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CompletedNCT02405299ERNTITDAHUpdated May 16, 2024

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

An interventional study of experimental groupe in ADHD, sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône. Completed at 1 site in France. Open to participants aged 9 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ADHD

Keywords

  • child
  • disorders inhibition
  • neuropsychology
  • rehabilitation
  • ADHD
  • assessment of neurocognitive rehabilitations in ADHD in children
03

Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Experimental Group

    neuropsychological reeducation disorder specific of inhibition (bottom-up and top-down protocol): 24 bi-weekly sessions (30 subjects)

    Other: experimental groupe

  • Placebo comparator
    Control Group

    non-specific and general cognitive neuropsychological reeducation (comprehension, syntactic, visuospatial) : 24 bi-weekly sessions (30 subjects)

    Other: experimental groupe

Interventions

  • Otherexperimental 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

05

What researchers measure

Primary outcomes

  1. scores to neuropsychological testing inhibition before and after rehabilitation in experimental groupe

    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)

    Time frame: 5 months

Secondary outcomes

  1. scores to neuropsychological testing inhibition before and after rehabilitation in control group

    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)

    Time frame: 5 months

06

Study locations

1 site
  • Seguin
    Villefranche Sur Saone, Rhone 69400, France
07

Registry details

Key details

Study ID
NCT02405299
Lead sponsor
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Responsible party
Coline Perrier (Ms. Seguin Charlotte, neuropsychologist psychologist, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône) — Principal investigator
First posted
Apr 1, 2015
Start date
Oct 2013
Primary completion
Dec 2016
Completion
Dec 2016
Last update
May 16, 2024

Oversight

Data monitoring committee
No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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