Status:
ACTIVE_NOT_RECRUITING
Examining the Effect of a Digital MD for Cognitive and Musical Training + Reduced Conventional SOC on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit vs a Control Group Receiving Conventional SOC.
Lead Sponsor:
Poppins
Collaborating Sponsors:
Lindus Health
Conditions:
Learning Disorder, Specific
Learning Disability
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT06592911
Start Date
December 20 2024
End Date
January 1 2026
Last Update
September 22 2025
Active Locations (2)
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1
Hôpital Pitié-Salpêtrière, Paris, Paris 75013
Paris, France, 75013
2
Hôpital Henri Laborit Poitiers, 86000
Poitiers, France, 86000