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

Sponsor

L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône (Other)

Overall Status

Unknown status

CT.gov ID

NCT02405299

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Other: experimental groupe	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

scores to neuropsychological testing inhibition before and after rehabilitation in experimental groupe [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)

Secondary Outcome Measures

scores to neuropsychological testing inhibition before and after rehabilitation in control group [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seguin	Villefranche Sur Saone	Rhone	France	69400

Sponsors and Collaborators

L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charlotte SEGUIN, Ms. Seguin Charlotte, neuropsychologist psychologist, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

ClinicalTrials.gov Identifier:

NCT02405299

Other Study ID Numbers:

HNOVillefranche

First Posted:

Apr 1, 2015

Last Update Posted:

Apr 1, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Charlotte SEGUIN, Ms. Seguin Charlotte, neuropsychologist psychologist, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

assessment of neurocognitive rehabilitations in ADHD in children

Study Results

No Results Posted as of Apr 1, 2015