Effect of the serious game 'You & I' on the mentalizing abilities of adults with mild to borderline intellectual disabilities: A randomized controlled trial

*Seeing oneself from the outside and others from the inside.* A phrase that is
commonly used to describe the term mentalization. Mentalization refers to *the
mental process by which an individual implicitly and explicitly interprets the
actions of himself or herself and others as meaningful on the basis of
intentional mental states such as personal desires, needs, feelings, beliefs,
and reasons* (Bateman & Fonagy, 2004). It is a fundamental human ability that
allows us to understand our own behavior and the behavior of others in terms of
mental states (Fonagy, 2006). In relation to the self, the ability to mentalize
enables the development of a stable sense of identity, essential to the
regulation of strong emotions, such as stress (Fonagy, Gergely, Jurist, &
Target, 2002). On the other hand, in relation to others, the ability to
mentalize is crucial for the establishment of healthy reciprocal social
relationships (Allen, Fonagy, & Bateman, 2008).

Persons with mild to borderline intellectual disabilities (MBID) generally show
reduced abilities to mentalize (Baglio et al., 2016; Yirmaya, Erel, Shaked, &
Solomonica-levi, 1998; Owen, Browning, & Jones, 2001). This inadequacy results
in a number of difficulties experienced by this population, including a poor
sense of self, no constructive social interaction, no reciprocity in social
relationships and a poor regulation of emotions, including stress (Fonagy,
2006). Empirical evidence (Busch, 2008) suggests, however, that mentalizing
abilities can be improved with treatment programs such as mentalization-based
therapy (Bateman & Fonagy, 2004). So far, these treatment programs have mainly
focused on persons with borderline personality disorders, while methods to
support the acquisition of mentalizing abilities for persons with MBID are
still lacking. Yet, it seems particularly important for this population to
enhance mentalization, as persons with MBID face many difficulties related to
the mentalization deficit, such as small social networks and poor emotion
regulation skills (Bigby, 2008; Mcclure & Donahue, 2009).

A promising method to improve mentalizing abilities of people with MBID is
serious gaming (Connoly, Boyle, MacArthur, Hainey, & Boyle, 2012). Serious
games are computer applications that combine serious aspects, such as learning,
with playful gaming elements (Alvarez & Djaouti, 2011). Serious games have
become increasingly popular over the last years and results on their
effectiveness are promising (Connoly et al., 2012). Studies have shown that
serious games can be deployed successfully in the care for persons with
intellectual disabilities when it comes to learning new skills and when it
comes to the development of abstract concepts (Den Brok & Sterkenburg, 2014).
Moreover, serious games are cost-effective and provide a unique learning
environment wherein persons are allowed to practice new skills in a setting
that is unlikely to be realized in their daily lives (Cheng, Chen, Cu, & Chen,
2015).

To address the intervention gap in clinical practice, the serious game *You &
I* has been developed. The game is intended to improve mentalizing abilities,
including the regulation of stress, in adults with MBID. For scientific
relevance, the efficacy of the serious game will be investigated, answering the
following research questions: Is the serious game *You & I* efficacious in
improving mentalizing abilities in adults with MBID compared to a wait list
control group? Is the serious game *You & I* efficacious in improving the
regulation of stress in adults with MBID compared to a wait list control group?

In addition, research will be conducted into the serious game 'You & I' in a
research group of adults with MBID who played the serious game together with
their caregiver. Although the game is ideally suited to be played only by
adults with MBID, adding a social link (some kind of social support) can
improve the process of behavioral change (Sort & Khazaal, 2017). For adults
with mild to borderline intellectual disabilities, care providers regularly
provide (social) support and their involvement in playing a serious game can
benefit the learning experience of this group. Moreover, previous research by
Witvliet et al. (2015) and Douma (2018) has shown that caregivers can motivate
people with MBID and increase their self-confidence while performing a task.
The accompanying research questions are therefore: Is the serious game 'You &
I' more efficacious in improving mentalizing abilities in adults with MBID when
they play the game together with their supervisor compared to playing the game
alone or the waiting list control group? Is the serious game 'You & I' more
efficacious in improving the regulation of stress in adults with MBID when they
play the game together with their supervisor compared to playing the game alone
or the waiting list control group?

The first objective of this study is to research the efficacy of the serious
game *You & I* in improving mentalizing and stress regulating abilities of
adults with mild to borderline intellectual disabilities compared to a wait
list control group. The primary research question of this study is: Is the
serious game *You & I* efficacious in improving mentalizing abilities in adults
with mild to borderline intellectual disabilities compared to a wait list
control group? The secondary research question of this study is: Is the serious
game *You & I* efficacious in improving the regulation of stress in adults with
mild to borderline intellectual disabilities compared to a wait list control
group?

The second objective of this study is to research the efficacy of the serious
game *You & I* when the game is played by adults with mild to borderline
intellectual disabilities together with their caregiver. The primary research
question is: Is the serious game *You & I* more efficacious in improving
mentalizing abilities in adults with mild to borderline intellectual
disabilities when playing the game together with caregivers compared to playing
the game alone or the wait list control group? The secondary research question
is: Is the serious game *You & I* more efficacious in improving the regulation
of stress in adults with mild to borderline intellectual disabilities when
playing the game together with caregivers compared to playing the game alone
or the wait list control group?
Moreover, the aim is here also to gain (more) insight in the process of jointly
playing the serious game 'You & I' by caregivers and adults with mild to
borderline intellectual disabilities. It is expected that caregivers also apply
what is central and is taught in the serious game in their help to the clients
while playing the serious game. Therefore, the additional research question is:
To what extent do caregivers support learning by promoting mentalization while
playing the serious game *You & I* with adults with mild to borderline
intellectual disabilities?

The first research question will be answered using a two arm parallel
superiority randomized controlled trial (RCT). The RCT includes an experimental
group, who will be offered to play the serious game *You & I*, and a wait list
control group, who will get the chance to play the serious game after the
follow up measurement. Both participants and researchers are not blinded, as
this is not possible due to the design of this study. Thus, both the
participants and the researchers know which group the participants have been
assigned to.

The second research question will be answered using a single-arm trial in which
clients play the serious game 'You & I' with their caregivers. Because this
single-arm trial will start later than the RCT, the participants in this study
will be matched with the participants in the RCT. To gain (more) insight into
how the participants play together with their caregivers, the caregivers will
be asked to make two audio recordings.

The intervention is a serious game called *You & I* that focuses on the
improvement of mentalizing abilities, including the regulation of stress. The
game was developed by experienced researchers in the period of June 2017 until
August 2018. The serious game is based on the attachment theory (Bowlby, 1982),
the practice-oriented book *Mentalization can be learned* (in Dutch:
*Mentaliseren kan je leren*) by Dekker & Sterkenburg (2015) and the
practice-oriented book *Mentalization in clinical practice* (in Dutch:
Mentaliseren in de klinische praktijk) by Allen, Fonagy & Bateman (2008).

The game consists of eight gaming levels, which will take about 30 to 45
minutes to complete. The participant is asked to play the game twice a week, so
it takes four weeks to complete the game. Each level has the same structure
consisting of six different gaming elements, such as a memory game, videos,
questions, puzzles and statements.

To test the efficacy of the serious game *You & I*, multiple measures are
included in the design. At every assessment, participants are asked to fill out
several questionnaires. These questionnaires will take up to 1.5 hours each
time. Participants who are assigned to the experimental group have to play the
serious game *You & I* twice a week for 30 to 45 minutes throughout 4 weeks.
The two audio recordings that are made during the playing moments of the group
participants who play together with their caregiver, take little to no extra
time.

The burden of the participants can be considered in proportion to the potential
benefits of the research project for the subject. We expect an improvement in
mentalizing abilities and stress regulation. Participants in the control
condition encounter the same possible benefits as the participants in the
experimental conditions because they are invited to play the serious game *You
& I* after the follow-up assessment.

No risks are expected.