Background:
Coping with a chronic illness (CI) challenges children’s psychosocial functioning and wellbeing. Cognitive-behavioral methods may be used to support children with CI and prevent them from developing psychosocial problems. Involving parents in the intervention may enhance the use of learned coping strategies, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called ‘Op Koers’)[1] for children with CI and of a parallel intervention for their parents. A secondary objective is to test potential mediating and moderating factors in order to investigate the underlying mechanisms of the intervention.Methods/design: This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age) with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program) and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population.DiscussionThis study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed.Trial registration: Current Controlled Trials ISRCTN60919570.