Artificial Intelligence digital treatment for pediatric ADHD based on neurophysiological measures: efficacy study of Sincrolab tool based on neurophysiological and neuropsychological measures

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 29

Inclusion Criteria

ADHD Group:
1. Diagnosis of ADHD of combined presentation, issued by collegiate health professional and under compliance with criteria of the Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
2. Age between 8 and 11 years under the consent of a legal guardian
3. Withdrawal of psychoactive drug 3 days prior to the assessment phases prior and after the intervention. Psychoactive drugs include: ADDERALL XR®, VYVANSE®, CONCERTA®, FOCALIN XR®, RITALIN LA®, METADATE CD, Strattera®, or other generic-type analogues approved by the Spanish or European agency of the drug
4. Do not present additional psychoactive medication
5. Do not present psychiatric comorbidities
6. Preserved reading-writing
7. Provision for compliance with all phases of the study

Healthy Volunteer Group:
1. Age between 8 and 11 years under the consent of legal guardian
2. Typical development
3. Absence of mental or neurological diagnosis
4. Absence of perceptual or motor difficulties
5. No use of psychoactive or depression drugs that in the opinion of the researcher could be a confounding factor
6. Ability to follow verbal or written instructions

Exclusion Criteria

ADHD group:
1. Begin or abandon behavioural therapies or psychoactive drugs during the three-month period comprising the training phase. Changes in the pharmacological dose should be reported to the researchers
2. Motor difficulties that make the use of the tool impossible
3. Use of psychoactive drug that in the opinion of the researcher could be a confounding factor
4. Presence or suspicion of substance abuse in the last 6 months
5. Presence of blindness or uncorrected visual acuity difficulties
6. Medication and/or concomitant therapy
7. The use of psychotropic medications is not allowed
8. The use of other drugs is not allowed except those commonly used (for example: ibuprofen, paracetamol) and medical prescription (antibiotics)
9. Do not initiate, abandon or change types of therapy or medication

Healthy volunteers:
Positive screening on EDAH’s scales

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive performance, measured through the Nepsy II neuropsychological battery, the WAIS IV battery digit test, the Corsi cube test of the WWM IV battery and the CPT III test of conners.<br>After an initial training phase in each of the subtests, the subjects will execute each of the subtests following the same order. The evaluations will be carried out under the guidance and supervision of the assigned research staff, always being a qualified professional for such purposes.<br>The execution of the tests will be carried out at an initial moment, after randomization and prior to the training phase and after the training phase.

Secondary Outcome Measures

Name	Time	Method
Measured at an initial moment, after randomization and prior to the training phase and after the training phase:<br>1. Executive function measured using the BRIEF questionnaire: Behavior Rating Inventory of Execution Function<br>2. Symptoms of ADHD measured using the EDAH questionnaire: Attention Deficit and Hyperactivity Disorder Scale<br>3. Brain connectivity measured by magnetoencephalography