Multicentric Randomized Non-inferiority Study Examining the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit Compared With a Control Group Receiving Weekly Speech and Reading Therapy Sessions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Poppins
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.
研究概览
简要总结
Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing skills of pediatric participants with a specific learning disability with reading and/or written expression deficit.
Participants will be assigned randomly either to an experimental group that will use the medical device in combination with reduced speech and reading therapy sessions (1 session each 2 weeks) or to the control group receiving conventional standard of care, i.e. 1 speech and reading therapy sessions per week.
详细描述
The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills.
Poppins Clinical is a software as a medical device (saMD) that combines a musical and cognitive training program and a written language training program. It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders (SLD) with reading deficit. Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game.
The POPPINS-02 study thus proposes to include two patient arms:
- The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy (1 session each 2 weeks),
- The control arm having only conventional speech and reading therapy (1 session per week) during 12 weeks.
A randomization list will be generated, directing patients to the experimental or control arm, and informing parents, the patient, and the speech and reading therapist after the first pre-test. The investigator and his team will be blinded to the patient allocation group. It is therefore a single-blind study since parents, patients, and speech and reading therapists will be aware of the randomization.
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 (Investigator, Outcomes Assessor)
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 SLD with reading deficit, based on a speech-language assessment. SLD with reading deficit is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, 2022). The speech-language assessment should consist of at least three reading and/or transcription tests with a SD (standard deviation) of at least - 1.4 or a result below the 20th percentile or two reading and/or transcription tests with a SD of at least - 2 SD or a results below the 10th percentile;
- •Subject aged between 7 and 11, enrolled from CE1 to CM2;
- •Subject receiving speech and reading therapy for less than 2 years, receiving speech and reading therapy for written language for less than 2 years, with a maximum treatment frequency of one session per week, either for at least 3 months for children followed for more than 3 months, or for the duration of the treatment for children followed for less than 3 months.;
- •French mother tongue or French bilingualism at home and more than 3 years schooling in France;
- •Tablet or smartphone available at home;
- •Subject affiliated to the French National Insurance (Sécurité Sociale);
- •Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.
排除标准
- •Subject has previously used Poppins Clinical or a previous version (Mila-Learn);
- •Unstabilized chronic illness (at investigator's discretion);
- •Participants with autism spectrum disorders or documented intellectual disabilities;
- •Vision or Hearing difficulties preventing the use of the tablet or smartphone;
- •Any condition that, in the opinion of the investigator, may prevent the patient from participating in the trial
- •Participant actively participating in an interventional study that may affect results.
- •Concurrent participation of any other family member in the same clinical trial
研究组 & 干预措施
CONTROL
1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical
EXPERIMENTAL
Reduced speech and reading therapy sessions (1 session every 2 weeks) and use of the medical device Poppins Clinical
干预措施: Poppins Clinical (Device)
结局指标
主要结局
Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.
时间窗: 12 weeks
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of correctly read words.
次要结局
- Secondary safety objective(12 weeks)
- Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)(12 weeks)
- Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)(12 weeks)
- Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)(12 weeks)
- Secondary objective 5: Description and comparison of the effect of adding Poppins Clinical on the parents' quality of life between the two groups (EXPE/CONT) (non-inferiority)(12 weeks)
- Secondary outcome 6: evaluate the effect of adding Poppins Clinical on meta-phonological skills between the two groups (EXPE/CONT) (non-inferiority)(12 weeks)
- Secondary objective 7: Evaluate the effect of adding Poppins Clinical on text comprehension (non-inferiority)(12 weeks)
- Secondary objective 3: description and evaluation of the coast associated to children's treatment(12 weeks)