Condition category
Mental and Behavioural Disorders
Date applied
18/12/2019
Date assigned
20/12/2019
Last edited
10/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
In recent years, a large number of refugees have sought asylum in Europe, and more than half of refugees arriving in Europe are children or adolescents. These youths have often experienced trauma during relocation and continue to face adversity in their host country in the form of acculturation stress, residence insecurity, social isolation, and experiences of discrimination. These experiences are associated with a significant risk of developing mental health problems such as post-traumatic stress disorder. This study aims to evaluate the effectiveness of a school-based intervention that provides a manualized, trauma-focussed programme called Teaching Recovery Techniques (TRT) to target refugee and migrant youth and an In-Service Teacher Training programme to teachers. The study will consider the impact of the intervention on the mental health of adolescent refugees and their guardians who participate in the TRT programme. It will also consider the intervention’s impact on the interrelationships between teachers and parents and teachers’ cultural competence, as well as the social support and school belonging experienced by adolescents who do not participate in TRT but whose teachers receive INSETT training.

Who can participate?
The TRT portion of the intervention will be offered to consenting refugee youths who score high on a post-traumatic stress survey, have spent six years or less in Sweden, and who are attending a target secondary or upper secondary school. Their parents/guardians may also participate if they consent to do so. The INSETT portion of the intervention will be offered to consenting teachers who are attending a target secondary or upper secondary school. Finally, consenting adolescents who do not meet the inclusion criteria to receive TRT but are attending a target school where teachers are receiving INSETT may still participate in data collection for the study.

What does the study involve?
The study involves delivering an intervention to adolescents, their parents/guardians, and teachers in their schools, either in the current school year or the following school year. Adolescents who meet screening requirements and their guardians will be offered the TRT programme, and those who accept will participate over seven weeks. Adolescents who do not have guardians can still participate on their own. Furthermore, adolescents who do not meet the inclusion criteria for the TRT portion of the intervention can still participate in the study’s data collection. Teachers will be offered the INSETT programme and those who accept will participate over 10 - 12 weeks. Data will be collected using surveys prior to the intervention, immediately following the intervention, and three months post-intervention. Information will be gathered on the mental health of youth and parents participating in TRT, the cultural competence and parent-teacher interrelationships of teachers’ participating in INSETT, and on the social support and school belonging experienced by youth who do not participate in TRT but whose teachers participate in INSETT.

What are the possible benefits and risks of participating?
The potential benefit to youth participating in TRT and their parents/guardians is a better understanding of how to care for themselves, leading to improved mental health and wellbeing. The potential benefit to participating teachers is an increase in self-efficacy and cultural competence. Given the focus of the interventions on improving social support networks, we also expect schools environments may increase in social support and cohesion which would benefit all youth and their teachers. Answering personal questions can make some participants uncomfortable. All participation is voluntary and can be stopped at any time. A safety protocol to prevent self-harm among youth participants has been developed. The guidelines include clear instructions on who to call and what to do based on when the danger is identified. In all cases, participants who are at-risk are connected to local psychiatric services. The safety protocol is revised for each site and signed by local senior managers. Youth who are receiving mental health treatment are also requested to consult with their healthcare provider before choosing whether to participate.

Where is the study run from?
The Child Health and Parenting (CHAP) research group at Uppsala University (Sweden)

When is the study starting and how long is it expected to run for?
January 2018 to March 2022

Who is funding the study?
European Union Horizon 2020

Who is the main contact?
Prof. Anna Sarkadi
anna.sarkadi@pubcare.uu.se

Trial website

https://www.pubcare.uu.se/research/chap/projects/ongoing-projects/refugeeswellschool/ and https://refugeeswellschool.org/sv/

Contact information

Type

Scientific

Primary contact

Prof Anna Sarkadi

ORCID ID

http://orcid.org/0000-0001-6594-2291

Contact details

BMC
Husargatan 3
Uppsala
751 22
Sweden
+46 (0)18 471 6572
anna.sarkadi@pubcare.uu.se

Type

Scientific

Additional contact

Dr Fatumo Osman

ORCID ID

http://orcid.org/0000-0002-0038-9402

Contact details

BMC
Husargatan 3
Uppsala
751 22
Sweden
+46 (0)701918604
Fatumo.Osman@pubcare.uu.se

Type

Scientific

Additional contact

Dr Natalie Durbeej

ORCID ID

http://orcid.org/0000-0001-9916-0087

Contact details

BMC
Husargatan 3
Uppsala
751 22
Sweden
+46 (0)737041948
Natalie.Durbeej@pubcare.uu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Grant agreement No 754849

Study information

Scientific title

Effectiveness of a school-based intervention for adolescents and teachers to promote mental health among refugee and migrant adolescents

Acronym

RWS-SE

Study hypothesis

This study involves an intervention with two components: the Teaching Recovery Techniques (TRT) which is delivered to target students and may include their guardians, and the In-Service Teacher Training (INSETT) which is delivered to teachers. We will collect outcome data from multiple groups who we hypothesize will be impacted by this intervention: adolescents who receive TRT, the parents of adolescents receiving TRT who participate in TRT as guardians, teachers who receive INSETT, and adolescents who do not receive TRT but whose teachers received INSETT. These groups of participants in the intervention arm of the study will be compared to participants from the same group who are in the waitlist-control arm of the study and did not receive the intervention. We have identified the following hypotheses for these groups:

Adolescents who receive TRT:
When compared with adolescents in the waitlist-control arm who meet the inclusion criteria for TRT participation but who have not received the intervention, adolescents who received TRT are hypothesized to report fewer post-traumatic stress disorder (PTSD) symptoms.

Parents who attend TRT as guardians:
When compared with parents in the wait-list control arm whose children meet the inclusion criteria for TRT participation but who have not received the intervention, parents who participate in TRT as guardians are hypothesized to report fewer mental health problems.

Teachers who receive INSETT:
When compared with teachers in the wait-list control arm who did not receive INSETT, teachers who received INSETT are hypothesized to report higher levels of social support and school belonging, and will report a greater degree of multicultural knowledge.

Adolescents who do not receive TRT:
When compared to adolescents in the waitlist-control arm who do not participate in TRT and whose teachers did not receive INSETT, adolescents who did not participate in TRT but whose teachers did participate in INSETT are hypothesized to report higher levels of social support and school belonging.

Ethics approval

Approved 24/07/2019, Regional Ethics Review Board in Uppsala (Etikprövningsmyndigheten Box 2110, 750 02, Uppsala, Sweden; Tel: +46 (0)10-4750800; Email: registrator@etikprovning.se), ref: 2019-03160

Study design

Two-arm randomised waitlist control superiority trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Condition

Symptoms of post-traumatic stress

Intervention

The trial has two arms (i.e., an intervention arm and a control arm) and the cluster is assigned by school and in an allocation ratio of 1:1. The researchers used an online randomisation tool named sealed envelope (https://www.sealedenvelope.com/)

Youth in the intervention arm will participate in data collection and will be screened to determine whether they receive the Swedish translation of the Teaching Recovery Techniques (TRT) programme. Youth in the intervention arm will be offered TRT if they meet the following TRT inclusion criteria:
1. CRIES-8 score ≥ 17
2. Time spent in Sweden ≤ 6 years
3. Therapist does not advise against intervention

The TRT programme is a group-based cognitive-behavioural programme that includes 2 parent/guardian sessions and 7 youth sessions. It is delivered to qualifying youth in the intervention schools and may also be delivered to their parent/guardian, though adolescents do not need to have a participating guardian to take part in TRT. Parent/guardian sessions focus on psychoeducation. One session is delivered prior to the commencement of the youth sessions and the other is delivered between the second and fourth youth session. Youth sessions focus on psychoeducation, intrusion, arousal, avoidance, and coping strategies. The first session is a ‘getting to know each other session’ and the final session is a ‘follow-up session’ which consolidates learning and enables participants to talk about their experience of taking part in the programme. Sessions will be delivered over 7 consecutive weeks and each session will last 2 hours (including a break). TRT facilitators will receive 3 days of training in programme delivery. Adolescents who receive TRT and their parent/guardian, if one participates, will be invited to take part in data collection.

Teachers in the intervention arm will receive In-Service Teacher Training (INSETT). This intervention will run over a period of 10-12 weeks and will consist of 3 interrelated course modules. One module is an online course completed by the individual. The course features 8 sections (4-5 hours of study in total) focusing on relevant themes like trauma and stress, the therapeutic window of tolerance, self-regulation and coping, and identify and belonging. Each section provides theory, case histories, exercises, and recommendations for further reading. The remaining 2 modules consist of whole-day seminars delivered in a group setting. One seminar takes place before the online course and provides an introduction to the course along with fundamental terms and information about the refugee experience. The other seminar takes place after the online course is completed and allows participants to consolidate learning and share their experiences.

Teachers who receive INSETT will be invited to participate in data collection. Furthermore, adolescents who do not meet the inclusion criteria for TRT but whose teachers have participated in INSETT (i.e., all non-TRT-receiving adolescents in the intervention arm) will also be invited to participate in data collection.

The waitlist-control arm will receive services as usual. Following the implementation of the interventions in the intervention arm cluster, the waitlist-control cluster will be offered the interventions after follow-up data has been collected.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The following outcomes are measured at baseline, post-intervention, and at three months follow-up:

Adolescents who receive TRT:
Measures of mental health problems including:
PTSD symptoms, measured using the Children’s Revised Impact of Event Scale (CRIES-8)

Parents who attend TRT as guardians:
Measures of mental health problems including:
Mental health, measured by the General Health Questionnaire (GHQ12)

Teachers who receive INSETT:
1. Measure of supportive parent-teacher interrelationships, including:
Teacher-parent collaboration, measured by the Trust Scale (TS)
2. Measure of cultural competence, including:
Multicultural awareness and understanding, measured by the Teacher Multicultural Attitude Scale (TMAS)

Adolescents who do not receive TRT:
Measures of social support and school belonging including:
Feelings of belonging at school, measured by the Psychological Sense of School Membership Scale

Secondary outcome measures

The following outcomes are measured at baseline (except the adolescent PHQ-9 and teacher classroom atmosphere measure), post-intervention, and at three months follow-up:

Adolescents who receive TRT:
1. Other measures of mental health problems and wellbeing including:
1.1. Internalizing and externalizing problems, measured using the Strengths and Difficulties Questionnaire (SDQ)
1.2. Depression severity, measured using the Patient Health Questionnaire-9 (PHQ-9)
1.3. Experience of the amount of stressors in daily life, measured by the Daily Stressors questionnaire (DSSYR)
1.4. Positive development and resilience, measured by the Child and Youth Resilience measure (CYR-12)
1.5. Wellbeing, measured by one item developed for this study
2. Measures of social support and school belonging including:
2.1. Social support, measured by a Multidimensional Scale of Perceived Social Support
2.2. Existence of interethnic friendships and friendship satisfaction, measured by questions developed for this study
2.3. Experience of discrimination, measured by The Perceived Ethnic Discrimination Questionnaire
2.4. Feelings of belonging at school, measured by the Psychological Sense of School Membership Scale
3. Measure of cognitive functioning, including:
Perception of one’s own executive functions, measured by the Amsterdam Executive Function Inventory (AEFI)

Parents who attend TRT as guardians:
1. Other measures of mental health problems including:
1.1. Self-reported health, measured by one item on the SF-36
1.2. PTSD symptoms in the parent, measured by the PTSD-8 questionnaire
2. Measures of social support and school belonging including:
2.1. Teacher-parent collaboration, measured by the Trust Scale (TS)
2.2. Experience of discrimination, measured by The Perceived Ethnic Discrimination Questionnaire
2.3. Social support, measured by the Social Support Instrument (ESSI)

Teachers who receive INSETT:
1. Measures of teachers’ self-efficacy and experiences with work, including:
1.1. Stress symptoms, measured by the Single Item Stress Index (SISI)
1.2. Work exhaustion/burnout, as measured by the Bergen Burnout Inventory (BBI)
1.3. Work engagement including vigor, dedication, and absorption, measured by the Utrecht Work Engagement Scale (UWES)
1.4. Self-Efficacy, measured by the Teachers’ Sense of Efficacy Scale (TSES)
2. Measure of school climate, including:
2.1. Classroom atmosphere, measured using a scale developed in a psychosocial school intervention study

Adolescents who do not receive TRT:
1. Other measures of social support and school belonging including:
1.1. Social support, measured by a Multidimensional Scale of Perceived Social Support
1.2. Existence of interethnic friendships and friendship satisfaction, measured by questions developed for this study
1.3. Experience of discrimination, measured by The Perceived Ethnic Discrimination Questionnaire

Overall trial start date

01/01/2018

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria for schools:
1. Must be multi-ethnic secondary schools that have grades 7–8 and/or introduction classes for newcomer adolescents, including at upper secondary schools
2. Must have an interest in participating in the school-based interventions.

Inclusion criteria for adolescents who receive TRT:
1. Legal guardian consents to participation if the adolescent is <15 years
2. Adolescent self-consents to participate if they are ≧15 years
3. Time spent in Sweden less than or equal to 6 years
4. Screen positive on the Children’s Revised Impact of Event Scale-8 (CRIES- 8) PTSD screening tool (≥17 points)
5. Therapist does not advises against intervention

Inclusion criteria for parents/guardians:
1. Parent/guardian consents to participation
2. Parent/guardian has a child who receives TRT

Inclusion criteria for teachers:
1. Teacher consents to participation

Inclusion criteria for adolescents not receiving TRT:
1. Legal guardian consents to participation if the adolescent is <15 years
2. Adolescent self-consents to participate if they are ≧15 years

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Ten control clusters and twenty intervention clusters with 25 participants in each cluster, resulting in 750 individuals total.

Participant exclusion criteria

Exclusion criteria for schools:
1. School is not multiethnic (i.e., fewer than 30% of students have a non-Swedish background)
2. School is not interested in participating

Exclusion criteria for adolescents who receive TRT:
1. Legal guardian does not consent to participation if the adolescent is <15 years or adolescent does not self-consents to participate if they are ≧15 years
2. Time spent in Sweden is greater than 6 years
3. Screen negative on the Children’s Revised Impact of Event Scale-8 (CRIES- 8) PTSD screening tool (less than 17 points)
4. Therapist advises against intervention

Exclusion criteria for parents/guardians:
1. Parent/guardian does not consent to participation
2. Parent/guardian does not have a child who receives TRT

Exclusion criteria for teachers:
1. Teacher does not consent to participation

Exclusion criteria for adolescents not receiving TRT:
1. Legal guardian does not consent to participation if the adolescent is <15 years or adolescent does not self-consent to participate if they are ≧15 years

Recruitment start date

13/08/2018

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Child Health and Parenting (CHAP)
BMC, Husargatan 3
Uppsala
751 22
Sweden

Sponsor information

Organisation

Uppsala University

Sponsor details

Box 256
Uppsala
75105
Sweden
+46 (0)18 471 00 00
contact@uu.se

Sponsor type

University/education

Website

http://www.uu.se

Funders

Funder type

Government

Funder name

Horizon 2020

Alternative name(s)

European Union Framework Programme for Research and Innovation, EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

Trial protocol and results to be published.

IPD sharing statement
Per the ethics approvals, no individual-level data may be made available. However, aggregated results are/will be available upon request from Prof. Anna Sarkadi (anna.sarkadi@pubcare.uu.se).

Intention to publish date

31/03/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/06/2020: The recruitment end date 19/05/2020: Due to current public health guidance, recruitment for this study has been paused. 19/12/2019: Trial's existence confirmed by Regional Ethics Review Board in Uppsala.