NCT06234033

Brief Summary

To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 7, 2023

Last Update Submit

January 29, 2025

Conditions

Attention Deficit Hyperactivity DisorderAutism Spectrum DisorderSensory Processing Disorder

Outcome Measures

Primary Outcomes (1)

  • Sensory Profile 2

    Caregiver questionnaire to assess sensory anomalies

    8 minutes, answered within 1 month of the experimental session

Secondary Outcomes (13)

  • Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)

    1 hour 15 minutes, conducted within 1 year of the experimental session

  • Autism Quotient (AQ, child version)

    8 minutes, answered within 1 month of the experimental session

  • Childhood Behavioral Checklist (CBCL 6-16)

    15 minutes, answered within 1 month of the experimental session

  • ADHD-Ration Scale (ADHD-RS)

    15 minutes, conducted within 1 year of the experimental session

  • Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)

    1 hour, conducted within 1 year of the experimental session

  • +8 more secondary outcomes

Study Arms (3)

Children with Autism Spectrum Disorder

Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.

Behavioral: Discrimination Acuity testDiagnostic Test: Transiently Evoked Otoacoustic EmissionOther: QuestionnairesBehavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)Diagnostic Test: Clinical tests of ASDOther: Electroencephalography (EEG) with auditory or vibrotactile stimuli

Children with Attention-Deficit Hyperactivity Disorder

Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.

Behavioral: Discrimination Acuity testDiagnostic Test: Transiently Evoked Otoacoustic EmissionOther: QuestionnairesBehavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)Other: Electroencephalography (EEG) with auditory or vibrotactile stimuliDiagnostic Test: Clinical tests of ADHD

Neurotypical children

Children without a known or presumed psychiatric diagnosis.

Behavioral: Discrimination Acuity testDiagnostic Test: Transiently Evoked Otoacoustic EmissionOther: QuestionnairesBehavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli

Interventions

Discrimination Acuity testBEHAVIORAL

Estimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion.

Children with Attention-Deficit Hyperactivity DisorderChildren with Autism Spectrum DisorderNeurotypical children
Transiently Evoked Otoacoustic EmissionDIAGNOSTIC_TEST

Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.

Children with Attention-Deficit Hyperactivity DisorderChildren with Autism Spectrum DisorderNeurotypical children
QuestionnairesOTHER

Caregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2).

Children with Attention-Deficit Hyperactivity DisorderChildren with Autism Spectrum DisorderNeurotypical children
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)BEHAVIORAL

Estimates intelligence quotient

Children with Attention-Deficit Hyperactivity DisorderChildren with Autism Spectrum DisorderNeurotypical children
Clinical tests of ASDDIAGNOSTIC_TEST

Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)

Children with Autism Spectrum Disorder
Electroencephalography (EEG) with auditory or vibrotactile stimuliOTHER

Two paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks.

Children with Attention-Deficit Hyperactivity DisorderChildren with Autism Spectrum DisorderNeurotypical children
Clinical tests of ADHDDIAGNOSTIC_TEST

ADHD-Rating Scale (ADHD-RS)

Children with Attention-Deficit Hyperactivity Disorder

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population include three well-defined groups of subjects: 1. Children with a diagnosis of ASD from the local Child and Adolescent Psychiatry clinic. 2. Children with a diagnosis of ADHD from the local Child and Adolescent Psychiatry clinic. 3. Neurotypical children without any psychiatric or neurologic diagnosis.

You may qualify if:

  • Clinically diagnosed with either ADHD, ASD, or no diagnosis (typical development)
  • Between 8-15 years old

You may not qualify if:

  • Familiar history of schizophrenia and depression.
  • Epilepsy, cerebral palsy, traumatic brain injury
  • Musculoskeletal illnesses
  • Hearing or visual impairment that cannot be corrected
  • Lack of ability to cooperate
  • Parents cannot read Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science and Technology

Aalborg, North Denmark, 9260, Denmark

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAutism Spectrum Disorder

Interventions

Surveys and QuestionnairesWechsler Scales

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthIntelligence TestsAptitude TestsPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Sabata Gervasio

CONTACT

9940 8820saba@hst.aau.dk

Daniel Skak Mazhari-Jensen

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-Fellow

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 31, 2024

Study Start

November 1, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

January 31, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)