ADHDNCT02942030
Differences in Attentional Profile of Children Diagnosed With ADHD Versus Children Diagnosed With Other Mental Conditions
An observational study of ADHD, run by Clalit Health Services at 1 site in Israel.
Trial summary
Attentional symptoms characterize both ADHD and other mental conditions in children. The diagnosis is based on clinical psychiatric evaluation. With the expanding knowledge regarding the neurobiological basis in ADHD the investigators have learned that attention is not a general property of the whole brain, but… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Computerized assesment battery
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Nov 2017
- Phase
- Observational
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 8-12 y/o children reffered to a psychiatric clinic for evaluation
Who may be able to join
- age 8-12
- normal intelligence quotient (IQ)
- suspected ADHD
Who cannot join
- Autism Spectrum Disorder
- blindness
- deafness
- abnormal intelligence quotient (IQ) (below 70)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Mishmar Ha'Am Clinic
Jerusalem
shlomit tsafrir, md, 972-25663638, stsafrir@clalit.org.il
About this study
Attentional symptoms characterize both ADHD and other mental conditions in children.
The diagnosis is based on clinical psychiatric evaluation.
Read more
With the expanding knowledge regarding the neurobiological basis in ADHD the investigators have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted the scientific community to the stage in which scientists can recognize different types of attention domains.
in the current study, the investigators use computerized battery to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)
Read the detailed description
Attentional symptoms characterize both ADHD and other mental conditions in children.
The diagnosis of ADHD is based on clinical psychiatric evaluation in different clinical situations the differential diagnosis is not straight forward and the clinician considers a common co-morbid conditions and common differential diagnoses.
With the expanding knowledge regarding the neurobiological basis in ADHD the scientific community have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted us to the stage in which scientists can recognize different types of attention domains. this knowledge raises the question - can the clinician use this knowledge to make the correct diagnosis based on specific attentional profile?
In the current study, the investigators use computerized battery in order to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)
- Conditions
- ADHD
- Being tested
- Computerized assesment battery
- 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.
Computerized assesment batteryOther
All participants will do a computerized assessment battery to identify specific attentional profile
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Children diagnosed with ADHD after a complete psychiatric evaluation. Receives: Other: Computerized assesment battery | |
| Non-ADHD | Children diagnosed with other mental conditions after a complete psychiatric evaluation. Receives: Other: Computerized assesment battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis - after psychiatric evaluation
Measured: november 2017
attentional computerized profile
Measured: november 2017
Secondary outcomes (1)
correlations - clinical diagnosis and attentional profile
Measured: november 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- shlomit tsafrir, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942030
- Sponsor's protocol ID
- 000816-com2
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Attentional Profile of Children Diagnosed With ADHD Versus Children Diagnosed With Other Mental Conditions
- ClinicalTrials.gov ID
- NCT02942030
- Acronym / sponsor ID
- 000816-com2
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 21 Oct 2016 (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.
Attentional symptoms characterize both ADHD and other mental conditions in children.
The diagnosis is based on clinical psychiatric evaluation.
With the expanding knowledge regarding the neurobiological basis in ADHD the investigators have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted the scientific community to the stage in which scientists can recognize different types of attention domains.
in the current study, the investigators use computerized battery to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)
Detailed description
Attentional symptoms characterize both ADHD and other mental conditions in children.
The diagnosis of ADHD is based on clinical psychiatric evaluation in different clinical situations the differential diagnosis is not straight forward and the clinician considers a common co-morbid conditions and common differential diagnoses.
With the expanding knowledge regarding the neurobiological basis in ADHD the scientific community have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted us to the stage in which scientists can recognize different types of attention domains. this knowledge raises the question - can the clinician use this knowledge to make the correct diagnosis based on specific attentional profile?
In the current study, the investigators use computerized battery in order to separate between the different attention abilities and provide specific attentional profile. in this study the investigators aim to characterize different attentional profiles in children who are diagnosed with ADHD versus children who diagnosed with other mental condition (which are common differential diagnoses of ADHD)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Other: Computerized assesment batteryChildren diagnosed with ADHD after a complete psychiatric evaluation. |
| Non-ADHD | – | Other: Computerized assesment batteryChildren diagnosed with other mental conditions after a complete psychiatric evaluation. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 8-12 y/o children reffered to a psychiatric clinic for evaluation
Key inclusion criteria (3 listed)
- age 8-12
- normal intelligence quotient (IQ)
- suspected ADHD
Key exclusion criteria (4 listed)
- Autism Spectrum Disorder
- blindness
- deafness
- abnormal intelligence quotient (IQ) (below 70)
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 |
|---|---|---|
| Computerized assesment batteryAll participants will do a computerized assessment battery to identify specific attentional profile | Other | ADHD, Non-ADHD |
Primary outcome
diagnosis - after psychiatric evaluation
Time frame: november 2017
attentional computerized profile
Time frame: november 2017
1 secondary outcome
correlations - clinical diagnosis and attentional profile
Time frame: november 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: No
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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.
shlomit tsafrir, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Clalit Health Services at 1 site in Israel.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Nov 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shlomit tsafrir, MD (972-2-5663638, stsafrir@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis - after psychiatric evaluation (time frame: november 2017). The study lists 2 primary outcomes in all. 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 Nov 2016.