Effectiveness of an online cognitive behavioral group intervention for adolescents with a chronic disease and parents: A randomized multicenter controlled trial

In the Netherlands, the estimated prevalence of children and adolescents with a
chronic illness is 500.000 (14%). The term *chronic illness* refers to a
medical condition that is not (yet) curable and the illness exists for at
least three months and doesn*t cure spontaneously. Children and adolescents
with a chronic illness often face uncertainty about the future, frequent
hospital visits, medical treatment, fatigue, limitations when participating in
social and/or sport activities and absenteeism at school. These aspects have a
big influence on the daily functioning of these children and adolescents. Due
to this, they are at heightened risk for psychosocial problems such as anxiety,
sadness, social withdrawal and adaptation problems. Consequently, these
problems can have a negative influence on their possibilities to develop in the
same way peers do and to participate in society.
Parents of children and adolescents with a chronic illness experience more
worries and stress because of intensified care taking and emotional pressure
then parents whose children are healthy. Besides the intensified
social-emotional support that parents are supposed to give to their child with
a chronic illness, the relationships with other household and family members,
friends and colleagues can become more tensed.
In short, not only the child with a chronic illness is affected by the
consequences of the illness. The resilience of all members in the household is
tested. By strengthening the core, meaning the child with the chronic illness,
and the layer that encloses this core, meaning the household, this will have a
positive reciprocal effect on the wellbeing of the child as well as on the
important supportive surroundings. For that reason attention is needed to
prevent psychosocial problems in these vulnerable children and their family
members. However, easy accessible evidence-based healthcare for this target
group is lacking. Online interventions are easy accessible and lower down
barriers for healthcare. Additionally, research shows that online interventions
are as effective as face-to-face interventions.
This study will show whether adolescents with a chronic illness and/or parents
will profit from participating in the Op Koers Online courses. Considering the
positive effects of the face-to-face program, we expect that Op Koers Online
will have a positive effect on psychosocial wellbeing. We expect that
psychosocial functioning of adolescents and parents in the intervention will
improve.

The main objective of the study is to research the effectiveness of two online
cognitive behavioural therapeutic courses; a course for adolescents with a
chronic illness and a course for parents of children and adolescents with a
chronic illness. The following research questions will be leading when
determining effectivity:
1. Does participation in Op Koers Online for adolescents with a chronic illness
have a positive effect on psychosocial functioning of the adolescent?
2. Does participation in Op Koers Online for parents have a positive effect on
psychosocial functioning of the parent?

Research on Op Koers Online for adolescents and Op Koers Online for parents
will be conducted in two separate randomised controlled multicentre trials with
two conditions: intervention condition (Op Koers Online) and waiting list
condition. This design offers the opportunity that multiple family members from
one family can participate in the research. However, this is not required.
Earlier studies on the effectiveness of Op Koers and comparable effect studies
showed moderate effects. Based on a repeated measures design with four measure
points in time and a within subject correlation of 0.5, 84 adolescents and 84
parents are needed to show a moderate intervention effect (d=0.05) over time,
with a two-sided 0.05 significance level and 80% power. Taking into account a
dropout of 15% over time, 96 adolescents and 96 parents need to participate to
meet the intended power. Due to this, 48 adolescents and 48 parents will be
randomised in the intervention group and the same amount will be randomised in
the waitlist condition. When on average five participants are in one course,
there will be 10 courses for adolescents and 10 courses for parents in the
intervention condition.

A total of 66 young people and 81 parents were included. Based on the expected
drop-out rate of 15%, we will be able to include the outcomes of at least 56
young people and 69 parents in the analysis. This is realistic based on the
data collection until 26 November 2018. We performed new power calculations.
We have performed power calculations based on the smaller than intended sample
size numbers. The smaller sample number does not have any major adverse
consequences.
For the adolescents the power is 65%, instead of the desired 80%, to be able to
demonstrate a difference of 0.5 SD between intervention and control group.
However, we are able to demonstrate a difference of 0.6 SD, instead of the
target 0.5 SD, with a power of 80%.
For the parent intervention the power is 75%, instead of the desired 80%, to be
able to demonstrate a difference of 0.5 SD between intervention and control
group. However, we are able to show a difference of 0.53 SD, instead of the
intended 0.5 SD, with a power of 80%.

In total, nine hospitals will participate in the study
Emma Children*s hospital AMC (Amsterdam),
VU Medical Centre (Amsterdam),
De Kinderkliniek (Almere),
Antonius Hospital (Sneek),
Jeroen Bosch Hospital (*s-Hertogenbosch),
Deventer Hospital (Deventer),
Canisius-Wilhelmina Hospital (Nijmegen),
Hospital St Jansdal (Harderwijk) en
Scheper Hospital (Emmen).

The peripheral hospitals and the VU Medical Centre will give one course for the
adolescents and one for the parents each. The Emma Children*s hospital will
give two courses for the adolescents and two for parents in the intervention
condition. In every hospital, participants will be invited to participate in
the study through an invitation letter. When do agree to participate,
adolescents will have an intake by phone and parents will have a face-to-face
intake. After intake, the randomisation will be conducted. Participants will be
randomised in the intervention or waitlist condition. In case the participant
is randomised in the intervention condition, he/she will start the course in
October 2016 (adolescent) and January 2017 (parent). If the participant is
randomised in the waiting list condition, the participant is able to do the
course one year later when effectiveness is proven.

At four points in time, all participants fill in online questionnaires at
www.opkoersonline.nl; before randomisation, directly after the course, directly
after the booster session (six months after baseline) and 12 months after
starting the course.
We use intention-to-treat analyses. Longitudinal multilevel analyses (SPSS:
linear mixed model analyses) with raw data will be performed to measure the
effect of the intervention (primary and secondary hypotheses). With explorative
analyses, possible effects on the raw data of the secondary outcomes of
adolescents and parents will be measured.

All Op Koers Online courses will be given in a secured chat environment and a
secured chat box, in which participants log in every week at the same time. Op
Koers Online for adolescents consists of eight sessions (weekly) and one
booster session (6 months after the start of the course). Op Koers Online for
parents consists of six sessions (weekly) and one booster session (6 months
after the start of the course).

Participants are able to do their homework assignments in between the sessions,
in their own chat environment. De assignments suit the sessions and become
available after each session. Apart from the sessions in the chat box, parents
are not able to chat with each other. The courses are guided by one healthcare
psychologist and one co-therapist, who use a detailed manual. Every session
lasts 1,5 hour.
Op Koers Online is based on techniques proven to be effective in behavioural
and cognitive behavioural programmes. A specific model is used to explain to
participant how thoughts, feelings and behaviour is related to each other and
influences each other. This *thinking-feeling-doing* model makes it possible to
recognise negative thoughts and feelings and helps to learn new behaviour.

In the course for adolescents, four learning goals are the focus of attention:
1) searching information and giving information about your illness (*it is
better to know*-principle), 2) use of relaxation techniques during stressful
situations (relaxation exercises), 3) enlarging social competences (video*s and
group discussions) and 4) positive thinking (*thinking-feeling-doing*-model and
detecting worrying thoughts).

In the course for parents, every session a certain *circle* in which the parent
lives, is the focus of attention. To match the course to the needs of parents,
themes in a particular circle that are relevant to the participating parents
are discussed in the chat session. To make the course as effective as possible,
the focus lies more on amassing independently compounding information. They can
access this information in their personal online environment. Per session,
parents can find a summary of the themes that have been discussed, tips that
parents gave each other psycho-education and assignments. These assignments
serve a transition goal to bring the learned active coping skills in practice.

The intervention is not invasive and there is no external pressure that is out
of control for the adolescent and/or parent. Op Koers Online is focused on
enlarging personal skills. The intervention will be offered online and
participants can participate when they are at home. Adolescents do not need to
travel to participate in the intervention. Parents only travel once to the
hospital, if they want the acquaintance to be face-to-face, otherwise it will
be done on the phone. Parents can also participate in the intervention when
they are at home. The interventions consist of 7 or 9 sessions, with a duration
of 1,5 hour. Our experiences with Op Koers Online show that it is much
appreciated by participants that they do not need to travel to be able to
participate. As a result, adolescents have less school absenteeism and for
parents it*s more easy to combine with their work. Risk are negligible for the
adolescents and parents. The burden with participation is minimal; the burden
for participants consists of completing questionnaires. The amount of time is
45 minutes each occasion.
The study can only be done with cooperation of pediatric patients. Only if we
include adolescents with a chronic illness and parents of children and
adolescents with a chronic illness, we are able to study the effect of Op Koers
Online in these groups.