The effect of the video game *Mindlight* on anxiety symptoms in children with an Autism Spectrum Disorder.

Anxiety disorders are among the most prevalent mental health disorders in
children, with prevalence rates 3% to 17%. It is the most frequently diagnosed
mental disorder in youth and the earliest to emerge among all forms of
psychopathology . Furthermore, there are many more children suffering with high
levels of anxiety symptoms, but without significant functional impairment they
do not receive a diagnosis .

In the clinical setting, a large proportion of children with an autism spectrum
disorder (ASD) experience anxiety problems. It has been shown that between 11%
and 84% of children with ASD experience some degree of impairing anxiety. More
specifically, research has shown that 21% of the children with ASD suffer from
subclinical anxiety and that approximately 40% of the children with ASD meet
the criteria of at least one anxiety disorder. Some of the most frequently
reported anxiety disorders and symptoms seen in children with ASD are simple
phobias, generalized anxiety disorder, separation anxiety disorder,
obsessive-compulsive disorder and social phobia. Moreover, it has been shown
that anxiety is an underlying factor of several symptoms of ASD. For example,
anxiety has shown to underlie or affect the stereotype or rigid behavior, the
oppositional and aggressive behavior, the depressive symptoms and the problems
in social functioning that children with ASD often show. Furthermore, it has
been reported that anxiety in children with ASD has a negative impact on
adaptive functioning, daily living skills and relationships with peers,
teachers and family.

The above mentioned information shows that it is important that anxiety in
children with ASD is treated and prevented from further escalation. Research
has already shown that the traditional form of cognitive behavioral therapy
(CBT), which is the most frequently used treatment for children with anxiety
problems, is not suitable for children with ASD. This because participating in
traditional CBT-interventions requires the ability to talk about and reflect on
thoughts and feelings, which children with ASD often lack. Therefore, there is
an urgent need for effective modifications of the traditional CBT or
alternative interventions focused on treating anxiety in autistic children.

Recently, it has been shown that video games have the potential to enhance
mental health and well-being in children and adolescents. From this
perspective, the video game Mindlight has recently been developed by a
multidisciplinary team of psychologists, clinicians and game designers. This
game is aimed at reducing anxiety complaints of children. Because Mindlight is
a non-verbal intervention that does not require active introspection, it could
possibly be a good alternative anxiety treatment for children with ASD.
Therefore, the present study will investigate the effect of Mindlight on
(sub)clinical anxiety symptoms in children that are diagnosed with ASD.

The primary objective is investigating the effectiveness of *Mindlight* in
treating (sub)clinical symptoms of anxiety in children who are diagnosed with
an autism spectrum disorder. The secondary objective is to examine the factors
that moderate and mediate intervention outcomes.

The present study is a randomized controlled trial with two conditions
(intervention versus control). This design will be used to investigate the
effectiveness of the intervention game Mindlight.

The intervention that is investigated is called *Mindlight*. This is a video
game aimed at children in the age of 8 - 16 years old and is based on
principles of evidence-based interventions for anxiety-disordered children.
First of all, it uses exposure techniques, one of the most
empirically-validated treatment components of CBT for anxious individuals.
During exposure, individuals are gradually exposed to the threatening cues. In
this way, they are getting habituated to these cues and eventually they are
getting more comfortable and less anxious when being exposed to them. Moreover,
Mindlight uses neurofeedback mechanisms of change, which are based on several
lines of research that have identified evidence-based strategies for decreasing
anxiety. These mechanisms are (a) disattending to threatening cues and shifting
attention away from those cues, (b) focusing on positive aspects of the
environment in the service of relevant goals, and (c) regulating arousal levels
associated with anxiety through relaxation and mindfulness. Altogether,
Mindlight is based on solid grounds of past research finding, which increases
the potential of Mindlight to serve as an effective new intervention for
children with ASD and comorbid (sub)clinical anxiety symptoms.

When children and parents agree with participation after the screening,
children will be randomly allocated to the experimental or control condition.
Children in the experimental condition will play Mindlight for one hour during
6 consecutive weeks at the recruitment location. The researcher will remain
present but children will play the game on their own. When children already
receive or start with a treatment at for example a mental health institute,
they could continue this parallel with Mindlight. Moreover, children, parents
and teachers will fill in questionnaires before, after and at 3-months
follow-up to evaluate the game. Children in the control condition will play
another game ('Max and the Magic Marker') for one hour during 6 consecutive
weeks at the recruitment location, parallel with TAU (if applicable). Moreover,
children, parents and teachers in the control group will also fill in
questionnaires to evaluate the game on the same time points as the children in
the experimental group. Moreover, they will have the opportunity to play the
game after the 3-months follow-up. Finally, parents will undergo a
semi-structured interview (ADIS-P) to examine the presence of anxiety disorders
among the participating children and to evaluate the effect of Mindlight on
these diagnoses.

The potential value of the study is that we can offer 8-16 year old children
with ASD and comorbid (sub)clinical anxiety an intervention that is proven to
be effective in treating their anxiety symptoms. In order to achieve this goal
we need to evaluate the effectiveness of this intervention in this specific
population (8-16 years old, diagnosed with ASD and anxiety symptoms).
However, we are of opinion that the risks associated with participation are
minimal. Mindlight is based on solid grounds of past research findings on
evidence-based treatments of anxiety (e.g. exposure therapy). In this way, the
risks associated with participation can be considered negligible. The burden of
the study for both children and parents consists of filling in questionnaires
and participating in a clinical interview. To determine whether the
intervention contributes to reducing anxiety, we have to determine whether the
program has a significant effect on the anxiety complaints of the participating
children. The possible risks and burdens for the participants might lead to a
new evidence-based anxiety intervention for children with autism.