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

• ClinicalTrials.gov Identifier: NCT03382080
• Recruitment Status: Completed
• First Posted: December 22, 2017
• Last Update Posted: March 25, 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
• Information provided by (Responsible Party): Torill Bogsnes Larsen, University of Bergen

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

1. Evaluate whether the DSP alone

   1. increases completion
   2. increases presence
   3. improves school achievements
   4. improves mental health and wellbeing

2. Evaluate whether the DSP and the MHST combined

   1. increase completion
   2. increase presence
   3. improve school achievements
   4. 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.

3. 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.

Condition or disease	Intervention/treatment	Phase
Drop Out; Absence; Academic Achievement/Average Grade; Mental Health	Other: Dream School Program; Other: Mental Health Support Team	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: February 1, 2016
• Actual Primary Completion Date: October 31, 2019
• Actual Study Completion Date: February 12, 2020

Arms and Interventions

Arm	Intervention/treatment
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.	Other: Dream School Program; 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 Name: Drømmeskolen (Norwegian name)
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; 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	Other: Dream School Program; 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 Name: Drømmeskolen (Norwegian name); Other: Mental Health Support Team; 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.; Other Name: Nærværsteam (Norwegian name)
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. Academic achievement [ Time Frame: Each participant is assessed after 10 months ]
   Average grade at closure of first school year in upper secondary school
9. Academic achievement [ Time Frame: Each participant is assessed after 22 months ]
   Average grade at closure of second school year in upper secondary school
10. Academic achievement [ Time Frame: Each participant is assessed after 34 months ]
    Average grade at closure of third school year in upper secondary school
11. 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.
12. 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.
13. 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.
14. 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
15. 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

Secondary Outcome Measures :

1. 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 ]
   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.
2. Change from baseline School satisfaction at 18 months [ Time Frame: 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.
3. Change from baseline School satisfaction at 30 months [ Time Frame: 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.
4. Change from baseline Loneliness at 6 months [ Time Frame: 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.
5. Change from baseline Loneliness at 18 months [ Time Frame: Based on self-report in survey assessment at baseline and 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.
6. Change from baseline Loneliness at 30 months [ Time Frame: Based on self-report in survey assessment at baseline and 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.

Other Outcome Measures:

1. Change from baseline Social competence at 6 months [ Time Frame: Based on self-report in survey assessment at baseline and 6 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.
2. Change from baseline Social competence at 30 months [ Time Frame: 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.
3. Change from baseline Social competence at 18 months [ Time Frame: 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.
4. Change from baseline Relatedness at 6 months [ Time Frame: 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.
5. Change from baseline Relatedness at 18 months [ Time Frame: Based on self-report in survey assessment at baseline and 18 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.
6. Change from baseline Relatedness: support at 30 months [ Time Frame: Based on self-report in survey assessment at baseline and 30 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.
7. Change from baseline Relatedness: peer connection at 6 months [ Time Frame: Based on self-report in survey assessment at baseline and 6 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.
8. Change from baseline Peer connection at 18 months [ Time Frame: 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.
9. Change from baseline Peer connection at 30 months [ Time Frame: Based on self-report in survey assessment at baseline and 30 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.
10. Change from baseline Autonomy support at 6 months [ Time Frame: Based on self-report in survey assessment at baseline and 6 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.
11. Change from baseline Autonomy support at 18 months [ Time Frame: Based on self-report in survey assessment at baseline and 18 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.
12. Change from baseline Autonomy support at 30 months [ Time Frame: 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.
13. Change from baseline Academic competence at 6 months [ Time Frame: Based on self-report in survey assessment at baseline and 6 months ]
    Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.
14. Change from baseline Academic competence at 18 months [ Time Frame: 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.
15. Change from baseline Academic competence at 30 months [ Time Frame: 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.
16. Class climate [ Time Frame: 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.
17. Change from 6 month Class climate at 18 months [ Time Frame: Based on self-report in survey assessment at 6 and 18 months ]
    Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.
18. Change from 6 month Class climate at 30 months [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

University of Bergen

Oxford Research

Nordland Research Institute

Voksne for Barn

Bodin Upper Secondary School

Troms county

Nordland county

Sogn og Fjordane county

Hordaland county

Investigators

• Principal Investigator: Torill B Larsen, PhD; University of Bergen

More Information

Additional Information:

COMPLETE project web site 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Torill Bogsnes Larsen, Professor, University of Bergen
• ClinicalTrials.gov Identifier: NCT03382080
• Other Study ID Numbers: 20161789
• First Posted: December 22, 2017
• Last Update Posted: March 25, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Torill Bogsnes Larsen, University of Bergen:

randomized controlled trial; drop out; upper secondary school; psychosocial learning environments

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes