NCT03382080

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. 1.Evaluate whether the DSP alone
  2. 2.increases completion
  3. 3.increases presence
  4. 4.improves school achievements
  5. 5.improves mental health and wellbeing
  6. 6.Evaluate whether the DSP and the MHST combined
  7. 7.increase completion
  8. 8.increase presence
  9. 9.improve school achievements
  10. 10.improve mental health and wellbeing
  11. 11.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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

November 30, 2017

Last Update Submit

March 24, 2020

Conditions

Keywords

randomized controlled trialdrop outupper secondary schoolpsychosocial learning environments

Outcome Measures

Primary Outcomes (15)

  • 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

    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

    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

    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

    Each participant is assessed after 58 months

  • Absence

    Total days and hours absent at closure of first school year in upper secondary school

    Each participant is assessed after 10 months

  • Absence

    Total days and hours absent at closure of second school year in upper secondary school

    Each participant is assessed after 22 months

  • Absence

    Total days and hours absent at closure of third school year in upper secondary school

    Each participant is assessed after 34 months

  • Academic achievement

    Average grade at closure of first school year in upper secondary school

    Each participant is assessed after 10 months

  • Academic achievement

    Average grade at closure of second school year in upper secondary school

    Each participant is assessed after 22 months

  • Academic achievement

    Average grade at closure of third school year in upper secondary school

    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.

    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.

    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.

    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

    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

    Based on self-report in survey assessment at baseline and 18 months

Secondary Outcomes (6)

  • Change from baseline School satisfaction at 6 months

    Based on self-report in survey assessment at baseline and 6, 18 and 30 months

  • Change from baseline School satisfaction at 18 months

    Based on self-report in survey assessment at baseline and 18 months

  • Change from baseline School satisfaction at 30 months

    Based on self-report in survey assessment at baseline and 30 months

  • Change from baseline Loneliness at 6 months

    Based on self-report in survey assessment at baseline and 6 months

  • Change from baseline Loneliness at 18 months

    Based on self-report in survey assessment at baseline and 18 months

  • +1 more secondary outcomes

Other Outcomes (18)

  • Change from baseline Social competence at 6 months

    Based on self-report in survey assessment at baseline and 6 months

  • Change from baseline Social competence at 30 months

    Based on self-report in survey assessment at baseline and 30 months

  • Change from baseline Social competence at 18 months

    Based on self-report in survey assessment at baseline and 18 months

  • +15 more other outcomes

Study Arms (3)

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.

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

Other: Dream School ProgramOther: 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.

Interventions

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.

Also known as: Drømmeskolen (Norwegian name)
DSP and Mental Health Support TeamDream School Program (DSP)

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.

Also known as: Nærværsteam (Norwegian name)
DSP and Mental Health Support Team

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Torill B Larsen, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 22, 2017

Study Start

February 1, 2016

Primary Completion

October 31, 2019

Study Completion

February 12, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03