w.uib.no/
    Description
    COMPLETE project web site

    Learn more about this trial

    A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway

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