Psychometric Validation of the Competitive Attention Test (CAT)

Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention

This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

• a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
• testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
• testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.

Study Overview

• Status: Terminated
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: experience 1 : Competitive attention test in healthy participants; Other: experience 2 : Competitive attention test in patients with ADHD with no treatment; Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69675
    • Centre de Recherche en Neurosciences de Lyon, INSERM U1028

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

healthy major participants:

• Age from 18 to 90 year-old
• Informed consent to participate in the study
• No neurological or psychiatric disorder
• No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder

healthy minor participants:

• Age from 6 to 17 year-old
• Informed consent of parents or guardians for the child's participation in the study
• No neurological or psychiatric disorder
• No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, Attention deficit disorder

ADHD minor patients:

• Age from 6 to 17 year-old
• Informed consent of parents or guardians for the child's participation in the study
• ADHD Diagnosis with or without hyperactivity
• No psychiatric history other than ADHD.
• For Experience 3: treatment in progress.

Exclusion Criteria:

healthy major participants

• Age below 18 or above 90 year-old
• unaffiliated or non-beneficiaries of the social security scheme

healthy minor participants:

• Age below 6 or above 18 year-old
• unaffiliated or non-beneficiaries of the social security scheme

ADHD minor patients:

• Age below 6 or above 18 year-old
• unaffiliated or non-beneficiaries of the social security scheme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy participants aged from 6 to 90 year-old	Other: experience 1 : Competitive attention test in healthy participants; Comparison of behavioral measures (reaction times and percentage of correct responses) obtained twice with the CAT test in healthy participants (2 to 6 weeks apart).
Experimental: patients with ADHD with no treatment; patients with ADHD aged from 6 to 90 year-old with no treatment	Other: experience 2 : Competitive attention test in patients with ADHD with no treatment; Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.
Experimental: patients with ADHD with treatment; patients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate)	Other: experience 2 : Competitive attention test in patients with ADHD with no treatment; Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.; Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment; Behavioral (reaction times and percentage of correct responses) and EEG measures obtained with the CAT test in patients with ADHD before and after psychostimulant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction times in healthy subjects and patients with ADHD.	Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of correct responses in healthy subjects and patients with ADHD.	Percentage of correct responses obtained with the CAT test in healthy participants and in patients with ADHD.	6 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): March 20, 2021
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder; distraction; attention; psychometric test; neuropsychological test validating procedure; psychostimulant
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 69HCL18_0376; 2018-A02597-48 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No