ADHDERNTITDAHNCT02405299
Assessment of Neurocognitive Rehabilitations of Inhibition of Disorders in ADHD in Children (ERNTITDAH)
A study testing experimental groupe in people with ADHD, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- experimental groupe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- ADHD
- Being tested
- experimental groupe
- Keywords
- child, disorders inhibition, neuropsychology, rehabilitation, ADHD, assessment of neurocognitive rehabilitations in ADHD in children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | neuropsychological reeducation disorder specific of inhibition (bottom-up and top-down protocol): 24 bi-weekly sessions (30 subjects) Receives: Other: experimental groupe |
| Control Group | Placebo comparator | non-specific and general cognitive neuropsychological reeducation (comprehension, syntactic, visuospatial) : 24 bi-weekly sessions (30 subjects) Receives: Other: experimental groupe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coline Perrier, L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405299
- Sponsor's protocol ID
- HNOVillefranche
- Acronym
- ERNTITDAH
- Status last verified
- May 2024
- First submitted
- 12 Dec 2014
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Des rééducations Neuropsychologiques Des Troubles de l'Inhibition Chez l'Enfant Avec un TDAH
- ClinicalTrials.gov ID
- NCT02405299
- Acronym / sponsor ID
- ERNTITDAH / HNOVillefranche
- Conditions
- ADHD
- Keywords
- child, disorders inhibition, neuropsychology, rehabilitation, ADHD, assessment of neurocognitive rehabilitations in ADHD in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur SaôneUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: experimental groupeneuropsychological reeducation disorder specific of inhibition (bottom-up and top-down protocol): 24 bi-weekly sessions (30 subjects) |
| Control Group | Placebo comparator | Other: experimental groupenon-specific and general cognitive neuropsychological reeducation (comprehension, syntactic, visuospatial) : 24 bi-weekly sessions (30 subjects) |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupeexercices 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 | Other | Control Group, Experimental Group |
Primary outcome
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)
1 secondary outcome
scores to neuropsychological testing inhibition before and after rehabilitation in control group
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental groupe in people with ADHD, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores to neuropsychological testing inhibition before and after rehabilitation in experimental groupe (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.