Assessment of Neurocognitive Rehabilitations of Inhibition of Disorders in ADHD in Children (ERNTITDAH) (ERNTITDAH)

March 31, 2015 updated by: Charlotte SEGUIN, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

Evaluation Des rééducations Neuropsychologiques Des Troubles de l'Inhibition Chez l'Enfant Avec un TDAH

This research aims to assess the cognitives rehabilitations in attention deficit disorder (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive factors for rehabilitative to improve the inhibition of disorders in ADHD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study examines the effect of neuropsychological rehabilitation on the disorder inhibtion in the child with ADHD.

Sample includes 60 subjects aged 9-13 years with disorder of inhibition evalued with neuropsychological test. Neuropsychological rehabilitation protocol was developed and evaluated.

This study use baseline and includes a control group and an experimental group. The type of cognitive procedure (up / down, or rehabilitative / metacognitive) is examined.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone
      • Villefranche Sur Saone, Rhone, France, 69400
        • Seguin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of a disorder of inhibition (assessed by neuropsychological subtests) as part of an ADHD with normal intellectual potential (ICV WISC4) in children born at term or preterm (-33SA)

Exclusion Criteria:

  • patient refusal and family to participate in the study
  • subjects with sensory disorders, psychological or unsupported, subjects carrying other cognitive disorders prevalent disorder of inhibition
  • subjects with psychostimulant treatment at inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
neuropsychological reeducation disorder specific of inhibition (bottom-up and top-down protocol): 24 bi-weekly sessions (30 subjects)
Other: experimental groupe
exercices of cognitive and neuropsychological stimulation of inhibition (paper and pencil exercises and computerized exercises) created for the experience: cognitive stimulation exercises for children in the form of cognitive and metacognitive games with rehabilitation objective disorder of inhibition
Placebo Comparator: Control Group
non-specific and general cognitive neuropsychological reeducation (comprehension, syntactic, visuospatial) : 24 bi-weekly sessions (30 subjects)
Other: experimental groupe
exercices of cognitive and neuropsychological stimulation of inhibition (paper and pencil exercises and computerized exercises) created for the experience: cognitive stimulation exercises for children in the form of cognitive and metacognitive games with rehabilitation objective disorder of inhibition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scores to neuropsychological testing inhibition before and after rehabilitation in experimental groupe
Time Frame: 5 months
comparison of the results obtained by the experimental subjects neuropsychological tests before and after rehabilitation (standard notes to NEPSY subtests, TAP, TEA-ch, Stroop test)
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scores to neuropsychological testing inhibition before and after rehabilitation in control group
Time Frame: 5 months
comparison of the results obtained by the control group subjects neuropsychological tests before and after rehabilitation (standard notes to NEPSY subtests, TAP, TEA-ch, Stroop test)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HNOVillefranche

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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