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

Pasteur Institute

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: EEG recording; Behavioral: Picture recognition test

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07303413

2025-A00707-42 (Other Identifier)

2024-091_THETABOOST

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 3 patient groups

short baseline

Experimental group

Description:

First baseline of 4 weeks and a second baseline of 8 weeks

Treatment:

Behavioral: Picture recognition test

Behavioral: EEG recording

medium baseline

Experimental group

Description:

First baseline of 6 weeks and a second baseline of 6 weeks

Treatment:

Behavioral: Picture recognition test

Behavioral: EEG recording

long baseline

Experimental group

Description:

First baseline of 8 weeks and a second baseline of 4 weeks

Treatment:

Behavioral: Picture recognition test

Behavioral: EEG recording