NCT07303413

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

June 11, 2025

Last Update Submit

December 18, 2025

Conditions

Autism Spectrum Disorder

Keywords

language

Outcome Measures

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.

    12 weeks

Secondary Outcomes (12)

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

    12 weeks

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

    12 weeks

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

    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

    12 weeks

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

    12 weeks

  • +7 more secondary outcomes

Study Arms (3)

short baseline

EXPERIMENTAL

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

Behavioral: EEG recordingBehavioral: Picture recognition test

medium baseline

EXPERIMENTAL

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

Behavioral: EEG recordingBehavioral: Picture recognition test

long baseline

EXPERIMENTAL

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

Behavioral: EEG recordingBehavioral: Picture recognition test

Interventions

EEG recordingBEHAVIORAL

EEG recording while listening to natural sounds

long baselinemedium baselineshort baseline
Picture recognition testBEHAVIORAL

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.

long baselinemedium baselineshort baseline

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderLanguage

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

December 24, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12