- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872229
The Impact of Sensory Integration on Attention in Autism
March 6, 2025 updated by: Istituto per la Ricerca e l'Innovazione Biomedica
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.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ileana Scarcella
- Phone Number: +393408322948
- Email: ileana.scarcella@irib.cnr.it
Study Contact Backup
- Name: Giovanni Pioggia
Study Locations
-
-
ME
-
Messina, ME, Italy, 98164
- Recruiting
- Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
-
Contact:
- Flavia Marino
- Phone Number: +393395798263
- Email: flavia.marino@irib.cnr.it
-
Contact:
- Giovanni Pioggia
-
Contact:
- Flavia Marino
-
Contact:
- Ileana Scarcella
-
Contact:
- Paola Chilà
-
Contact:
- Chiara Marraffa
-
Contact:
- Gaia Roccaforte
-
Contact:
- Maria Valeria Maiorana
-
Contact:
- Antonino Principato
-
Contact:
- Alberto Scandurra
-
Contact:
- Liliana Ruta
-
-
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
Yes
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.
Description
Inclusion Criteria:
- Diagnosis of Autism
- QI ≥ 80
Exclusion Criteria:
- significant hearing or visual impairments
- presence of other medical disorders
- history of psychiatric diagnosis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with autism spectrum condition
Fifty ASC children with medium-high functioning, aged 4 to 12 years
|
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
Fifty Typical development children, aged 4 to 12 years
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy
Time Frame: The session needs approximately 50 minutes to complete
|
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
Time Frame: The session needs approximately 50 minutes to complete
|
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
Time Frame: The heart rate variability will be measured throughout the session (approximately 50 minutes)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Time Frame: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes
|
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
|
The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes
|
|
The Sensory Profile 2
Time Frame: The evaluation session will be scheduled pre-intervention. The test needs approximately 5-15 minutes
|
The Sensory Profile 2 is a standardized battery of self-administered caregiver questionnaires documenting the sensory processing patterns of children from birth to 14.11 years of age
|
The evaluation session will be scheduled pre-intervention. The test needs approximately 5-15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Flavia Marino, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
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 (Actual)
March 1, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNR-IRIB-PRO-2025-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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