One of the primary goals is to establish whether students in the first grade of secondary vocational education receiving the multimodal school-based stepped approach towards preventing suicidal behaviours and depression show a clinically significant…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Severity of suicidality
Secondary outcome
Self-esteem
Self-efficacy
Quality adjusted life year (QALY) health gains
Student motivation and classroom satisfaction
School related factors (academic grades, drop-outs, truancy and non-attendance)
Demographic characteristics
Background summary
In the Netherlands since 2010 a national increase in the amount of suicides has
been observed (CBS, 2016). Nowadays, suicide is the most important cause of
death in the age category 10 to 25 years (CBS, 2016). It has been shown that
among the adolescents that successfully committed suicide 60-90% was suffering
a depressive disorder (Orbach et al., 2009), indicating an association between
suicide and depression. Within the age range of 15-21 years old the amount of
clinical depressions increases steeply with higher age (Hankin, 2002). Yearly,
4% of the adolescents suffers from a depressive disorder (Meijer et al., 2006).
20% of the adolescents until the age of 20 experienced depressive thoughts
(Bertha & Balazs, 2013). Depressive thoughts are a risk factor for the
development of a depression (Johnson et al., 2009). Furthermore, depressive
thoughts can on themselves lead to dysfunction (Balazs et al., 2013). This
shows that depression and suicide among adolescents are important problems to
tackle. Currently no interventions are deployed in the Netherlands that are
well organized intervention and/or have been proven effective to prevent
depression and suicide (RIVM, 2014). This indicates that preventive strategies
concerning suicide and depression in adolescents are necessary.
Study objective
One of the primary goals is to establish whether students in the first grade of
secondary vocational education receiving the multimodal school-based stepped
approach towards preventing suicidal behaviours and depression show a
clinically significant reduction of suicidal behaviours and depressive symptom
severity levels when compared to the students receiving care as usual.
Study design
In order to achieve the primary and secondary aims of this research a clustered
randomized controlled trial (RCT) will be conducted in two parallel groups
comparing an experimental condition with a control condition. Randomization
will be conducted at the level of school location to avoid contamination. Both
the control and experimental conditions receive two interventions: (1) a
gatekeeper training for the mentors of the students in the first grade of
secondary vocational education for early recognition of suicidality and
referral where required, and (21) screening for depression and suicidality
(with prompt referral to professional health care when indicated). These two
interventions will ensure the safety of suicidal students in both trial
conditions. It should also be noted that all students will have unrestricted
access to care as usual as offered by the general practitioners and mental
health care services that are available in the Netherlands. This means that the
control condition consists of care as usual plus the two interventions that act
as a safety net. The control condition will therefore be described as enhanced
usual care. The experimental condition receives two additional interventions:
(3) a universal preventive intervention directed at raising awareness about
depression and reducing (self-) stigma with regard to depressive symptoms, and
(4) an indicated preventive intervention offered to those with elevated levels
of depressive symptoms. The multimodal integrated stepped nature of the program
requires integral testing of the interventions rather than testing the effects
of the single components of the prevention program. Outcomes will be assessed
primarily through adolescent self-reports at baseline, mid-intervention,
post-intervention, and at 6, 12 and 18 months after program ending.
Intervention
The multimodal prevention program consists of four modules. Both the
experimental and the control condition will receive 2 modules, including the
gatekeeper training for mentors of the students in the first grade of secondary
vocational education and a screening for the students. These modules will
ensure the safety of possibly suicidal students. The experimental condition
will, in addition to the gatekeeper training and screening, receive two extra
interventions, including universal prevention (*Moving Stories*) and indicated
prevention (*Op Volle Kracht MBO*). Details concerning the interventions are
described below.
Gatekeeper training
All mentors of the students in the first grade of secondary vocational
education will receive a gatekeeper training. In this training the mentors will
learn to (1) recognise suicidality, (2) make contact with the student and to
frankly discuss suicidality, and (3) refer the students with high severity of
suicidality to professional health care (either the student*s GP or specialised
mental health care).
Screening
All students in the first grade of secondary vocational education will be
screened for suicidality by filling in the 10-item VOZZ-Screen (Kerkhof et al.,
2015) and the CDI-2 (Kovacs, 2011). The screening will be conducted by the
community health services (in Dutch: GGD). The screening doubles as the
baseline assessment of the study. Based on the VOZZ-Screen score and item 8 of
the CDI-2 (suicide question) we will determine the individual students in the
high suicide risk group. Screen-positive students (10-item VOZZ-Screen > 23 or
CDI-2 item 8 >1) will be seen within 48 hours by GGD staff for a 1-hour
semi-structured interview. The interview includes assessment of suicide risk
through open but systematic discussion of issues that are relevant to the
individual student. Immediately following these interviews and when the
screen-positive result is confirmed in the suicide risk assessment, the parents
or guardians will be contacted and informed about the findings and concerns
regarding the safety of that student. At this time a safety plan will be agreed
upon, including (potential) referral to primary care (general practitioner) or
the specialized mental health services (GGZ Oost Brabant).
Universal prevention (*Moving Stories*)
All students in the first grade of secondary vocational education whose school
location is randomized in the experimental condition will first receive the
universal prevention *Moving Stories*, consisting of depression awareness
training, targeting (self-) stigma related to depression and aiming to induce
better help-seeking behaviours when confronted with depression. *Moving
Stories* starts with an introductory session taking place during a mentoring
class, which includes an explanation of how to download and play the serious
game. Furthermore, it will be explained that everybody plays the serious game 5
consecutive mornings and that, during the afternoon, feedback will be provided
about the students* performed actions in the game that morning. After the
serious game has been played for 5 consecutive mornings another mentor lesson
will be used to offer insight in what (living with) depression entails via a
discussion with an experiential expert. Furthermore, students* experiences with
*Moving Stories* will be discussed and the question *how to act when you
yourself experience depressive symptoms and/or recognize these symptoms in
peers* will be answered in an interactive fashion. The discussion will be led
by a well-trained and supervised psychiatric nurse (from GGZ Oost Brabant).
Indicated prevention (*Op Volle Kracht MBO*)
All students in the first grade of secondary vocational education randomized in
the experimental condition and showing elevated severity of depressive symptoms
(CDI-2 > 14) upon screening will be asked to participate in the indicated
prevention *Op Volle Kracht MBO* (OVK MBO). OVK MBO is modified from of the
original *Op Volle Kracht* program, which is based on the principles of
cognitive behavioral therapy (CBT). OVK MBO also includes an e-mental health
mobile application called *Boost My Mood* which entails a stepped depression
prevention approach consisting of evidence-based CBT modules, exercises and
techniques. Via the e-mental-health mobile application (*Boost My Mood*)
students* will be able to enhance their knowledge concerning CBT techniques, to
practice CBT techniques and to monitor their depressive symptoms (part of CBT).
All students that provided active informed consent will follow 6 face-to-face
group sessions, each of 45 minutes and provided twice a week or weekly. These
face-to-face CBT sessions will be delivered by professionals that received an
extensive 3-day training program in the necessary skills such as CBT and its
theoretical background, a training manual, and the intervention protocol. Via
the e-mental-health mobile application (*Boost My Mood*) students will be able
to enhance their knowledge concerning CBT techniques, to practice CBT
techniques and to monitor their depressive symptoms in their own time whenever
suits them.
Study burden and risks
Risk
Previous research concerning the various aspects of our study has shown no risk
for participants * rather on the contrary. Suicidal participants feel less
distressed after completing a survey about suicidal behaviours (screening)
(Gould et al., 2005). According to an extensive review of the research
literature, no adverse effects have been observed in participants concerning
suicidality in any research * meaning that suicidal thoughts and behaviours did
not increase when people engage in research (Kerkhof & Huisman, 2017). It is
even recommended by Kerkhof & Huisman (2017) to include a screening, followed
by referral, and gatekeeper trainings in the research design of a study,
because it is appreciated by the study*s participants and lowers risk of
suicide. A similar universal prevention program to the one in this study did
not show any adverse effect among students (Asiltine et al., 2007). In another
youth awareness program (Wasserman*s et al. school-based suicide prevention
(SEYLE) study among more than 11,000 students, which was published in The
Lancet in 2015) indicated that severe suicidal ideation was reduced to a half
(OR=0.45) in the recipients of this program. Lastly, for the intervention on
which the indicated intervention in this study is based, no adverse effects
have been described (Wijnhoven et al., 2013). Moreover, every component of this
study is in compliance with the recommended guidelines on how to communicate
about suicide in order to minimalize the effect of imitation (Wasserman &
Narboni, 2001; De Jaegere, & Portzky) and to ensure the safety of our
participants (Kerkhof & Huisman, 2017). Therefore, we are of opinion that the
risks associated with participation can be considered negligible and that
participating in our study and the interventions embedded therein is mitigating
the risk of suicide rather than increasing this risk.
Burden
Suicidality and depressive symptoms during adolescence are a prominent
individual and societal problem. In order to determine whether the prevention
program is effective in reducing severity of suicidal behaviours among
adolescents in the first grade of secondary vocational education, it is
necessary that these adolescents participate in the interventions and fill in
the questionnaires in order to monitor the effect of the interventions. Within
the prevention program it is expected that (self-)stigma concerning depressive
symptoms will be reduced via the universal prevention, and that in addition
help-seeking and health-promoting behaviours will be encouraged. Furthermore,
adolescents with high severity levels of suicidality will be referred to
professional health care. We believe that due to the societal impact and the
gain of students with depressive and suicidal thoughts (reduction of these
thoughts due to the interventions and referral) justifies the burden
(participating in screening, filling in 6 questionnaires and participating in 2
interventions) of the subjects. Lastly, receiving interventions and filling in
questionnaires will happen at the location of the school of the student and
mostly during mentoring lessons (of the regular school curriculum) to ensure
that the time investment after school hours is kept to an absolute minimum and
would essentially consist of engaging in both e-health interventions (Moving
Stories and Boost My Mood), both of which have been designed specifically for
this target group with avoiding the participant*s burden in mind (which is why
Moving Stories has been developed as a serious game).
Da Costakade 45
Utrecht 3521 VS
NL
Da Costakade 45
Utrecht 3521 VS
NL
Listed location countries
Age
Inclusion criteria
In order to participate in the study participant must meet all of the following criteria:
* Participation in the first grade of secondary vocational education
* Providing informed consent
* Informed parental consent when the student is younger than 16 years old
* Sufficient command of the Dutch language;In order to be eligible to participate in the indicated intervention (*OVK MBO*) a participant must meet all of the following criteria:
* Participation in the first grade of secondary vocational education
* Providing informed consent
* Informed parental consent when the student is younger than 16 years old
* Sufficient command of the Dutch language
* Presenting with elevated severity of depressive symptoms (CDI-2 >14)
Exclusion criteria
In order to participate in the study participant must meet not meet the following criteria:
:
* None;In order to be eligible to participate in the indicated intervention (*OVK MBO*) a participant must not meet all of the following criteria:
* Present depression treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65756.091.18 |
OMON | NL-OMON25713 |