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NCT Number: NCT06872229

The Impact of Sensory Integration on Attention in Autism

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Messina, ME, 98164, Italy

Location status: Recruiting

Location contact

Alberto Scandurra

SUB_INVESTIGATOR

Antonino Principato

SUB_INVESTIGATOR

Chiara Marraffa

SUB_INVESTIGATOR

Flavia Marino

CONTACT

[email protected]

+393395798263

Flavia Marino

PRINCIPAL_INVESTIGATOR

Gaia Roccaforte

SUB_INVESTIGATOR

Giovanni Pioggia

SUB_INVESTIGATOR

Ileana Scarcella

SUB_INVESTIGATOR

Liliana Ruta

SUB_INVESTIGATOR

Maria Valeria Maiorana

CONTACT

Paola Chilà

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Autism
  • QI ≥ 80

Exclusion criteria

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

Treatment and study plan

Autism Spectum Conditions - intervention

Behavioral

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 - intervention

Behavioral

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.

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Pioggia

CONTACT

Ileana Scarcella

CONTACT

[email protected]

+393408322948

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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