NCT06872229

Brief Summary

The study aims to examine how the mode of presentation of visual and auditory stimuli-separate or simultaneous-affects accuracy and reaction time in visual-auditory association in participants with Autism Spectrum Condition (ASC) compared to neurotypical individuals. The study aims to evaluate whether sensory overlap (simultaneous stimuli) increases cognitive load and decreases performance, while stimulus separation (separate presentation of visual and auditory stimuli) may facilitate processing and improve performance, especially in participants with ASC. Participants will be divided into two main groups: the first consisting of individuals with ASD and the second of neurotypical individuals. Each group will be exposed to two modes of stimulus presentation: simultaneous mode, in which visual and auditory stimuli are presented at the same time, and separate mode, in which visual and auditory stimuli are presented separately with a time interval between each. Participants will be required to complete visual-auditory association tasks. In addition to assessment of reaction time and accuracy, psychophysiological parameters will be recorded to measure cognitive load and physiological reaction to stimuli. The main hypotheses are that the simultaneous presentation of visual and auditory stimuli will increase cognitive load and reduce accuracy and reaction time in individuals with ASC, while the separate mode will improve performance, especially in the group with ASC. This study could provide important insights into how stimulus presentation mode affects learning and performance in participants with ASC, suggesting that stimulus separation could be a useful strategy for optimizing sensory processing and improving learning in educational and therapeutic settings.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2025Mar 2027

Study Start

First participant enrolled

March 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

autismautism spectrum conditionutism spectrum disordersensory overloadsensory processingsensory integration

Outcome Measures

Primary Outcomes (3)

  • Accuracy

    Accuracy will be calculated for each answer. The percentage of correct answers for the 50 tests provided will be calculated

    The session needs approximately 50 minutes to complete

  • Reaction time

    The time between delivery and the response given by the child for each task will be calculated in seconds (s)

    The session needs approximately 50 minutes to complete

  • Heart rate variability

    The electrical activity of the heart will be measured with a heart rate sensor with a chest strap

    The heart rate variability will be measured throughout the session (approximately 50 minutes)

Secondary Outcomes (2)

  • Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)

    The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes

  • The Sensory Profile 2

    The evaluation session will be scheduled pre-intervention. The test needs approximately 5-15 minutes

Study Arms (2)

Children with autism spectrum condition

Fifty ASC children with medium-high functioning, aged 4 to 12 years

Behavioral: Autism Spectum Conditions - intervention

Typical development

Fifty Typical development children, aged 4 to 12 years

Behavioral: Typical Development - intervention

Interventions

Initially, participants will participate in a familiarization session in which they will see and hear all pairs of pictures and sounds without any associated task, thus ensuring adequate understanding of the stimuli. Next, each child will be tested for each predicted condition, receiving clear instructions on the task: they will have to indicate whether the picture and sound are related. The main task consists of presenting 40 pairs of image-sound stimuli. For each pair, participants must answer the question, "Does what you saw match what you heard?" using a keypad with a green key for "Yes" and a red key for "No." Each condition includes 10 trials, distributed randomly, with short breaks between them to keep participants focused.

Children with autism spectrum condition

Initially, participants will participate in a familiarization session in which they will see and hear all pairs of pictures and sounds without any associated task, thus ensuring adequate understanding of the stimuli. Next, each child will be tested for each predicted condition, receiving clear instructions on the task: they will have to indicate whether the picture and sound are related. The main task consists of presenting 40 pairs of image-sound stimuli. For each pair, participants must answer the question, "Does what you saw match what you heard?" using a keypad with a green key for "Yes" and a red key for "No." Each condition includes 10 trials, distributed randomly, with short breaks between them to keep participants focused.

Typical development

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Fifty children with Autism Spectrum Condition (ASC) and fifty typically developing (TD) children will participate in the study. The children with ASC will be recruited and tested at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina. To be included in the study the child needs to have an ASD diagnosis based on the DSM-5 criteria from a licensed clinical child neuropsychiatrist but no established intellectual disability (ID) diagnosis. The TD children will recruit through advertisements in schools located close to the Institute. Informed consent will be obtained from all subjects involved in the study.

You may qualify if:

  • Diagnosis of Autism
  • QI ≥ 80

You may not qualify if:

  • significant hearing or visual impairments
  • presence of other medical disorders
  • history of psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, ME, 98164, Italy

RECRUITING

Related Publications (4)

  • Stevenson RA, Siemann JK, Woynaroski TG, Schneider BC, Eberly HE, Camarata SM, Wallace MT. Evidence for diminished multisensory integration in autism spectrum disorders. J Autism Dev Disord. 2014 Dec;44(12):3161-7. doi: 10.1007/s10803-014-2179-6.

    PMID: 25022248BACKGROUND
  • Noel JP, De Niear MA, Stevenson R, Alais D, Wallace MT. Atypical rapid audio-visual temporal recalibration in autism spectrum disorders. Autism Res. 2017 Jan;10(1):121-129. doi: 10.1002/aur.1633. Epub 2016 May 9.

    PMID: 27156926BACKGROUND
  • Font-Alaminos M, Cornella M, Costa-Faidella J, Hervas A, Leung S, Rueda I, Escera C. Increased subcortical neural responses to repeating auditory stimulation in children with autism spectrum disorder. Biol Psychol. 2020 Jan;149:107807. doi: 10.1016/j.biopsycho.2019.107807. Epub 2019 Nov 3.

    PMID: 31693923BACKGROUND
  • Zhou HY, Yang HX, Shi LJ, Lui SSY, Cheung EFC, Chan RCK. Correlations Between Audiovisual Temporal Processing and Sensory Responsiveness in Adolescents with Autistic Traits. J Autism Dev Disord. 2021 Jul;51(7):2450-2460. doi: 10.1007/s10803-020-04724-9.

    PMID: 32978707BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Flavia Marino

    Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Pioggia

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 12, 2025

Study Start

March 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations