Neurodevelopmental DisordersNCT04201509
Validity of Neurocognitive Assessment Methods in Childhood ADHD
An observational study of Neurodevelopmental Disorders and Attention Deficit Hyperactivity Disorder, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Attention Deficit Hyperactivity Disorder
- How many people
- 196 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2011to 1 Nov 2019
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012, 7 to 18 years old when recrutited to the study. School children from Lund, 7 to 18 years old when recrutited to the study.
Who may be able to join
- The individuals were assessed and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012
- Non-clinical group:
- School children from Lund.
Who cannot join
- If the individual had a diagnosed intellectual disability
- If the individual required an interpreter to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years.
Read the detailed description
In spite of extensive research on children with ADHD, there is still insufficient understanding of the discriminative validity of neurocognitive tests and how test results of neurocognitive functions and ratings of emotional factors and ADHD symptoms change over time and interacts during development. The project is studying the validity of clinical assessment methods within the Swedish child and adolescent psychiatry service (CAP) related to the identification of ADHD, additional impairments, and comorbidity. The prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years will be investigated.
Specific aims: Aim I: Study how attentiveness and impulsivity in ADHD change over three years by comparing the results of psychological tests and rating scales at baseline and after three years Aim II: Study intellectual development in ADHD by comparing the results of intelligence tests at baseline and after three years- Aim III: Study how emotional factors change over three years by comparing the results of rating scales at baseline and after three years
- Keywords
- Intelligence, Anxiety, Attention, Conduct behavior, Follow-up, Children
- Medical subject headings
- Neurodevelopmental Disorders, Attention Deficit Disorder with Hyperactivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Participants in the clinical group were recruited to the project when they were assessed for and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012. The ADHD group was treated as usual in the clinic and re-assessed during 2014-2015. | |
| Non-clinical group | Participants in the non-clinical group were recruited recruited 2012 from schools in the same district and among children of the same average age as the ADHD-group 2012. The non-clinical group did not have any intervention during the follow-up time. Th non-clinical group was re-assessed during 2015. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional status assessed with the Beck Youth Inventory.
The children were assessed with the Beck youth scales at two timepoints with a time interval of 3 years. Beck Youth Inventory consist of 5 subscales, Depression, Anxiety, Anger, Disruptive behaviour, Self-concept. It is standardized into percentiles and higher scores mean worse behaviour, except for Self-concept. In Self-concept higher scores mean better behaviour.
Measured: 2011-2012 and 2014-2015
Secondary outcomes (1)
Neuropsychological status assesses with the Conners' Continuous Performance Test (CPT) II
The children were assessed with the Conners'CPT II at two timepoints with a time interval of 3 years. Conners' CPT II is a performance based test measuring reaction time, reaction time variability, omissions and comissions. Conners' CPT II is standardised into T scores; mean=50, SD=10. Higher scores mean worse results.
Measured: 2011-2012 and 2014-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jun 2011
- Primary completion1 Jan 2016
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Peik Gustafsson, Dr, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201509
- Sponsor's protocol ID
- 2012/88
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Neurocognitive Assessment Methods in Childhood ADHD
- ClinicalTrials.gov ID
- NCT04201509
- Acronym / sponsor ID
- 2012/88
- Keywords
- Intelligence, Anxiety, Attention, Conduct behavior, Follow-up, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 17 Dec 2019 (actual)
- 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.
The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years.
Detailed description
In spite of extensive research on children with ADHD, there is still insufficient understanding of the discriminative validity of neurocognitive tests and how test results of neurocognitive functions and ratings of emotional factors and ADHD symptoms change over time and interacts during development. The project is studying the validity of clinical assessment methods within the Swedish child and adolescent psychiatry service (CAP) related to the identification of ADHD, additional impairments, and comorbidity. The prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years will be investigated.
Specific aims: Aim I: Study how attentiveness and impulsivity in ADHD change over three years by comparing the results of psychological tests and rating scales at baseline and after three years Aim II: Study intellectual development in ADHD by comparing the results of intelligence tests at baseline and after three years- Aim III: Study how emotional factors change over three years by comparing the results of rating scales at baseline and after three years
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Participants in the clinical group were recruited to the project when they were assessed for and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012. The ADHD group was treated as usual in the clinic and re-assessed during 2014-2015. |
| Non-clinical group | – | –Participants in the non-clinical group were recruited recruited 2012 from schools in the same district and among children of the same average age as the ADHD-group 2012. The non-clinical group did not have any intervention during the follow-up time. Th non-clinical group was re-assessed during 2015. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012, 7 to 18 years old when recrutited to the study. School children from Lund, 7 to 18 years old when recrutited to the study.
Key inclusion criteria (3 listed)
- The individuals were assessed and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012
- School children from Lund.
Key exclusion criteria (2 listed)
- If the individual had a diagnosed intellectual disability
- If the individual required an interpreter to participate 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.
Primary outcome
Emotional status assessed with the Beck Youth Inventory.
Time frame: 2011-2012 and 2014-2015
The children were assessed with the Beck youth scales at two timepoints with a time interval of 3 years. Beck Youth Inventory consist of 5 subscales, Depression, Anxiety, Anger, Disruptive behaviour, Self-concept. It is standardized into percentiles and higher scores mean worse behaviour, except for Self-concept. In Self-concept higher scores mean better behaviour.
1 secondary outcome
Neuropsychological status assesses with the Conners' Continuous Performance Test (CPT) II
Time frame: 2011-2012 and 2014-2015
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 20 Dec 2019.
- 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.
Peik Gustafsson, Dr principal investigator
Lund University
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 Neurodevelopmental Disorders and Attention Deficit Hyperactivity Disorder, run by Region Skane at 1 site in Sweden.
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 2 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 20 Dec 2019. 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 Sweden. 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?
Emotional status assessed with the Beck Youth Inventory. (time frame: 2011-2012 and 2014-2015). 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 20 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.