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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03382080
Other study ID # 20161789
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date February 12, 2020

Study information

Verified date March 2020
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 3500
Est. completion date February 12, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (9)

Lead Sponsor Collaborator
University of Bergen Bodin Upper Secondary School, Hordaland county, Nordland county, Nordland Research Institute, Oxford Research, Sogn og Fjordane county, Troms county, Voksne for Barn

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline Social competence at 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. Based on self-report in survey assessment at baseline and 6 months
Other Change from baseline Social competence at 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. Based on self-report in survey assessment at baseline and 30 months
Other Change from baseline Social competence at 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. Based on self-report in survey assessment at baseline and 18 months
Other Change from baseline Relatedness at 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. Based on self-report in survey assessment at baseline and 6 months
Other Change from baseline Relatedness at 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. Based on self-report in survey assessment at baseline and 18 months
Other Change from baseline Relatedness: support at 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. Based on self-report in survey assessment at baseline and 30 months
Other Change from baseline Relatedness: peer connection at 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. Based on self-report in survey assessment at baseline and 6 months
Other Change from baseline Peer connection at 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. Based on self-report in survey assessment at baseline and 18 months
Other Change from baseline Peer connection at 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. Based on self-report in survey assessment at baseline and 30 months
Other Change from baseline Autonomy support at 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. Based on self-report in survey assessment at baseline and 6 months
Other Change from baseline Autonomy support at 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. Based on self-report in survey assessment at baseline and 18 months
Other Change from baseline Autonomy support at 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. Based on self-report in survey assessment at baseline and 30 months
Other Change from baseline Academic competence at 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. Based on self-report in survey assessment at baseline and 6 months
Other Change from baseline Academic competence at 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. Based on self-report in survey assessment at baseline and 18 months
Other Change from baseline Academic competence at 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. Based on self-report in survey assessment at baseline and 30 months
Other Class climate Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome. Based on self-report in survey assessment at baseline
Other Change from 6 month Class climate at 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. Based on self-report in survey assessment at 6 and 18 months
Other Change from 6 month Class climate at 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. Based on self-report in survey assessment at 6 and 30 months
Primary 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
Primary 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
Primary 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
Primary 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
Primary Absence Total days and hours absent at closure of first school year in upper secondary school Each participant is assessed after 10 months
Primary Absence Total days and hours absent at closure of second school year in upper secondary school Each participant is assessed after 22 months
Primary Absence Total days and hours absent at closure of third school year in upper secondary school Each participant is assessed after 34 months
Primary Academic achievement Average grade at closure of first school year in upper secondary school Each participant is assessed after 10 months
Primary Academic achievement Average grade at closure of second school year in upper secondary school Each participant is assessed after 22 months
Primary Academic achievement Average grade at closure of third school year in upper secondary school Each participant is assessed after 34 months
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. Based on self-report in survey assessment at baseline and 6, 18 and 30 months
Secondary 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. Based on self-report in survey assessment at baseline and 18 months
Secondary 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. Based on self-report in survey assessment at baseline and 30 months
Secondary 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. Based on self-report in survey assessment at baseline and 6 months
Secondary 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. Based on self-report in survey assessment at baseline and 18 months
Secondary 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. Based on self-report in survey assessment at baseline and 30 months
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