Telecare-Mediated Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Social cognition - Emotion Recognition
研究概览
简要总结
This clinical trial aims to evaluate the efficacy of a telecare-mediated psychosocial and cognitive intervention for children and adolescents aged 7 to 17 with limb-girdle muscular dystrophy. This group-based intervention (comprising 5 participants) consists of 12 weekly one-hour sessions. The objective of the intervention is to improve the participants' quality of life as well as to reduce their symptomatology by targeting areas such as social cognition, emotional and personal management, cognitive restructuring, relaxation strategies, social skills, and coping strategies.
详细描述
Development and implementation of a psychosocial and cognitive tele-assistance programme for groups of children and adolescents affected by limb-girdle muscular dystrophy. 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed with limb-girdle muscular dystrophy
- •Being between 7 and 17 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 - 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.
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.
次要结局
- Health-related quality of life(3 months after the intervention)
- Health-related quality of life neuromuscular(3 months after the intervention)
- Children's Depression Inventory-Short(3 months after the intervention)
- Child Medical Fear(3 months after the intervention)
- Psychopathology(3 months after the intervention)
- Strengths and Difficulties Questionnaire(3 months after the intervention)