Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy

NCT01821170 | Completed

• 1 other identifier: CHUBX 2012/16
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.

Conditions

ADHD

Keywords

ADHD; children; cognitive remediation; virtual reality

Outcome Measures

Primary Outcomes (1)

• Score at ADHD Rating Scale before and after treatment

  At the end of study (week 8 after inclusion)

Secondary Outcomes (1)

• Performance of participants in neuropsychological tests assessing executive and attentional abilities before and after treatment

  At the end of study (week 8 after inclusion)

Study Arms (3)

Cognitive remediation

EXPERIMENTAL

Device: cognitive remediation; Other: neuropsychological tests

Supportive psychotherapy

ACTIVE COMPARATOR

Behavioral: supportive psychotherapy; Other: neuropsychological tests

Methylphenidate

ACTIVE COMPARATOR

Drug: Methylphenidate; Other: neuropsychological tests

Interventions

Methylphenidate DRUG

Patient will take treatment during two months

Methylphenidate

cognitive remediation DEVICE

Patient will have 12 sessions during 6 to 8 weeks

Cognitive remediation

supportive psychotherapy BEHAVIORAL

Patients will have 12 sessions during 6 to 8 weeks

Supportive psychotherapy

neuropsychological tests OTHER

neuropsychological tests will assess attentional and executive performance

Cognitive remediation; Methylphenidate; Supportive psychotherapy

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient, male or female, aged 7 to 11 years,
• Responding to current diagnostic criteria for ADHD according to DSM IV-TR (Diagnostic and Statistical Manual of Mental Disorders),
• Presenting a total score on the ADHD-RS (ADHD Rating Scale)\> 28 (before treatment),
• Schooled in conventional class,
• Presenting a WISC (Wechsler Intelligence Scale for Children) IV total score\> 80 (done before or in follow-up),
• Registered to social security,
• Legal represent has given informed consent to participate in the study.

You may not qualify if:

• Uncorrected perceptual disorder,
• Patient treated by psychostimulant,
• Patient under supportive psychotherapy,
• Patient treated by methylphenidate,
• Subjects with a pervasive developmental disorder, psychotic disorder, characterized major depressive disorder,
• Subjects who participated in research in the last 3 months,
• Subjects suffering from: glaucoma, hyperthyroidism, thyrotoxicosis, heart diseases (high blood pressure, congestive heart failure, etc…), cerebrovascular disorders,
• Subjects with no deficit in the virtual classroom: having a total number of hit superior to 80 and a number of commissions inferior to 21.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Fondation Caisse d'Epargne: collaborator

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Stéphanie BIOULAC, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: April 1, 2013
• Primary Completion: December 17, 2015
• Study Completion: April 27, 2016
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

FR (2)