Condition category
Mental and Behavioural Disorders
Date applied
08/05/2017
Date assigned
13/06/2017
Last edited
13/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The transition from childhood into adolescence is a time of development, which involves physical, mental, emotional challenges. These developments often coincide with issues such as stronger reactions and vulnerability to developing mental health problems. Studies have shown that at least 15-20% of adolescents suffer from mental health issues. Boost Camp is a new universal prevention program which aims to stimulate the use of emotion regulation strategies, improve adolescent mental health, lower risk for developing mental health problems during the stressful life period of school transition, and increasing mental health knowledge while decreasing stigmatization (negative associations). The aim of this study is to find out whether delivering this program to adolescents can help improve their mental health and emotion regulation.

Who can participate?
Adolescents in their first year of secondary school.

What does the study involve?
Participating schools are randomly allocated to one of two groups. Those in the first group continue as normal for the duration of the study. Those in the second group take part in the Boost Camp program. This involves learning and practicing emotional awareness, acceptance, relaxation, distraction, cognitive reappraisal and problem solving through exercises, both as individuals and in groups. Participants fill out questionnaires about mental health and emotion regulation four times through the first year of high school. This happens during school time and under the supervision of the classroom teacher and someone of the department.

What are the possible benefits and risks of participating?
Participating in the study can be beneficial for the participating schools, because they can receive an overall report of the results about the mental health status of their students. The classes who participate gain a class photo-shoot as a reward for their commitment. There are no significant risks involved with participating. Although participation requires time and investment from management board, teachers and their students.

Where is the study run from?
Six schools located in Flanders (Belgium)

When is the study starting and how long is it expected to run for?
April 2016 to May 2018

Who is funding the study?
Research Foundation Flanders (Belgium)

Who is the main contact?
1. Miss Brenda Volkaert (public)
2. Miss Laura White (scientific)

Trial website

Contact information

Type

Public

Primary contact

Miss Brenda Volkaert

ORCID ID

http://orcid.org/0000-0002-9550-8653

Contact details

Ghent University
Henri Dunantlaan 2
Ghent
9000
Belgium

Type

Scientific

Additional contact

Miss Laura Wante

ORCID ID

Contact details

Ghent University
Henri Dunantlaan 2
Gent
9000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0E9217N

Study information

Scientific title

Evaluating efficacy of a school-based transdiagnostic adolescent mental health prevention program, targeting emotion regulation: A randomised controlled trial

Acronym

Study hypothesis

Compared to adolescents in the control group, adolescents in the Boost Camp group will show better mental health and more adaptive emotion regulation.

Ethics approval

Not provided at time of registration

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

Emotion Regulation (ER)

Intervention

When schools agree to participate, they are randomly assigned to the controle or the intervention condition. In this way, randomisation is clustered since the participating classes of one and the same school are always in the same condition.

Intervention group: Students from schools in the intervention group receive an school-based adolescent training, named 'Boostcamp'. This is a group training for adolescents who are making the transition from primary to secondary school and focuses on improving ER and social skills. The program consists of three different parts:
1. An information moment in which the program is explained and written informed consent will be collected
2. A two-day ‘immersion’ training program
3. Two booster sessions over the subsequent three months of the first semester.
The training is organized at the beginning of secondary school. During two full days, youngsters learn about adaptive ER strategies, social skills, and how to use them in challenging emotional and social situations. The trainers or employees or students of our department, with at least a bachelor's degree in psychology and are coached and guided by the two main investigators who are also trained clinical psychologists.

Control group: Students from schools in the control condition are asked to fill out all the self report questionnaires just like students in the experimental condition and on the same time. However, the control condition do not participate in the two-way training program or the boostersessions.

There are two follow-up measurements: one at the end of the first semester (December 2017) and one at the end of the second semester (May 2018). Both assessments include the same questionnaires as at the baseline.
The students in the experimental condition receive two ‘boostersessions’, in which they repeat the learned theory and skills of the Boostcamp and get opportunities to practice with lifelong situations under the supervision of trainer. These Boostersessions take place before and between the two follow-up moments (at the end of December and at the end of March).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Adolescent mental health is assessed using the Youth Self Report (YSR), Positive and Negative Affect Schedule for Children (PANAS-C), Children’s Depression Inventory (CDI), Compententie Belevingsschaal voor Adolescenten (CBSA), and KIDSCREEN-10 HRQoL for Children and Adolescents (KIDSCREEN-10) at baseline, 8 weeks and 6 months
2. Emotion regulation is assessed using the FEEL-KJ questionnaire, the emotion regulation skills questionnaire (ERSQ) and he subscale 'Emotional Awareness' of the Difficulties in Emotion Regulation Scale (DERS) at baseline, 8 weeks and 6 months. The positive and negative affect (PANAS-C), depression (CDI), emotion regulation skills (ERSQ) and Global Self Worth (CBSA) are assessed immediatly after the two days training (in the last hour of the training).

Secondary outcome measures

1. Mental health knowledge and stigma is measured using qualitative questions at baseline, 8 weeks and 6 months
2. School absenteeism and academic achievement are measured by the school through the whole school year as usual and will be delivered to the investigator after the last questionnaires

Overall trial start date

25/04/2016

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 10 - 14 years
2. In the first year of secondary school
3. In a participating class

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

Six schools (3 control, 3 intervention), 14 classes (7 control, 7 intervention), 280 students (140 control, 140 intervention)

Participant exclusion criteria

Not meeting inclusion criteria.

Recruitment start date

01/02/2017

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Belgium

Trial participating centre

Leiepoort campus Sint-Hendrik
Guido Gezellelaan 105
Deinze
9800
Belgium

Trial participating centre

VTI
Leon Declercqstraat 1
Deinze
9800
Belgium

Trial participating centre

Koninklijk Atheneum Erasmus Deinze
Volhardingslaan 11
Deinze
9800
Belgium

Trial participating centre

Ten Doorn
Zuidmoerstraat 125
Eeklo
9900
Belgium

Trial participating centre

Mariagaard
9230, Oosterzelesteenweg 80
Wetteren
9230
Belgium

Sponsor information

Organisation

Ghent University

Sponsor details

Henri Dunantlaan 2
Ghent
9000
Belgium

Sponsor type

University/education

Website

ugent.be

Funders

Funder type

Government

Funder name

Fonds Wetenschappelijk Onderzoek

Alternative name(s)

Research Foundation Flanders, Flemish Research Foundation, FWO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Belgium

Results and Publications

Publication and dissemination plan

The intention is to submit a protocol paper of the study before the first assessment take place (September 2017) and an article get published after one year of the overall trial and date in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/05/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes