Clinical trial NCT06592911: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Learning Disorder, Specific
Learning Disability
Specific Learning Disorder, With Impairment in Reading
Dyslexia
Lead sponsor: Poppins
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2024-09-19
Enrollment: 306
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric randomized non-inferiority study
Primary purpose: TREATMENT

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 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.

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 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.

In the experimental group, patients will have access to training with Poppins Clinical for 5 sessions per week, each session lasting approximately 20 minutes.

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

Primary outcomes:
measure: Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary safety objective
timeFrame: 12 weeks
measure: Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)
timeFrame: 12 weeks
measure: Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)
timeFrame: 12 weeks
measure: Secondary objective 3: description and evaluation of the coast associated to children's treatment
timeFrame: 12 weeks
measure: Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: Secondary outcome 6: evaluate the effect of adding Poppins Clinical on meta-phonological skills between the two groups (EXPE/CONT) (non-inferiority)
timeFrame: 12 weeks
measure: Secondary objective 7: Evaluate the effect of adding Poppins Clinical on text comprehension (non-inferiority)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière, Paris, Paris 75013
city: Poitiers
country: France
facility: Hôpital Henri Laborit Poitiers, 86000
Study officials:
References: