Tandem study: The effectivity of Theraplay on children with autism spectrum disorder and their parents.

Evidence-based treatment methods based on randomized controlled trials for
children with ASD are scarce. Moreover, there is hardly any research regarding
interventions for children with ASD in which the mental and physical health of
their parents is included as a treatment goal. Chronic distress in parents
having a child with ASD, can lead to severe mental and physical health
problems, with increased mortality as a consequence. Furthermore the use of a
biomarker for treatment effectiveness in children with ASD is not available.

In this study the three-dimensional approach is central in the treatment. The
treatment is focused on 1) the child with ASD, 2) the parents, 3) the
parent-child relationship, instead of the current one-dimensional approach.
Instead of treating parents as an extended version of their child, we take the
health of the parents as a treatment goal and as an essential factor in the
well-being of the child with ASD.

Randomized controlled trial (RCT) in which one group will receive Theraplay and
the other group will receive treatment as usual (TAU).

Theraplay is a directive play intervention based on the attachment theory. It
is a semi structured treatment method. Before every Theraplay trajectory a
MIM-NL-II trajectory is performed. This is a structured parent-child
observation specifically developed to set the goals within the Theraplay
trajectory. In response to the MIM-NL-II the content of the Theraplay sessions
will be composed. The Theraplay goals are discussed with the parents during the
MIM-NL-II feedback session. Followed by a parent session in which parents
receive information about translating the goals of the MIM-NL-II to the
Theraplay sessions. Moreover, parents undergo several Theraplay activities in
preparation for the Theraplay trajectory. Thereafter parent and child have a
weekly Theraplay session of approximately 45 minutes. The duration of the
sessions can vary, depending on the concentration span of the child. After
every three Theraplay sessions a parent feedback session is planned in which
the goals of the Theraplay trajectory are evaluated. Besides Theraplay, also
psychoeducation and parent guidance is provided during the parental sessions.
Parents and the Theraplay therapist decide during the parent feedback sessions
whether the Theraplay trajectory will be continued or finished depending on the
goals being achieved. An average Theraplay trajectory lasts 26 sessions,
approximately 8 months.

Treatment as usual (TAU) consists of psychoeducation regarding ASD followed by
parent guidance sessions. During the guidance sessions parents learn to apply
the information from the psychoeducation regarding their child with ASD.
Additionally other forms of treatment, such as pharmacotherapy can be applied.
TAU will also have a duration of on average 8 months.

See the researchprotocol for an extended clarification of the intervention
including references at: Treatment of subjects

Participants of the study receive treatment in one of the two research-groups:
Theraplay or TAU, both of similar
duration. Three times during the researchperiod of one year, measurements are
made. Namely, before start of the
study (T0), 6 months (T1), and 12 months after start of the study (T2). During
the visit, measurements of the child and
parents consist of: video-observations (free play and an ADOS-2), physical
measurements (height and weight) and
hair-cortisol which will be obtained by cutting of a small piece of hair on the
back of the head. Parents will undergo
some extra physical measurements: waist circumference, blood pressure and
simultaneously heartrate. Prior to these
measurements parents fill in a set of questionnaires at home and a blood sample
is taken. In addition to these
measures, before the start of the study (T0) and after start of the study (T2),
a small quantity (size of a marble) of stool
and salvia (1 ml) will be obtained from 50 children and their parents. The
teacher or day-care facilitator of the child will
complete two questionnaires about observed behaviour of the child. At last,
prior to every therapy session parents
complete two short computerised questionnaires, which will take up to a maximum
of 10 minutes each time. In our
opinion participating in this study will not pose evident risks upon the
participants. It is mainly a time-investment we ask
from the parents and the children to fill in questionnaires by parents and to
perform measurements on the parents and
their child.