Emma Children's Hospital Academic Medical Center Amsterdam, Psychosocial department, Amsterdam, The Netherlands.
BMC Pediatr. 2011 Jul 14;11:65. doi: 10.1186/1471-2431-11-65.
Coping with a chronic illness (CI) challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, 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 investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect.
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.
This 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.
Current Controlled Trials ISRCTN60919570.
应对慢性疾病（CI）挑战儿童的心理社会功能和幸福感。专注于教授积极使用应对策略的认知行为干预计划可能会防止患有 CI 的儿童出现心理社会问题。让父母参与干预计划可能会增强他们在日常生活中使用所学应对策略的能力，尤其是在长期方面。本研究的主要目的是检验基于认知行为的小组干预（称为“Op Koers”）对患有 CI 的儿童及其父母的有效性。次要目的是调查为什么以及对谁而言这种干预有效，以便了解干预效果的潜在机制。
方法/设计：这是一项多中心随机对照试验。参与者是来自荷兰七家参与医院的患有慢性疾病的儿童（8 至 18 岁）及其父母。参与者被随机分配到两个干预组（儿童干预组和儿童干预与父母计划相结合组）和一个等待名单对照组。主要结果是儿童心理社会功能、幸福感和与疾病相关的儿童应对技能。次要结果是儿童生活质量、儿童一般应对技能、儿童自我认知、父母压力、亲子互动质量以及父母感知的脆弱性。结果在基线、6 周治疗后以及 6 个月和 12 个月随访期间进行评估。分析将基于意向治疗人群进行。
本研究评估了一种改善患有 CI 的儿童及其父母心理社会功能的小组干预的有效性。如果被证明有效，该干预将在临床实践中实施。讨论了研究设计的优势和局限性。
当前对照试验 ISRCTN60919570。
