Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Social cognition - Emotion Recognition
研究概览
简要总结
This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
详细描述
Development of a neuro-psychosocial tele-assistance programme for groups of children and adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and intervention include social cognition, quality of life, psychological symptomatology and coping strategies. The aim of this study is to test whether this programme improves the indicators in the mentioned variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed with a neuromuscular disease by a specialist
- •Being between 7 and 16 years old
- •Having signed an informed consent form through their legal guardians prior to participation in the study
- •Having Spanish as one of their main languages
- •Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences
排除标准
- •Presence of any other diagnosis or sensory deficit that would prevent the application of the tests or hinder the correct performance of the intervention´s activities
- •Being illiterate
结局指标
主要结局
Social cognition - Emotion Recognition
时间窗: 3 months after the intervention
Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children
Social cognition - Theory of mind - Happé's Strange Stories
时间窗: 3 months after the intervention
The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.
Social cognition - Theory of mind - RMETC
时间窗: 3 months after the intervention
The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.
Social cognition - Theory of mind - NEPSY-II
时间窗: 3 months after the intervention
Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.
次要结局
- Coping strategies - EAN(3 months after the intervention)
- Psychopathology(3 months after the intervention)
- Health-related quality of life(3 months after the intervention)
- Coping strategies - ACS(3 months after the intervention)