Condition category
Mental and Behavioural Disorders
Date applied
16/07/2015
Date assigned
17/08/2015
Last edited
26/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and aims
This three-year trial will evaluate the effectiveness of a universal primary school based program called MV-2 (Mitt Valg 2, grades 5-7) in Norway (the original US version is termed the Lions-Quest ”Skills for Adolescence” [grades 6-8] program). MV-2 is aimed towards helping students achieve and perform essential social and emotional skills. The program is called universal because all students in a class receive the program at the same time, and preferably all classes in one school should receive MV-2. MV-2 is supported by two studies in the US, but currently lacks a strong evidence base. MV-2 does, however, belong to the family of programs referred to as Social and Emotional Learning (SEL) programs, with more than 20 years of research behind them. It is thought that that MV-2 can have a beneficial and meaningful effect on students’ social and emotional behavior as well as on their self-esteem. MV-2 is made up of 47 lessons organized in six themes: development of the school climate, social interaction and emotions, relations, critical thinking, drugs and tobacco, and formulating positive goals. The current trial is important because there is a significant number of children and young people who suffer from emotional and social difficulties. Furthermore, in many Norwegian schools, whole school models are implemented, aiming to improve the whole school environment/climate as well as students’ skills. Incorporated into those models are universal programs aiming to work with students’ social skills, for example, Second Step and Zippy’s friends. Expanding the scope of universal programs that can be incorporated into whole school models may help disseminating models to more Norwegian schools. The main aim is to examine the impact of the MV-2 on Norwegian students’ social skills and emotional wellbeing.

Who can participate?
Schools who have not systematically implemented a universal program aimed towards students’ social and emotional (such as Second Step, Zippy’ Friends, MV-2) since the school year of 2012-2013. Students taking part will be in Year 5.

What does the study involve?
Participating schools are randomly allocated to either an experiment group or a wait list control group. For the schools in the experimental group, teachers receive a two-day workshop whereby they learn to implement MV-2. These teachers are then be expected to deliver classrooms lessons at least once a week over a two-year period. Teachers in the schools allocated to the wait list control group receive the same 2-day workshop one year after teachers in the experiment group schools. Data will be collected from the students in the classes just before the teachers attend the workshop, then after they have participated in MV-2 classes for one year, and again, when they have participated in MV-2 classes for two years. The current trial involves evaluating MV-2 “as is”, i.e. the way it is currently carried out in Norwegian schools. This involves the two-day workshop to teachers, which is led by instructors certified by Lions Club. After the 2-day course there is usually no supervision from the instructors, but there is a one-day voluntary brush-up workshop available. During the current trial data on teachers implementation of MV-2 is collected, including amount and regularity of lesson delivered, lesson duration and planning time, lesson content and structure adherence, and student engagement during lesson delivery

What are the possible benefits and risks of participating?
The MV-2 program has been used for a more than a decade in Norwegian schools along with other universal programs aiming to teach social and emotional skills. MV-2 is also recommended by the Norwegian educational authorities and supported by the Norwegian health authorities. During this period there has not been any adverse effects or risks discovered. Any ethical considerations, therefore, can be inferred from the current research design. As the current trial employs a randomization design, each student is not in a position to choose to receive MV-2 or not, the randomization unit is the school, and all students receive MV-2 as it is a universal program with lessons performed in the classroom. This does not, however, constitute an ethical problem; it is quite common in schools that students have little influence over topics and lessons taught in class during the school year. The students and their parents will receive information about the research part of the trial, namely the student surveys. Parents may excuse their children from participating in the survey, and each student can also refuse to participate in the survey. The paper-based survey will be filled out with a pen at school during class, and it will not contain any identifying information about the student, only gender and class grade (Year 5, 6 or 7). The teacher surveys will be performed by means of an electronic survey, containing person-identifying information. It will not, however, contain any identifying information about students or colleagues. Due to the person-identification, the trial is reported to the Norwegian Data Protection Official for Research.

Where is the study run from?
Oslo and Akershus University College of Applied Sciences (Norway)

When is the study starting and how long is it expected to run for?
November 2015 to December 2017.

Who is funding the study?
The trial is funded by the “Det er Mitt Valg” foundation, which is a part of the Lions Club Norway.

Who is the main contact?
Dr Børge Strømgren
Borge.Stromgren@hioa.no

Trial website

Contact information

Type

Scientific

Primary contact

Dr Borge Stromgren

ORCID ID

http://orcid.org/0000-0001-7841-5693

Contact details

Oslo and Akershus University College of Applied Sciences
Post box 4 St. Olavs plass
Oslo
0130
Norway
+47 97424499
Borge.Stromgren@hioa.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation the efficacy of the Norwegian version of the Lions-Quest ”Skills for Adolescence” program “Mitt Valg 2”: a cluster randomized controlled trial with a wait-list control

Acronym

Study hypothesis

The primary aim of the proposed research is to examine the impact of the Loins-Quest “Skills for Adolescence” (the Norwegian version is termed MV-2 for the current trial) program on the emotional and social wellbeing in Norwegian primary schools through a three-year wait-list control cluster randomized controlled trial. The aim will be achieved by addressing the following objectives:
1. To determine the effect of MV-2 on a variety of primary and secondary outcomes for children and teachers

Student outcomes:
Hypothesis 1: Students in experiment group schools; i.e. delivering MV-2 from day one (after T1), will after a one-year period (at T2) report significant improvements in the following primary outcomes:
1.1 Emotional wellbeing and problem behavior
1.2 Social and emotional skills
1.3 Self-Esteem
Hypothesis 2: The reported primary outcomes listed under hypothesis 1 will be sustained or improved after two years (T3)
Hypothesis 3: Students in wait-list control schools: i.e. delivering MV-2 one year after experiment group schools (after T2), will at T2 not report significant improvement in the primary outcomes listed in hypothesis 1
Hypothesis 4: After three years (at T3) students in the wait-list control group will report similar effects in primary outcomes as students in hypothesis 1
Hypothesis 5: The hypotheses 1 to 4 will be equally applicable to the secondary student outcomes:
5.1. Student-Student relations and Student-Teacher relations, and norms toward school
5.2. Bullying and Victimization

Teacher outcomes:
Hypothesis 6: Teachers in experiment group schools; i. e. delivering MV-2 from day one (after T1), will after a one-year period (at T2) report significant improvements in the following primary outcomes:
6.1 Students social skills and school engagement
6.3 Students problem behavior in the classroom and school environment
Hypothesis 7: The primary outcomes listed under hypothesis 6 will be sustained or improved after two years (at T3)
Hypothesis 8: Teachers in wait-list control schools: i.e. delivering MV-2 one year after experiment group schools (after T2), will at T2 not report significant improvements in the primary outcomes listed in hypothesis 6
Hypothesis 9: After three years (at T3) teachers in the wait-list control group will report similar effects in the primary outcomes as students in hypothesis 6
Hypothesis 10: The hypotheses 6 to 9 will be equally applicable to the secondary teacher outcome school climate

Implementation variability:
Hypothesis 11: The quality of the implementation of MV-2 will be associated with variability of the outcomes listed in hypotheses 1 to 10. Implementation quality variables will be:
11.1. Amount and regularity of lesson delivered
11.2. Lesson duration and planning time
11.3. Lesson content and structure adherence
11.4. Student engagement during lesson delivery

Ethics approval

Norwegian Data Protection Official for Research, 23/06/2015, ref: 43838

Study design

Single-center cluster-randomized controlled trial with a wait list control

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Norwegian versions (only) of the information material may be collected by contacting the main contact: Borge.Stromgren@hiao.no

Condition

Social and emotional skills and emotional wellbeing

Intervention

MV-2 (the Norwegian version of the original US version termed the Lions-Quest ”Skills for Adolescence” [grades 6-8] program) is a universal and curriculum based SEL-recommended program for students in the school Years 5-7 (http://secondaryguide.casel.org). The program is developmentally sequenced as well as adopted to the Norwegian educational authorities commitment initiative called “The Knowledge Promotion.” The MV-2 school manual consists of 47 lessons organized in 6 themes:
1. Development of a positive school climate,
2. Social interaction and emotions,
3. Relations,
4. Critical thinking,
5. Drugs and tobacco
6. Formulating positive goals

Lessons are organized according to scientific criteria practices (SAFE: Sequenced, Active, Focused, Explicit) and consist of three phases:
1. Explore
2. Experience
3. Expand

Some lessons contain homework assignments; therefore a pacing with a new lesson every other week seems reasonable in order to cover the whole curriculum during the Years 5-7, making it possible to deliver 16 lessons in Year 5, 16 lessons in Year 6, and 15 lessons in Year 7. It is also possible to work with lessons every day for a shorter period of time, thereby compressing the delivery of the program to 6 weeks during each school year. The actual organizing of the lesson delivery is for each school to decide. Although the current trial focuses on the MV-2 manual for the school and the school delivery, there also exists information material and activity suggestions for parents. Again, it is up to each school to decide whether information to and cooperation with parents will be included,
Lesson pacing and delivery organization, as well as parental cooperation, will be a comparator between implementing schools.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Students:
1. Strengths and Difficulties Questionnaire (SDQ): it provides measures of emotional difficulties, conduct problems, hyperactivity/inattention, peer problems and pro-social behavior. It is widely used internationally
2. Social Emotional Assets and Resilience Scales–Children Short Form (SEARS-CSF): it provides measures of core SEL-competencies such as self-awareness, self-management, social awareness, relationship skills, and responsible decision-making
3. Coopersmith Self-Esteem Inventor–School Short Form (CSEI-SSF): it provides measures of a core SEL-competency such as self-esteem, both general and with peers

Teachers:
1. A self-developed screening scale that provides information about students’ pro-social competencies and engagement in school activities. It is inspired by the the SSIS Performance Screening Guide
2. Problem behaviors in school (PBS): it provides information about how often the teachers’ had to manage problem behaviors in the classroom and school environment during the last week

Data will be collected from the students in the classes just before the teachers attend the workshop, then after they have participated in MV-2 classes for one year, and again, when they have participated in MV-2 classes for two years.

Secondary outcome measures

Students:
1. School climate (SC): it provides information about the perceived school climate and contains scales covering relations between students, school norms among students, and emotional support from teachers/ student-teacher relations
2. Bullying and victimization (from the Olweus Bullying Questionnaire-Revised): it provides information about how often the students have been bullying or victimized during the last couple of months

Teachers:
1. School environment-Openness in communication: it provides information about teachers’ perception of the openness in communication at their school, and has shown to be a predictor of implementation quality

Data will be collected from the students in the classes just before the teachers attend the workshop, then after they have participated in MV-2 classes for one year, and again, when they have participated in MV-2 classes for two years.

Overall trial start date

01/11/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Students in Years 5, 6, and 7, in schools eligible to participate
2. All full time students in participating schools will be considered as potential participants
3. Parental consent will be based upon information letters to parents prior to the data survey, which informs parents that they may excuse their child from participating in the survey

Participant type

All

Age group

Child

Gender

Both

Target number of participants

The targeted number of participants will be 56 schools, with approximately 50 students at each school in Year 5 (and later 6 and 7), yielding a total number of 2800 students.

Participant exclusion criteria

Students in schools that do not meet the inclusion criteria

Recruitment start date

01/11/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo and Akershus University College of Applied Sciences
Post box 4 St. Olavs plass
Oslo
0130
Norway

Sponsor information

Organisation

Oslo and Akershus University College of Applied Sciences

Sponsor details

Post box 4 St. Olavs plass
Oslo
0130
Norway
+47 97424499
Borge.Stromgren@hioa.no

Sponsor type

University/education

Website

http://www.hioa.no

Funders

Funder type

Research organisation

Funder name

“Det er Mitt Valg” Foundation, part of the Lions Club Norway.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan is to publish the results in international peer reviewed journals, preferably journals publishing in the area of school psychology, implementation, universal and primary prevention. The goal is to publish three to five articles by the end of 2019 with the following focus:
1. The effect of MV-2 after one year
2. The effect of MV-2 after two years
3. The effect of moderators and implementation

Intention to publish date

30/03/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2015: Recruitment dates have been updated from 01/09/2015-01/10/2015 to 01/11/2015-01/12/2015.