NCT02405299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.2 years

First QC Date

December 12, 2014

Last Update Submit

May 15, 2024

Conditions

Keywords

childdisorders inhibitionneuropsychologyrehabilitationADHDassessment of neurocognitive rehabilitations in ADHD in children

Outcome Measures

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)

    5 months

Secondary Outcomes (1)

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

    5 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: experimental groupe

Control Group

PLACEBO COMPARATOR

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

Other: experimental groupe

Interventions

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

Control GroupExperimental Group

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seguin

Villefranche-sur-Saône, Rhone, 69400, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms. Seguin Charlotte, neuropsychologist psychologist

Study Record Dates

First Submitted

December 12, 2014

First Posted

April 1, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations