Mental Health Clinical Trial
— COMPLETEOfficial 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
Verified date | March 2020 |
Source | University of Bergen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
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 |
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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