Clinical trial NCT06872229: The Impact of Sensory Integration on Attention in Autism
Official title: How the Simultaneous or Delayed Presentation of Visual and Auditory Stimuli Affects Response Accuracy and Reaction Times in Participants With Autism Spectrum Condition (ASC) During an Association Task.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
autism spectrum condition
utism spectrum disorder
sensory overload
sensory processing
sensory integration
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism
* QI ≥ 80

Exclusion Criteria:

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

Primary outcomes:
measure: Accuracy
timeFrame: The session needs approximately 50 minutes to complete
measure: Reaction time
timeFrame: The session needs approximately 50 minutes to complete
measure: Heart rate variability
timeFrame: The heart rate variability will be measured throughout the session (approximately 50 minutes)
Secondary outcomes:
measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
timeFrame: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes
measure: The Sensory Profile 2
timeFrame: The evaluation session will be scheduled pre-intervention. The test needs approximately 5-15 minutes
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
state: ME
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.