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

Children and adolescents with a chronic illness (CI) have to face difficulties related to their illness, such as hospitalization, the use of medication, restrictions in activities and stressors related to the course of the illness and the future [1‐3]. In the Netherlands, 14% of children and adolescents is growing up with a CI (for example diabetes, asthma or Cystic Fibrosis) [4]. Growing up with a CI influences psychosocial wellbeing and the development of cognitive and social skills [2, 5‐7]. Especially during adolescence, with the formation of identity, self-image and self-esteem, a CI constitutes a major challenge [8, 9].

Research shows that pediatric CI influences psychosocial wellbeing in parents as well [10, 11]. Parents are predominantly responsible for managing the child’s illness. They are confronted with stressors about their child’s health as well as logistical and practical factors such as managing daily routines, relationships with other family members, the balance between family and work and possible financial problems [11, 12]. Therefore, parents are at risk for sorrow and psychosocial distress [10, 12]. Parents who face stress are less able to manage the child’s illness effectively [11]. To prevent and/or to reduce psychosocial problems in parents as well as adolescents, interventions focusing on how to cope with stressors caused by the CI are needed [13].

The disability-stress-coping model states that stressors related to the illness and psychosocial adjustment of children and mothers are moderated by coping strategies and cognitive appraisals [14]. Moreover, research has shown that effective use of coping skills increases adolescents’ medical compliance, improves their psychosocial functioning [2, 15‐20] and reduces distress and anxiety in parents [21, 22]. Results on the effectiveness of cognitive-behavioral based psychosocial group interventions to learn children and adolescents how to use more effective coping skills are promising [23‐25]. Research shows that including parents in a psychosocial intervention for children with chronic pain is effective in reducing child’s pain [22]. There is some evidence of effectiveness of interventions focusing on parents themselves: coping support interventions reduce parental psychological problems during acute hospitalization [21] and problem solving therapy for parents improves parental mental health [22]. However, little is known about the effectiveness of cognitive-behavioral based psychosocial group interventions for parents focusing on themselves.

In 2003, the face-to-face cognitive-behavioral based group intervention Op Koers (English: On Track) for children and adolescent with CI was developed in the Emma Children’s Hospital (Academic Medical Center Amsterdam). Over the years, the program was expanded with courses for siblings and parents, and a similar Op Koers program for pediatric oncology patients. Goal of Op Koers is to prevent and/or to reduce psychosocial problems of participants by teaching active coping skills with the use of cognitive-behavioral therapy (CBT) techniques [26]. The approach is generic, which means that patients with every type of CI can participate. This has the benefit of giving more patients at once the opportunity to participate and to include patients with rare illnesses in group interventions [23, 26]. Sharing experiences with others in a similar situation had been associated with a decrease of distress and improvement of social health [23, 27‐29] and is therefore an important part of Op Koers. There have been different studies about this intervention program [26, 30, 31]. Part of the research has been an RCT on the efficacy of Op Koers for children and adolescents with CI. This study showed positive short- (half year) and long-term (one year) effects on the use of coping skills and psychosocial functioning. For children and adolescents, there was an additional positive effect of parental involvement, especially on long-term and in social-emotional vulnerable children [32‐34].

The face-to-face setting of Op Koers requires participants to regularly come to the hospital, in addition to other medical appointments. An online intervention eliminates logistical barriers such as travel time and distance [35, 36] which makes the intervention more easily accessible [35, 37, 38]. Participating in an intervention online connects to the digital environment in which people live nowadays. Besides, an online environment without use of a webcam increases anonymity: appearance plays no role and this might make it easier to talk about problems [38‐40]. Therefore, Op Koers was translated into an online intervention: Op Koers Online.

First, the intervention for survivors of childhood cancer was developed. A pilot study on the feasibility of Op Koers Online Oncology for adolescent survivors showed promising results [39]. The intervention was optimized based on feedback from participants and course leaders (for example: expanding the sessions from six to eight). After that, Op Koers Online for adolescents with CI was developed. Similar to the face-to-face intervention, goal is to prevent and/or reduce psychosocial problems by teaching the use of active coping skills with CBT techniques. Sharing experiences with other chronically ill adolescents is an important part of the intervention. First pilot results on the feasibility and potential effectiveness of Op Koers Online for adolescents with CI are promising (Douma et al.: Feasibility and effectiveness of an online cognitive-behavioral based group intervention for adolescents with chronic illness, submitted).

For parents, most existing interventions focus on the child’s functioning [13, 22]. The same applies to Op Koers face-to-face for parents, where participating parents learn what their child learns and how to support their child in implementing coping skills in daily life [32, 34]. However, research suggests the need of emotional, informational and peer support for parents [41, 42]. For the development of Op Koers Online for parents, the Emma Children’s Hospital (Academic Medical Center, Amsterdam) conducted a survey among parents on their specific wishes and needs. The need for an intervention focusing on parental functioning instead of focusing only on the child emerged from the survey. Based on the results of this survey, Op Koers Online for parents of children with CI was designed.

This paper outlines the study protocol for two multicenter randomized controlled trials on the effects of two cognitive-behavioral based online group interventions: one for adolescents with CI and one for parents of children and adolescents with CI. Earlier studies showed that psychological interventions for children and adolescents with CI, and for parents, can improve psychosocial functioning [22, 23, 32]. Also, studies on effectiveness of online interventions showed promising results [40, 64‐66]. Online interventions are easily accessible and, when not using a webcam, anonymous [38‐40]. These factors can increase possibility and willingness from participants to apply for a psychosocial intervention. There is a lack of evidence-based online group interventions for adolescents with CI and for parents. Studies in this field are limited. Therefore, this study is unique in focusing on an online cognitive-behavioral group intervention for these populations.

This study has several strong points. First, participation in the intervention and the study are completely online, which eliminates logistical barriers for participants and therefore keeps drop-out rate low. Second, we include nationwide with focus on a heterogeneous group of different medical chronic diagnosis. This way, is easier to achieve a relatively large study sample, which is beneficial for the statistical power. Third strong point is that participants in the intervention group can be divided over treatment groups independent of the hospital, which benefits the feasibility of the study (it is easier to create intervention groups on different time points, this will overcome drop-out due to availability). Finally, the relatively long term follow-up period promotes stronger long-term results.

Some vulnerabilities have also to be taken into account. First, since recruitment of adolescents for health studies is challenging [67, 68], the intervention for adolescents is at risk for recruitment problems or delay. This could be a threat to the inclusion rates and the statistical power of the study. Second, due to the relatively long follow-up period it is possible that participants will seek other psychosocial support in the study period. This could bias the results. Lastly, since we include nationwide, it is impossible to identify the approached group and to determine non-response.