The primary objective of the current study is to evaluate the efficacy of a multimodal prevention program for adolescents. The secondary objective of the study is to investigate which child factors might mediate the efficacy of the program and…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Suicidal behavior
Secondary outcome
Depression
Stigma
Mastery
Social identity
Worry
Life Events
Perfectionism
Schoolrelated factors such as academic grades, drop-outs, truancy and
non-attendance
Background summary
Since 2010 suicide is the leading cause of death among 15-29 year olds.
Depression is the most important risk factor associated with suicide.
Therefore, prevention of suicide ought to be in conjunction with reducing the
risk of depression. Depressive symptoms and suicidal behaviour could lead to
self-injurious behaviour, substance abuse, learning disabilities, social
problems and obesity. These, in turn, lead to declining school results and
school dropout. Moreover, the costs associated with depression and suicidality
are quite high.
Often depressive symptoms and suicidal behaviour are not recognized in
adolescents and remain untreated for an extended period. This is not a problem
exclusive to health care or so-called gatekeepers (schoolteachers), but is also
very common among youth themselves. Help-seeking behaviour in youth is lower
than any other age group. Part of this problem is due to stigma and feelings of
self-reliance among adolescents. Therefore it is imperative to prevent these
feelings among youth and increase help-seeking intentions and behaviour while
increasing knowledge about when they should seek help. Despite all these known
facts the prevention of suicide and depression is still underappreciated.
Apart from increasing knowledge and reducing stigma it is important to know
which adolescents already experience depressive symptoms and are on the road to
develop a clinical depression. This helps us to give these students the right
tools to reduce the risk of the development of a clinical depression and in
turn suicidal behaviour.
Given the prevalence, negative outcomes associated with depression and health
care costs of depression it is crucial to implement a multimodal prevention
program that reduces the risk of depression and suicidal behaviour.
Study objective
The primary objective of the current study is to evaluate the efficacy of a
multimodal prevention program for adolescents. The secondary objective of the
study is to investigate which child factors might mediate the efficacy of the
program and predict outcome.
Study design
The current study is a cluster randomized controlled trial (RCT) containing two
conditions to evaluate the efficacy of a multimodal prevention program.
Furthermore, adolescents with acute suicide risk shall be monitored using
questionnaires.
Intervention
The multimodal prevention program consists of four modules in total. Both the
intervention and control condition will be screened for suicide risk and in
case of acute suicide risk the student will be referred to mental health care.
Furthermore, all mentors of participating school will be trained as gatekeepers
in order to recognize suicidal behaviour. These modules will not be evaluated
as they are equal in both conditions.
The intervention that will be evaluated consists of two modules, namely a
universal and an indicated module. Both modules will only be offered to schools
in the intervention condition.
The universal module that will be evaluated is called *Moving Stories*. It is a
serious game that students will play using their smartphones for five
consecutive days, approximately 10 minutes a day, and two mentor classes of
approximately one hour each. During the first mentor class the mentor explains
to the students how to download and play the app. They are also told that even
though the entire class will play this game at the same time, it is an
individual game and no one is able to see their actions in the game. Then, it
is explained that the students will virtually spend five days with their
cousin, Sanne, and she will not come out of bed. Students are expected to help
Sanne feel better and maybe even get out of bed. Then, they will receive
background information about Sanne, her family and the students* relationship
with Sanne. After the mentor class the game can begin. Once the students have
gained access to the game, they will find themselves in a virtual house (on
their phones*) where they can walk around, can execute several actions and talk
to Sanne. Every morning the student has approximately 10 minutes to talk to
Sanne and execute actions. They are allowed to execute only 10 actions. During
the afternoon virtual Sanne will send them text messages containing feedback
about the actions they executed that morning. The ultimate goal of the app is
that students learn that Sanne is in fact depressed and that the only action
that will help Sanne with her depression is to call upon an adult. After the
five days of app playtime a second mentor class shall be organized. During this
class an experienced expert (who has suffered from depression in the past) will
explain that Sanne was depressed and what it means to be depressed, how it is
different from being sad and what adolescents should do if they experience
these complaints or recognize these complaints in someone else. Also, there
will be plenty of time for the students to talk about their experiences in the
app and how they felt while playing the app.
The indicated module that is evaluated is called 'Op Volle Kracht'. It consists
of 8 lessons of each 60 minutes. The intervention is based on the principles of
cognitive behavioral therapy (CBT). During the first lesson, the participants
learn about emotions and depressive feelings. The adolescents learn which
emotions they experience and how they can recognize them. During this program,
they will use a schedule to find out that activating events, beliefs, emotional
consequences and behavioral consequences are related. During the second lesson,
the adolescents learn about the relationship between activating events, beliefs
and emotional consequences. Beliefs can be either optimistic or pessimistic and
play a major role in the emotional consequences. The adolescents learn how they
can recognize pessimistic beliefs. Throughout the third lesson, adolescents
learn how they can recognize the pattern of their beliefs and cognitive errors.
During the fourth lesson, adolescents learn to investigate their thoughts and
to find evidence in favor of and against their thoughts. Throughout the fifth
lesson, adolescents continue to find evidence in favor of and against their
thoughts and start to test whether their thoughts are actually true. During the
sixth lesson, participants investigate their thoughts by asking the question
'what's next?* They learn to question their thoughts by fantasizing about the
worst case scenarios of their thoughts. In addition, they learn to create an
action plan to prevent that the worst case scenario will actually occur. During
the seventh lesson, adolescents learn how they can replace non-helping thoughts
and how they can prove the alternative belief is true. The eight and last
lesson is meant to finish the intervention on a fun note. Adolescents can share
their experiences about the intervention and participate in a quiz about
everything they learned. An application is designed to support the OVK program.
In this app, adolescents can manage their homework and monitor their mood.
Study burden and risks
The potential value of the study is that adolescents with suicide risk will be
identified sooner and in turn can be referred to mental health care. Also
help-seeking behaviour will be stimulated by the universal module and
adolescents with increased depressive symptoms will be identified and offered
an indicated prevention module that is effective. To evaluate the effectiveness
of this program within this specific population, adolescents between 11-15
years old, the study should use a study population that meets these criteria.
The risks associated with participation can be considered negligible. The
burden of the study lies within completing questionnaires and playing an app on
their smartphones. Both prevention modules will furthermore be completed during
school hours. To determine whether this prevention program is effective and
contributes to wellbeing of adolescents, we need to evaluate the program among
adolescents. The risks associated with participation may provide for a more
effective prevention program.
Berlicumseweg 8
Rosmalen 5248 NT
NL
Berlicumseweg 8
Rosmalen 5248 NT
NL
Listed location countries
Age
Inclusion criteria
adolescents are aged between 11-15 years old
sufficient knowledge of the Dutch language
Exclusion criteria
absense of permission
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL61559.091.17 |