Online cognitive-behavioral based group interventions for adolescents with chronic illness and parents: study protocol of two multicenter randomized controlled trials.

BACKGROUND: Adolescents with chronic illness (CI) and parents of a child with CI are at risk for psychosocial problems. Psychosocial group interventions may prevent these problems. With the use of cognitive-behavioral therapy, active coping strategies can be learned. Offering an intervention online eliminates logistic barriers (travel time and distance) and improves accessibility for participants. Aim of this study is to examine the effectiveness of two cognitive-behavioral based online group interventions, one for adolescents and one for parents: Op Koers Online. The approach is generic, which makes it easier for patients with rare illnesses to participate.

METHODS/DESIGN: This study conducts two separate multicenter randomized controlled trials. Participants are adolescents (12 to 18 years of age) with CI and parents of children (0 to 18 years of age) with CI. Participants are randomly allocated to the intervention group or the waitlist control group. Outcomes are measured with standardized questionnaires at baseline, after 8 (adolescents) or 6 (parents) weeks of treatment, and at 6- and 12-month follow-up period. Primary outcomes are psychosocial functioning (emotional and behavioral problems) and disease-related coping skills. Secondary outcomes for adolescents are self-esteem and quality of life. Secondary outcomes for parents are impact of the illness on family functioning, parental distress, social involvement and illness cognitions. The analyses will be performed according to the intention-to-treat principle. Primary and secondary outcomes will be assessed with linear mixed model analyses using SPSS.

DISCUSSION: These randomized controlled trials evaluate the effectiveness of two online group interventions improving psychosocial functioning in adolescents with CI and parents of children with CI. If proven effective, the intervention will be optimized and implemented in clinical practice.

TRIAL REGISTRATION: ISRCTN ISRCTN83623452 . Registered 30 November 2017. Retrospectively registered.