Attention Deficit Hyperactivity DisorderNCT01553695
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
A study testing questionary in people with Attention Deficit Hyperactivity Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Feb 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Authorization to use the data signed social security affiliation
Who cannot join
- Patient presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\or psychiatric.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France
ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.
As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.
The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- questionary
- Keywords
- Touble, deficit, attention, hyperactivity, Touble deficit attention with hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryOther
Subjects have to fill out a booklet of questionnaires
questionaryOther
Subjects have to fill out a booklet of questionnaires
| Study group | Role | What they receive |
|---|---|---|
| general population | Active comparator | Not described Receives: Other: questionary |
| ADHD Patient | Experimental | Not described Receives: Other: questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic of ADHD using DSM-IV criteria as implemented in the DIVA
Measured: Baseline
Secondary outcomes (1)
score of rating scales (ASRS and WURS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herve CACI, PH, Principal investigator, CHU de Nice- GCS Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553695
- Sponsor's protocol ID
- 11-AOI-01
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France
- ClinicalTrials.gov ID
- NCT01553695
- Acronym / sponsor ID
- 11-AOI-01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Touble, deficit, attention, hyperactivity, Touble deficit attention with hyperactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Mar 2012 (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.
ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.
As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.
The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general population | Active comparator | Other: questionary |
| ADHD Patient | Experimental | Other: questionary |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Authorization to use the data signed social security affiliation
Key exclusion criteria (1 listed)
- Patient presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\or psychiatric.
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 |
|---|---|---|
| questionarySubjects have to fill out a booklet of questionnaires | Other | general population |
| questionarySubjects have to fill out a booklet of questionnaires | Other | ADHD Patient |
Primary outcome
Diagnostic of ADHD using DSM-IV criteria as implemented in the DIVA
Time frame: Baseline
1 secondary outcome
score of rating scales (ASRS and WURS)
Time frame: Baseline
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 29 Jul 2014.
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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.
Herve CACI, PH principal investigator
CHU de Nice- GCS Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionary in people with Attention Deficit Hyperactivity Disorder, run by Centre Hospitalier Universitaire de Nice 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 1 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 29 Jul 2014. 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. 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?
Diagnostic of ADHD using DSM-IV criteria as implemented in the DIVA (time frame: Baseline). 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 29 Jul 2014.