Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication

Summary

This clinical trial aims to justify a protocol for designing and developing an automated decision-making system to support and enhance screening and early detection procedures for developmental speech/language difficulties in child communication. The system will utilize smart computing models, sensors, and early diagnostic speech and language deficiency indicators. The study participants will be typically and non-typically (neurodevelopmentally atypical) developing children, primarily in preschool and elementary school.

The key research questions the study seeks to address are:

1. Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study?
2. If such differences are identified, can the collected data be utilized to train an automated decision-making system capable of accurately distinguishing between typically and neurodevelopmentally atypical children based on speech and language deficiencies?

Researchers will compare typically and non-typically developed children to see if the system can incorporate multiple data points from assessment domains to create a diagnostic profile.

After the parents are informed of the study and provide written consent, they enroll in the system. Participants will be asked to wear a smartwatch and play a serious game on a tablet under the supervision of a clinician. The system will collect data from the gameplay and sensors.

Conditions

• Developmental Language Disorders
• Developmental Articulation Disorder
• Speech Disorder
• Neurodevelopmental Disorder (Diagnosis)

Interventions

DIAGNOSTIC_TEST

TD Playing the Serious Game APSOU

After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then, the child may interact with the Serious Game. Typically developed (TD) children engage under the clinician's face-to-face supervision with the serious game APSOU, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for TD children to play the whole game is estimated to be 45 minutes.

DIAGNOSTIC_TEST

Non-TD Playing Serious Game

After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then the child may interact with the serious game. Non-typically developed (non-TD) children engage under the clinician's face-to-face supervision with the serious game Apsou, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for non-TD children to play the whole game is estimated to be over an hour.

Sponsors & Collaborators

• DOTSOFT SA - GR

  collaborator UNKNOWN

• TELEGLOBAL LP - GR

  collaborator UNKNOWN

• Region of Epirus (Regional Operational Programme 'Epirus 2014-2020') - GR

  collaborator UNKNOWN

• University Hospital, Ioannina

  collaborator OTHER

• University of Ioannina

  lead OTHER

Principal Investigators

• Eugenia I Toki, PhD · University of Ioannina, Greece

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-29

Primary Completion

2023-06-30

Completion

2023-11-25

Countries

• Greece

Study Locations