Effectiveness of a cognitive-behavioral based group intervention for children with chronic disease: A randomized controlled trial.

Children with a chronic illness (CI), like asthma, diabetes, sickle cell
anemia, cystic fibrosis, and
inflammatory bowel diseases, are twice as likely to develop psychosocial
problems as healthy children.
About 25% of children with a chronic illness need any mental health services.
To adequately prevent
children with CI from developing psychosocial problems, evidenced based
intervention programs are
needed. However, in the Netherlands, these programs do not exist. As a first
effort, in the Emma
Kinderziekenhuis AMC, a standardized group-based intervention program was
developed, called Op
Koers. Based on cognitive-behavioural principles, children learn to use skills
to help them to cope with
the consequences of their disease. Children that participated in Op Koers
reported significant
improvement of social-emotional functioning than before the intervention.
Parents were, however, not
involved in this program, while they may be the best support of their ill
child. To enhance the effect of
intervention, a complementary program for parents called Samen Sterk was
developed. Samen Sterk is
aimed to support parents in encouraging their children in using learned
cognitive skills, which may be
especially important for achieving long term effects. Samen Sterk is expected
to strengthen the
intervention effects of Op Koers, enhancing the positive effects of
intervention on the adjustment of
children with CI.

Effects will be evaluated in a randomized controlled design. First, the effects
of Op
Koers on social-emotional outcomes will be compared with a control group.
Secondly, the additional
value of Samen Sterk will be investigated in relation to both conditions.
Effects of the different conditions
will be investigated in a moderate (6 months) to long term (12 months)
schedule. Five hospitals will
cooperate in this study to provide a sample size sufficient for comparing
effects of interventions and to
explore whether the intervention will catch on in academic as well as
non-academic medical settings. If
proven effective, Op Koers will be made available to all medical centers. The
ultimate goal of this study
is that children with a chronic illness and their parents will have access to
an evidence based program
that limits the mental health consequences of their physical health.

The design includes a randomized control trial with three groups: 1) control
group (waitlist), 2) child
intervention Op Koers, 3) child intervention Op Koers combined with parent
program Samen Sterk.
Groups will be stratified according to age, because of differences in cognitive
development. The
recruitment of children and their parents, as well as conducting the group
intervention will be done in
co-operation with five participating hospitals. Supervised by the main
researcher, local psychologists at
each hospital are involved with informing medical staff and participants and
the organization of the
assignment procedure. A post-doc researcher (part-time) and a PhD student are
involved with the
organization and coordination of the project, and with analyzing the data and
reporting and implementing
the results of the study.
Longitudinal analyses (linear mixed model analysis) will be performed to test
the effects of the
intervention (primary and secondary hypothesis). In secondary analyses,
moderator variables will be
included to investigate whether the intervention effects are associated with
characteristics of the child
and the family (gender, age, medical diagnosis, severity of disease, attendance
during group sessions).

Op Koers is based on techniques proven to be effective in behavioral and
cognitive behavioral programs
in children with somatic complaints (Kibby et al., 1998) and in children with
behavior and/or anxiety
disorders (Kendall, 1991). Four learning goals are central in Op Koers: 1)
information seeking and
information giving about the disease (*good to know better* principle), 2) use
of relaxation during
stressful situations (using exercises), 3) enhancement of social competence
(group discussions, role
playing), and 4) positive thinking (Effecive use of the Thinking-Feeling-Doing
model; replacement of
inaccurate thoughts).
The parent intervention *Samen Sterk* is built on existing cognitive behavioral
programs for parents of
children with anxiety problems (Barrett et al., 1998; Wood et al., 2006).
*Samen Sterk* fits into the
learning goals of Op Koers. The program combines cognitive behavioral
strategies with parenting
behavior training, focusing on positive responsiveness and autonomy granting,
including: a) promoting
and supporting children*s acquisition of novel self-help skills, b) labeling
and accepting children*s
emotional responses (rather than criticizing them), c) allowing children to
struggle and learn by trial and
error rather than taking over for them, and d) giving choices (rather than
making choices for the
children). Primary purpose of the parental module is enhancing treatment
effects of the children*s
program, by teaching parents to encourage their children in using the learned
strategies. Secondary goal
of Samen Sterk is to encourage parents to take a positive attitude towards
granting autonomy to their
children, so that children will actually receive the opportunity to exercise
their learned skills by
themselves. Overall, the parent interventions are intended to enhance
availability of parental support as
perceived by the children, expected to result in increases in children*s
perceived self-efficacy and in the
implementation of coping skills, related to their disease and treatment, which
in turn will improve
social-emotional functioning in children with CI.

The burden for the participants consists of completing the questionaires. The
amount of time is 45 minutes each occasion. There are no risks for patients or
their parents.