Drop OutCOMPLETENCT03382080
A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway
A study testing Dream School Program and Mental Health Support Team in people with Drop Out and Absence, run by University of Bergen.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drop Out, Absence, Academic Achievement/Average Grade
- What is being tested?
- Dream School Program and Mental Health Support Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Drop Out, Absence, Academic Achievement/Average Grade, Mental Health
- Being tested
- Dream School Program, Mental Health Support Team
- Keywords
- randomized controlled trial, drop out, upper secondary school, psychosocial learning environments
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dream School ProgramOther
Also called Drømmeskolen (Norwegian name)
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.
Mental Health Support TeamOther
Also called Nærværsteam (Norwegian name)
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.
| Study group | Role | What they receive |
|---|---|---|
| Dream School Program (DSP) | Experimental | 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. Receives: Other: Dream School Program |
| DSP and Mental Health Support Team | Experimental | 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
1. Co-location of services and staff working in services
2. "One open door" to increase accessibility to the services and staff for students
3. Focus on the transition from lower to upper secondary school
4. Close follow-up of students at risk to ensure tailored help to each student
5. Early intervention and follow up when students starts being absent from school Receives: Other: Dream School Program; Other: Mental Health Support Team |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Each participant is assessed after 10 months
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
Measured: Each participant is assessed after 22 months
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
Measured: Each participant is assessed after 34 months
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
Measured: Each participant is assessed after 58 months
Absence
Total days and hours absent at closure of first school year in upper secondary school
Measured: Each participant is assessed after 10 months
Absence
Total days and hours absent at closure of second school year in upper secondary school
Measured: Each participant is assessed after 22 months
Absence
Total days and hours absent at closure of third school year in upper secondary school
Measured: Each participant is assessed after 34 months
Academic achievement
Average grade at closure of first school year in upper secondary school
Measured: Each participant is assessed after 10 months
Academic achievement
Average grade at closure of second school year in upper secondary school
Measured: Each participant is assessed after 22 months
Academic achievement
Average grade at closure of third school year in upper secondary school
Measured: Each participant is assessed after 34 months
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.
Measured: Based on self-report in survey assessment at baseline and 6 months
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.
Measured: Based on self-report in survey assessment at baseline and 18 months
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.
Measured: Based on self-report in survey assessment at baseline and 30 months
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
Measured: Based on self-report in survey assessment at baseline and 6 months
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
Measured: Based on self-report in survey assessment at baseline and 18 months
Secondary outcomes (6)
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.
Measured: Based on self-report in survey assessment at baseline and 6, 18 and 30 months
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.
Measured: Based on self-report in survey assessment at baseline and 18 months
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.
Measured: Based on self-report in survey assessment at baseline and 30 months
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.
Measured: Based on self-report in survey assessment at baseline and 6 months
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.
Measured: Based on self-report in survey assessment at baseline and 18 months
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.
Measured: Based on self-report in survey assessment at baseline and 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Feb 2016
- Primary completion31 Oct 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drop OutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Research, Nordland Research Institute, Voksne for Barn, Bodin Upper Secondary School, Troms county, Nordland county, Sogn og Fjordane county, Hordaland County
- Responsible party
- Principal investigator, Torill Bogsnes Larsen, University of Bergen
- Investigators
- Torill B Larsen, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382080
- Sponsor's protocol ID
- 20161789
- Acronym
- COMPLETE
- Status last verified
- Mar 2020
- First submitted
- 30 Nov 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29523124
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03382080
- Acronym / sponsor ID
- COMPLETE / 20161789
- Conditions
- Drop Out, Absence, Academic Achievement/Average Grade, Mental Health
- Keywords
- randomized controlled trial, drop out, upper secondary school, psychosocial learning environments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Oxford Research, Nordland Research Institute, Voksne for Barn, Bodin Upper Secondary School, Troms county, Nordland county, Sogn og Fjordane county, Hordaland County
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dream School Program (DSP) | Experimental | Other: Dream School ProgramThe 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. |
| DSP and Mental Health Support Team | Experimental | Other: Dream School Program, Other: Mental Health Support TeamA 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 1. Co-location of services and staff working in services 2. "One open door" to increase accessibility to the services and staff for students 3. Focus on the transition from lower to upper secondary school 4. Close follow-up of students at risk to ensure tailored help to each student 5. Early intervention and follow up when students starts being absent from school |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dream School ProgramAlso: Drømmeskolen (Norwegian name)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. | Other | DSP and Mental Health Support Team, Dream School Program (DSP) |
| Mental Health Support TeamAlso: Nærværsteam (Norwegian name)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 1. Co-location of services and staff working in services 2. "One open door" to increase accessibility to the services and staff for students 3. Focus on the transition from lower to upper secondary school 4. Close follow-up of students at risk to ensure tailored help to each student 5. 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. | Other | DSP and Mental Health Support Team |
Primary outcome
Drop-out
Time frame: 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
Drop-out
Time frame: Each participant is assessed after 22 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
Drop-out
Time frame: Each participant is assessed after 34 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
Drop-out
Time frame: Each participant is assessed after 58 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
Absence
Time frame: Each participant is assessed after 10 months
Total days and hours absent at closure of first school year in upper secondary school
Absence
Time frame: Each participant is assessed after 22 months
Total days and hours absent at closure of second school year in upper secondary school
Absence
Time frame: Each participant is assessed after 34 months
Total days and hours absent at closure of third school year in upper secondary school
Academic achievement
Time frame: Each participant is assessed after 10 months
Average grade at closure of first school year in upper secondary school
Academic achievement
Time frame: Each participant is assessed after 22 months
Average grade at closure of second school year in upper secondary school
Academic achievement
Time frame: Each participant is assessed after 34 months
Average grade at closure of third school year in upper secondary school
Change from baseline Mental Health at 6 months
Time frame: Based on self-report in survey assessment at baseline and 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
Time frame: 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.
Change from baseline Mental Health at 30 months
Time frame: 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.
Change in Mental Wellbeing from baseline at 6 months
Time frame: Based on self-report in survey assessment at baseline and 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
Time frame: Based on self-report in survey assessment at baseline and 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
6 secondary outcomes
Change from baseline School satisfaction at 6 months
Time frame: Based on self-report in survey assessment at baseline and 6, 18 and 30 months
Change from baseline School satisfaction at 18 months
Time frame: Based on self-report in survey assessment at baseline and 18 months
Change from baseline School satisfaction at 30 months
Time frame: Based on self-report in survey assessment at baseline and 30 months
Change from baseline Loneliness at 6 months
Time frame: Based on self-report in survey assessment at baseline and 6 months
Change from baseline Loneliness at 18 months
Time frame: Based on self-report in survey assessment at baseline and 18 months
Change from baseline Loneliness at 30 months
Time frame: Based on self-report in survey assessment at baseline and 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 29523124Larsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torill B Larsen, PhD principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing Dream School Program and Mental Health Support Team in people with Drop Out and Absence, run by University of Bergen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out (time frame: Each participant is assessed after 10 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.