Clinical trial NCT03382080: A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway
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
Overall status: COMPLETED
Phase: NA
Conditions: Drop Out
Absence
Academic Achievement/Average Grade
Mental Health
Keywords: randomized controlled trial
drop out
upper secondary school
psychosocial learning environments
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Oxford Research
name: Nordland Research Institute
name: Voksne for Barn
name: Bodin Upper Secondary School
name: Troms county
name: Nordland county
name: Sogn og Fjordane county
name: Hordaland County
First posted: 2017-12-22
Enrollment: 3500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Drop-out
timeFrame: Each participant is assessed after 10 months
measure: Drop-out
timeFrame: Each participant is assessed after 22 months
measure: Drop-out
timeFrame: Each participant is assessed after 34 months
measure: Drop-out
timeFrame: Each participant is assessed after 58 months
measure: Absence
timeFrame: Each participant is assessed after 10 months
measure: Absence
timeFrame: Each participant is assessed after 22 months
measure: Absence
timeFrame: Each participant is assessed after 34 months
measure: Academic achievement
timeFrame: Each participant is assessed after 10 months
measure: Academic achievement
timeFrame: Each participant is assessed after 22 months
measure: Academic achievement
timeFrame: Each participant is assessed after 34 months
measure: Change from baseline Mental Health at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Mental Health at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Mental Health at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change in Mental Wellbeing from baseline at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Mental Wellbeing at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
Secondary outcomes:
measure: Change from baseline School satisfaction at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6, 18 and 30 months
measure: Change from baseline School satisfaction at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline School satisfaction at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change from baseline Loneliness at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Loneliness at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Loneliness at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
Other outcomes:
measure: Change from baseline Social competence at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Social competence at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change from baseline Social competence at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Relatedness at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Relatedness at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Relatedness: support at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change from baseline Relatedness: peer connection at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Peer connection at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Peer connection at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change from baseline Autonomy support at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Autonomy support at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Autonomy support at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Change from baseline Academic competence at 6 months
timeFrame: Based on self-report in survey assessment at baseline and 6 months
measure: Change from baseline Academic competence at 18 months
timeFrame: Based on self-report in survey assessment at baseline and 18 months
measure: Change from baseline Academic competence at 30 months
timeFrame: Based on self-report in survey assessment at baseline and 30 months
measure: Class climate
timeFrame: Based on self-report in survey assessment at baseline
measure: Change from 6 month Class climate at 18 months
timeFrame: Based on self-report in survey assessment at 6 and 18 months
measure: Change from 6 month Class climate at 30 months
timeFrame: Based on self-report in survey assessment at 6 and 30 months
Locations:
Study officials:
affiliation: University of Bergen
name: Torill B Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.