Condition category
Mental and Behavioural Disorders
Date applied
07/10/2019
Date assigned
05/01/2020
Last edited
02/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
RefugeesWellSchool is a European funded Horizon2020 project carried out by seven different partners in six European countries (Norway, Finland, Sweden, Denmark, Belgium and the United Kingdom).

The overall objective of the RefugeesWellschool is to further the evidence-base on the role of preventive, school-based interventions in promoting refugee and migrant adolescents’ mental well-being, and on how they can be implemented in diverse educational settings.

Who can participate?
Refugee and migrant adolescents, their parents and teachers

What does the study involve?
To better understand the influence preventive programmes can have in school context the RefugeesWellSchool project will evaluate the effectiveness and implementation processes of following five preventive, school-based interventions:
1. In-Service Teacher Training and Teaching Recovery Techniques
2. Classroom Drama Therapy program
3. Welcome to school
4. PIER intervention
5. In-service Teacher Training

What are the possible benefits and risks of participating?
The specific potential benefits to adolescents participating in study depend on the intervention they are participating in. In general the RefugeesWellSchool project aims to reduce mental health problems, increased resilience, increased social support networks and positive inter-ethnic relationships and improve school belonging.

Where is the study run from?
Ghent University, Belgium

When is the study starting and how long is it expected to run for?
January 2019 to December 2020

Who is funding the study?
European Commission Directorate-general Research & Innovation

Who is the main contact?
Prof. Ilse Derluyn
ilse.derluyn@ugent.be

Trial website

https://refugeeswellschool.org/

Contact information

Type

Scientific

Primary contact

Prof Ilse Derluyn

ORCID ID

http://orcid.org/0000-0001-5450-1239

Contact details

Henri Dunantlaan 2
Ghent
9000
Belgium
+32 9 264 64 02
ilse.derluyn@ugent.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Preventive school-based interventions to promote the mental well-being of refugee and migrant adolescents

Acronym

Study hypothesis

RefugeesWellSchool will lead to the following six main outcomes :
1. Effective preventive, school-based interventions to increase refugee and migrant adolescents’ mental health and wellbeing
2. Culturally and contextually adapted assessment instruments
3. Increased social support and social cohesion; decreased mental health problems; increased executive functioning
4. Increased knowledge on the impact of preventive, school-based interventions and how to implement these interventions
5. Models to implement preventive, school-based interventions
6. Strong basis within EU to implement preventive, school-based interventions to promote the well-being of migrant and refugee adolescents.

Ethics approval

1. Approved 03/06/2019, Ghent University (Thierry Marchant, Ethical committee Faculty Psychology and Pedagogical Sciences, Henri Dunantlaan 2, 9000 Ghent, Belgium; no tel. provided; no email provided), ref: 2018/90/An Verelst
2. Approved 30/04/2019, KULeuven (Social and Societal ethics committee, KuLeuven, Dekenstraat 2, bus 3700, B-3000 Leuven, Belgium; no tel. provided; no email provided), ref: G- 2019 04 1626
3. Approved 08/01/2019, University of Sussex (Social Sciences & Arts C-REC, University of Sussex, Sussex House, Falmer, Brighton, BN1 9RH, United Kingdom; no tel. provided; c-recss@admin.susx.ac.uk), ref: ER/ES457/2
4. Approved 13/04/2018, University of Copenhagen (The Faculty of Health Sciences (SUND), Blegdamsvej 3B, 2200 København, Denmark; no tel. provided; no email provided), ref: 445827
5. Approved 28/08/2019, University of Uppsala (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; registrator@etikprovning.se; +46 (0)10-475 08 00), ref: 2019/895
6. Approved 03/04/2019, University of Tampere (Ihmistieteiden eettinen toimikunta/Heikki Eilo Päätalo C 141 33014 Tampereen yliopisto, Finland; no tel. provided; no email provided), ref: 21/2019

Study design

Interventional study design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental health

Intervention

Random allocation of the intervention types to the selected schools - Implementation of the interventions with about 1800 refugee and migrant adolescents in intervention conditions and 1000 in control conditions + 2500 non-newcomers in interventions in mixed classes in six countries and 1500 non-newcomers in control conditions

1. Classroom Drama Therapy Program (responsible expert: KULeuven, Belgium)
In a nine-week drama workshop intervention program, refugee and migrant adolescents in multi-ethnic schools work around the construction of group stories that support the construction of identity and meaning, aiming to establish bridges between past and present and to engage with themes of migration, exclusion, pluriform identities and cultural adaptation in host societies. The intervention is based on Boal’s forum and Fox’ playback theater, and was developed at McGill Transcultural Psychiatry and Concordia University Creative Arts.

2. Social Support Groups in Refugee Classes – Welcome to School (responsible expert: University of Copenhagen, Denmark)
This intervention builds on the Welcome to School initiative developed by the Pharos Refugees and Health Knowledge Centre (the Netherlands), with support from the European Refugee Fund. Rooted in the theoretical principles of social capital, the Welcome to School Initiative has demonstrated its potential to strengthen the competencies of refugee and migrant youth with regards to self-esteem, coping, social skills and behavioral adjustment. The initiative consists of 14 sessions that bring refugee and migrant adolescents of a class group together in small discussion groups under the guidance of a teacher, clustered into five units: (1) Introductions; (2) My country and the host country; (3) Me and the people around me; (4) Important things; and (5) Towards the future together.

3. Enhancing Peer Interactions and Social Capital – PIER (responsible expert: University of Sussex, UK)
The intervention ‘Enhancing Peer Interactions and Social Capital’ (PIER) develops a participatory approach to supporting safe, positive peer interactions and social relationships in multi-ethnic schools. Through clustering pupils with migrant and non-migrant background in small collaborative groups working together on establishing social connection and participatory activities in the school context, the intervention aims at strengthening school belonging and promoting dialogue between minority and majority groups.

4. In-Service Teacher Training (responsible expert: NKVTS, Norway)
The aim of the INSETT intervention is to enhance teachers’ insight into how refugee /migration experiences may impact young people’s psychosocial well-being and school functioning upon resettlement in a new country.
The intervention intends to strengthen teachers’ competence and self-efficacy in three areas: (1) Promoting refugee/migrant students’ mental health and psychosocial wellbeing; (2) Encouraging positive interethnic relationships and strengthening school belonging; and (3) Fostering supportive interrelationships with parents, caregivers and/or guardians to promote school involvement. In other words, INSETT seeks to make teachers and schools (more) ‘refugee competent’.
The INSETT intervention will run over a period of 10-12 weeks. It consists of three interrelated course modules, i.e., two collective learning modules (whole-day seminars) and – in between – an individual module (the Augeo online course).

5. INSETT + Teaching Recovery Techniques (TRT) (responsible expert: University of Tampere, Finland)
The intervention combining INSETT and TRT follows the recommendation of multi-layered or triaged approach to prevent mental health problems. It integrates both targeted therapeutic treatments for refugee/immigrant adolescents at risk (severe PTSD symptoms) and whole school psychosocial intervention to create This intervention combines psychosocial intervention in schools on different levels. An intervention is given both at teacher level as adolescent level. The INSETT + TRT intervention does not explicitly focus on refugee/migrant adolescents, but on the whole school classes as safe as a multicultural learning environment.

We will study the effectiveness of these five different interventions in relation to the mental well-being of the refugee and migrant adolescents taking part in these interventions. Hereto, we explicitly use a broad conceptualisation of ‘mental well-being’ looking at:
- Reduced mental health problems
- Increased resilience
- Increased social support networks and positive inter-ethnic relationships
- School belonging and school attendance

The five interventions are implemented in two to three countries to allow cross-country comparisons and in-country comparisons. Classroom Drama Therapy Intervention is implemented in Belgium, Denmark and the UK. Welcome To School is implemented in Denmark and Norway. PIER intervention is implemented in Finland and the UK. INSETT is being implemented in Norway and Sweden. INSETT+TRT is implemented in Finland and Sweden. In France and Spain revised and smaller-scale versions of the interventions are implemented.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Following self-report questionnaires (multi-lingual) will be completed by all participating adolescents prior to the intervention, immediately following the intervention, and three to five months post-intervention:
1.1 Socio-demographic characteristics
1.2 Prevalence of daily stressors (ongoing): Daily Stressors Questionnaire
1.3 Mental health symptoms: self-reported symptoms of emotional and behavioural problems through the strengths and difficulties (CRIES-8)
1.4 Resilience and social coping: Child and Youth Resilience Measure (CYRM) – Child version
1.5 Overall well-being: Self-designed question on overall well-being
1.6 Social support and experiences of exclusion and stigma: social support and quality of peer and friendship relations (Self-designed questionnaire); and experiences of exclusion and stigma (Brief Perceived Ethnic Discrimination Scale-Community Version (PEDQ-CV)
1.7 School Belonging: Psychological Sense of School Membership (PSSM)
1.8 Executive functioning: Amsterdam Executive Functioning Scale

2. Following questionnaires will be completed by the teachers:
2.1 Socio-demographic characteristics of the teachers: age, gender, nationality/migration status, languages, educational background, working experience
2.2 Mental well-being of participating adolescents: emotional problems and impact supplement: teacher version of the Strengths and Difficulties Questionnaire (SDQ-teacher), only used in Belgium
2.3 Cultural competence - Teacher Multicultural Attitude Scale (TMAS)
2.4 Teacher work stress - Single item stress index; Bergen burnout inventory
2.5 Teacher work engagement - Utrecht work engagement scale (UWES)
2.6 Teacher-home collaboration and trust – Trust scale
2.7 Classroom Atmosphere – 3 questions Together at school

3. Following questionnaires will be completed by parents of a selection of the participating adolescents:
3.1 Questionnaire on socio-demographic characteristics: age of parent and adolescent, gender of parent and adolescent, socio-economic status (educational level, current job situation), familial composition, migration status, time in the host country, current living context
3.2 Mental well-being of a selection of the participating adolescents: emotional problems and impact supplement: parent version of the Strengths and Difficulties Questionnaire (SDQ-parent) in a limited number of partner countries namely Belgium and Denmark
3.3 Parental scholastic Involvement: Parents’ Scholastic Support Practices
3.4 Parental general health: Short Form Health Survey, SF-36
3.5 Parental mental health: GHQ-12 (General health questionnaire-12)
3.6 Parenting: Parent Sense of Competence (PSOC-16)
3.7 Teacher-parent collaboration and trust: Trust scale
3.8 Discrimination: Brief Perceived Ethnic Discrimination Questionnaire – Community version (PEDQ-CV) (Brondolo et al., 2005).

4. Executive Functioning (having a strong relationship with increased academic skills) will be assessed: If possible considering the national ethical guidelines and National Stakeholders Committee recommendations and agreed upon by the participants, we will ask for school attendance rate during the implementation and follow-up assessment phases of the project (up to two to five months after the intervention has finished).

5. Focus groups with adolescents, teachers and parents: all participating adolescents, teachers and parents will be asked to take part in separate focus group discussions (at least one focus group per participant group per intervention: (a mean of) 18 groups x 6 countries = 108 focus groups), on how they look at the effectiveness of the intervention in relation to the different outcome variables, with a particular focus on the increase in social support and the decrease of stigma, exclusion and marginalisation.

The assessment measures are generally the same over all countries (except for France and Portugal where a reduced assessment protocol is implemented). However, in some countries, the focus will be more on qualitative measures for teachers and parents than quantitative measures with these particular groups.
Depending on the educational context (e.g. the existence of targeted classes for newcomers compared to mixed classes) data will be collected with both newcomers and non-newcomers (potentially also with a migrant background.

Secondary outcome measures

1. Overall evaluation of the interventions (evaluation of the implementation processes): focus groups discussions with adolescents, teachers and parents: all participating adolescents, teachers and parents will be asked to take part in separate focus group discussions (at least one focus group per participant group per intervention: (a mean of) 18 groups x 6 countries = 108 focus groups)
2. Evaluating contextual factors impacting the implementation (process evaluation): focus group with different stakeholders and experts (e.g., policymakers in the field of education, health and migration, school board members, advocacy networks, academic experts,...) will be conducted, completed with the members of the National Stakeholders Committee. Some RefugeesWellSchool partners have introduced additional qualitative studies to the design to strengthen the evaluation of the implementation process as well as to shed light on the contextual factors that might influence the impact of interventions. In the UK an elaborated ethnographic study will be carried out in one school to better understand how the interventions are implemented and evaluated. A similar qualitative design is carried out in Denmark with regards to the implementation of the Welcome To School programme. In Belgium, qualitative research of cases will help illuminate on the intervention process and the perceptions of parents and their respective children
3. Assessing the economic impact of the intervention: we will seek to capture all societal costs and benefits as fully as possible. Costs to deliver the interventions will be estimated based on trial data. Other societal costs will be derived from information on the use of healthcare and other resources. In a cost-utility analysis, conducted alongside the trial, benefits measured combine mortality and morbidity into Quality Adjusted Life Years (QALYs)

Overall trial start date

11/04/2017

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Refugee and migrant adolescents, their parents and teachers

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

adolescents (5000) + teachers (140) + parents (600)

Participant exclusion criteria

1. Minors under the age of 13
2. Those considered too vulnerable to participate

Recruitment start date

01/01/2019

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Belgium, Denmark, France, Norway, Portugal, Sweden, United Kingdom

Trial participating centre

Ghent University
Ghent
9000
Belgium

Trial participating centre

KULeuven
Leuven
3000
Belgium

Trial participating centre

University of Sussex
Brighton
BN1 9RH
Belgium

Trial participating centre

University of Copenhagen
Copenhagen
1000
Belgium

Trial participating centre

Nasjonalt kunnskapssenter om vold og traumatisk stress
Oslo
0484
Belgium

Trial participating centre

Uppsala Universitet
Uppsala
752 36
Belgium

Trial participating centre

University of Tampere
Tampere
33101
Belgium

Trial participating centre

University of Toulouse
Université Fédérale Toulouse Midi-Pyrénées - siège social 41 Allées Jules Guesde - CS 61321
Toulouse
31013
Belgium

Trial participating centre

University of Lisbon
Cidade Universitária, Alameda da Universidade
Lisbon
1649-004
Belgium

Sponsor information

Organisation

Ghent University

Sponsor details

St. Pietersnieuwstraat 33
Ghent
9000
Belgium
+32 (0)9 331 01 01
info@ugent.be

Sponsor type

University/education

Website

https://www.ugent.be/nl

Funders

Funder type

Government

Funder name

European Commission Directorate-general Research & Innovation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1.Publications on the study findings (target groups: practitioners, teachers, academics, and policy makers)
2.Distribution of protocols via newsletter, website (open access); distribution of hard copies; distribution via own networks
3.Distribution of reports with the study findings via newsletter, website (open access) and own networks of project partners
4.Meetings with the European Project Stakeholders Committee
5.‘Implementation Workshops’ to discuss the project results
6.Presentations at conferences, seminars, trainings
7.Availability to give trainings to practitioners

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to decisions by the Project consortium as guided by the Ethical advisor, Ethical committee, National Committees and European Stakeholders Committee. Given the ethical concerns of sharing sensitive personal information of participants in this study, that might constitute potential harm as described in Recital 75 of the European GDPR, the datasets itself will not be shared publicly. Publications on the findings of the RefugeesWellSchool project will be published in Open Access platforms.

Intention to publish date

01/01/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/12/2019: Trial’s existence confirmed by University of Sussex