Digital training for improving reading and writing skills in children with learning disabilities

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.

This study is testing a new digital training tool to see if it can help children aged 7 to 11 with learning disabilities improve their reading and writing skills better than regular therapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 7 Years to 11 Years
• Sex: All
• Sponsor: Poppins (Industry-sponsored)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT06592911 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Poppins Clinical digital medical device, which combines cognitive and musical training, in enhancing reading and writing skills among children aged 7 to 11 diagnosed with specific learning disabilities. Participants are randomly assigned to either an experimental group that uses the device alongside reduced speech and reading therapy sessions or a control group receiving standard therapy. The study aims to determine if the digital intervention can provide comparable benefits to traditional therapy alone over a 12-week period. The trial employs a single-blind design to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are children aged 7 to 11 with a diagnosis of specific learning disorder with reading deficits who have been receiving speech and reading therapy for less than 2 years.

Not a fit: Patients who do not have a diagnosis of specific learning disorder or those who have been receiving intensive speech and reading therapy for more than 2 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve reading and writing skills in children with specific learning disabilities, offering a novel therapeutic option.

How similar studies have performed: Other studies have shown promise in using digital interventions for learning disabilities, but this specific approach with the Poppins Clinical device is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where this trial is running

Paris and 1 other locations

• Hôpital Pitié-Salpêtrière, Paris, Paris 75013 — Paris, France (Recruiting)
• Hôpital Henri Laborit Poitiers, 86000 — Poitiers, France (Recruiting)

Study contacts

• Study coordinator: Francois Vonthron

Conditions Learning Disorder, Specific; Learning Disability; Specific Learning Disorder, With Impairment in Reading; Dyslexia