CompletedNot Applicable

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

France51 participantsStarted 2013-04-01

Plain-language 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.

Who can participate

Age range

7 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Score at ADHD Rating Scale before and after treatment

Timeframe: At the end of study (week 8 after inclusion)

Trial details

NCT IDNCT01821170

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-17

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