The Effectiveness of the Serious Game 'Broodles' in Improving Psychosocial Well-being of Siblings (6-9 Years Old) of Children With Visual Impairment and/or Intellectual Disability: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change in Sibling adjustment to and perceptions of their brother or sister's disability
研究概览
简要总结
The support for siblings of children with disabilities is scarce and fragmented, even though studies have shown that these siblings can benefit from support. Although some interventions for siblings have been developed, these are costly and time-consuming and the effects have not been researched thoroughly with randomized controlled trials. This study will investigate the effectiveness of the newly developed serious game 'Broodles' in improving the quality of life and psychosocial well-being of healthy siblings (aged 6-9 years) of children with intellectual disability (ID) and/or visual impairment (VI). The effectiveness of the serious game will be examined in a randomized controlled trial (RCT) with a pre-test (T0), post-test (T1) and follow-up (T2). There will be two groups, namely an experimental group playing the serious game and a waitlist control group. Quantitative and qualitative measures will be used including questionnaires, drawings and open-ended questions. Both the sibling and one parent will complete the assessments.
The serious game, named 'Broodles', is a psychological intervention that addresses how to handle thoughts and emotions concerning several important issues in the lives of siblings. The game has 8 levels that take approximately 20 minutes to play. In addition to the serious game, children make offline worksheets and parents receive tips and information on how to support their child. The primary study parameters are quality of life and sibling adjustment to and perceptions of the disability of the brother or sister. Secondary study parameters are different aspects of psychosocial well-being, including self-esteem, experienced social support, sibling relationship, coping skills, parent-child relationship, and social validity. It is expected that the participants in the experimental conditions will benefit from playing the game, namely their quality of life and psychosocial well-being is expected to improve.
详细描述
A detailed description can be found in the published protocol in Trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators will be masked at pre-test assessment only
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a brother or sister with (strongly suspected) visual impairment and/or intellectual disability (0-17;11years old), with possibly other comorbid disabilities, disorders or illnesses.
- •The brother or sister with a disability lives in the same house (at least part of the time)
- •Living in the Netherlands or Flanders (Dutch speaking part of Belgium)
排除标准
- •Having a disability, impairment or severe illness
- •Brother or sister with VI and/or ID lives in a residential care facility on a full-time basis
- •One or both parents have a disability, impairment or severe illness
- •Not speaking the Dutch language
- •No written consent from the participant and/or their legal representative
- •Another sibling in the household is already included in the study. Only one sibling per household can participate in the study. The parents will decide which sibling will participate.
结局指标
主要结局
Change in Sibling adjustment to and perceptions of their brother or sister's disability
时间窗: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
Sibling adjustment to and perceptions of their brother or sister's disability is measured with both a child-report and parent-report version of the Sibling Perception Questionnaire (SPQ) - Negative Adjustment Scale. The total score on this scale has a minimum of 18 and a maximum of 72, with a higher score indicating more negative adjustment to the disability of the brother or sister. The change in score over time on this outcome is measured, with a decreased score indicating improved adjustment.
Change in quality of life as assessed by the Psychosocial Health Summary Score of the Pediatric Quality of Life Inventory (PedsQL 4.0) - Acute Version -
时间窗: pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14)
The quality of life of the participating sibling is measured with both a child-report and parent-report version of the questionnaire Pediatric Quality of Life Inventory (PedsQL 4.0) - Acute Version - Psychosocial Health Summary Score. The total score on this scale has a minimum of 0 and a maximum of 60, with a higher score indicating more problems, and thus lower quality of life. The change in score over time on this outcome is measured, with a decreased score indicating improved quality of life.
次要结局
- Change in sibling relationship (child-report)(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Change in Self-esteem(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Change in Perceived social support(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Change in parent-child relationship(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Social validity of the intervention(post-test (T1, week 6; only group 1))
- Subjective evaluation of the intervention(post-test (T1, week 6; only group 1))
- Change in Sibling adjustment to their brother or sister's disability(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Change in sibling relationship (parent-report)(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
- Change in coping skills(pre-test (T0, week 1), post-test (T1, week 6), follow-up (T2, week 12-14))
研究者
prof. dr. Paula S. Sterkenburg
Endowed professor
VU University of Amsterdam