Effect of Music and Rhythm Training Delivered Through a Serious Game on the Reading Skills of Children With a Specific Learning Disorder Impacting Reading, a Multicentric Double-blind and Placebo-controlled Study (Mila-Learn-01)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 6
- 主要终点
- Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read
研究概览
简要总结
Mila-Learn-01 is a double-blind clinical study (meaning that neither the patient nor the doctor or his/her team will know which game the child has), which enables us to see the effect of a serious game on the child's reading skills.
The patients who will participate in this research will receive, at random, one of the two serious study games, the experimental game (Mila-Learn) or the placebo game (Mila-Placebo). The tasks designed in the placebo game mirror those of Mila-Learn.
Each game comprises eight tasks to be completed on a touchscreen tablet. Each session lasts 25 minutes (±20%); five training sessions lasting 25 minutes are planned per week for eight weeks.
详细描述
The study consists of a randomised, double-blind clinical trial with a control group to evaluate the impact of the Mila-Learn game on children's skills. In order to maintain the blinding of the patient and his/her family, the study will be presented to them as evaluating the effect of serious games on a child's learning without explaining that the study is specifically interested in the Mila-Learn game, music and rhythm.
Each child included in the study will be randomised:
- either to the experimental group (EXPE Group) and in this case will receive the Mila-Learn game
- or to the control group (CONT Group) and will receive the Mila-Placebo game.
A randomisation list will be edited by the statistician. It will allow us to know whether the patient will be in the experimental arm or the control arm when sending out the tablets, depending on the chronological order of the inclusions, so that we can send the corresponding tablet to the patient.
In each group, the children will follow the same training protocol consisting of five training sessions per week on the game corresponding to their group. Each game comprises 8 tasks to be completed on a touchscreen tablet. Each session lasts 25 minutes (±20%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
In order to maintain the blinding of the patient and his/her family, the study will be presented to them as evaluating the effect of serious games on a child's learning without explaining that the study is specifically interested in the Mila-Learn game, music and rhythm.
Evaluations will be carried out in a double-blind manner. The evaluators will not know to which group the children belong.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Specific Learning Disorder with Impairment in Reading through speech therapy testing and confirmed by a doctor. Specific Learning Disorder with Impairment in Reading is defined in the diagnostic and statistical manual of mental disorders (DSM-5).
- •Patient 7-11 years old, schooled from the second year of primary school (CE1) to the last year of primary school (CM2).
- •Native Speaker of French OR French bilingualism at home AND Child schooled in France for more than 3 years
- •Person affiliated with a social security scheme.
- •Participant's agreement to participate and the agreement of the holders of parental authority and commitment to follow the protocol.
排除标准
- •Patient undergoing or having undergone speech therapy or psychomotor therapy during the 12 months before the start of the study.
- •Patient who has previously used Mila-Learn.
- •Uncontrolled, chronic illness, at the investigator's discretion.
- •Participation in another interventional study that could impact the analysis of the study.
结局指标
主要结局
Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read
时间窗: 8 weeks after the start of training (T2)
Absolute change in the number of pseudo-words correctly read by the children in the pseudo-word reading test, EVALEO 6-15, by Launay, Maeder, Roustit and Touzin, 2018.
次要结局
- Evaluation of self-esteem measured by the Rosenberg Self-Esteem scale ; using a 4-point scale format ranging from strongly agree to strongly disagree(8 weeks after the start of training (T2))
- Evaluation of speed and accuracy skills by the percentage of words correctly read in two minutes(8 weeks after the start of training (T2))
- Evaluation of phonological skills measured by the Battery of Analytical Test on Written Language (BALE) initial or final phoneme deletion test(8 weeks after the start of training (T2))
- Evaluation of grapheme conversion skills in terms of speed and accuracy measured by two pseudo-word transcription tests(8 weeks after the start of training (T2))
- Safety criteria(During the training phase, up to 8 weeks)
- Evaluation of the reading skills by the children in the pseudo-word reading test, EVALEO 6-15(16 weeks after the start of training (T3))