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NCT Number: NCT07303413

A Rhythmic and Auditory Approach for Children With Autism Spectrum Disorders (ASD)

The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder. The program focuses on training children to reproduce the syllable rhythms of speech, and the study will evaluate the children's language skills before and after participating in the program.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 3 and 6 at the time of inclusion
  • Have received a formal medical diagnosis of ASD
  • Have the consent of the parent(s)
  • Declaration of a language delay by the parents
  • Affiliated to social security or equivalent scheme

Exclusion criteria

  • Conditions likely to interfere with the EEG and make its interpretation difficult, including severe epilepsy or cerebral malformations.
  • Treatments likely to interfere with the EEG (sedatives, psychostimulants, anxiolytics, antidepressants).
  • Known hearing impairment

Treatment and study plan

EEG recording

Behavioral

EEG recording while listening to natural sounds

Picture recognition test

Behavioral

Children will have 4 images in front of them and a sound recording will be played to tell them which image to choose. They will have to click on the one that corresponds to what was said in the sound recording.

Primary outcomes

  1. The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.

    Time frame: 12 weeks

Secondary outcomes

  1. Comparison of Neural tracking of speech via EEG measurements of brain oscillatory activity before and after a session of listening to rhythmic sound.

    Time frame: 12 weeks

  2. Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training

    Time frame: 12 weeks

  3. Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training

    Time frame: 12 weeks

  4. Comparison of theta/gamma Phase-amplitude Coupling in auditory cortical areas via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training

    Time frame: 12 weeks

  5. correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  6. correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  7. correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  8. correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  9. correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index

    Time frame: 24 weeks

  10. correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 24 weeks

  11. correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 24 weeks

  12. correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • IHU reConnect

Registry information

Official study title

Approche Rythmique et Auditive Chez Les Enfants Avec Troubles du Spectre de l'Autisme (TSA)

Acronym: THETABOOST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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