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

December 18, 2025 updated by: Institut Pasteur

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: short baseline
First baseline of 4 weeks and a second baseline of 8 weeks
Behavioral: EEG recording
EEG recording while listening to natural sounds
Behavioral: Picture recognition test
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.
Experimental: medium baseline
First baseline of 6 weeks and a second baseline of 6 weeks
Behavioral: EEG recording
EEG recording while listening to natural sounds
Behavioral: Picture recognition test
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.
Experimental: long baseline
First baseline of 8 weeks and a second baseline of 4 weeks
Behavioral: EEG recording
EEG recording while listening to natural sounds
Behavioral: Picture recognition test
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks
Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Time Frame: 12 weeks
12 weeks
Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Time Frame: 12 weeks
12 weeks
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
12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.
Time Frame: 12 weeks
12 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Time Frame: 12 weeks
12 weeks
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
12 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Time Frame: 12 weeks
12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index
Time Frame: 24 weeks
24 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Time Frame: 24 weeks
24 weeks
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
24 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

IHU reConnect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-091_THETABOOST
  • 2025-A00707-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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