The Impact of Sensory Integration on Attention in Autism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorIstituto per la Ricerca e l'Innovazione Biomedica
About this trial
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
This trial accepts healthy volunteersQualifiers
Diagnosis of Autism
QI ≥ 80
Disqualifiers
significant hearing or visual impairments
presence of other medical disorders
history of psychiatric diagnosis
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Autism Spectum Conditions - intervention
BehavioralInitially, 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 - intervention
BehavioralInitially, 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Children with autism spectrum condition1 intervention
Group B: Typical development1 intervention
Trial outcomes
Primary outcomes
1
Accuracy
Accuracy will be calculated for each answer. The percentage of correct answers for the 50 tests provided will be calculated
Time frame
The session needs approximately 50 minutes to complete2
Reaction time
The time between delivery and the response given by the child for each task will be calculated in seconds (s)
Time frame
The session needs approximately 50 minutes to complete3
Heart rate variability
The electrical activity of the heart will be measured with a heart rate sensor with a chest strap
Time frame
The heart rate variability will be measured throughout the session (approximately 50 minutes)Secondary outcomes
1
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
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.
Time frame
The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes2
The Sensory Profile 2
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
Time frame
The evaluation session will be scheduled pre-intervention. The test needs approximately 5-15 minutesSponsors and contacts
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Source ClinicalTrials.gov