AutismNCT07531914
Five Digits Test - Validation of a Neuropsychological Test of Inhibition for Patients With Neuropsychiatric Conditions
An observational study of Autism and ADHD, run by Umeå University at 1 site in Sweden.
Trial summary
Neuropsychiatric conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are characterized by specific deficits in cognitive functions. Thus, neuropsychological assessment is a critical part of the diagnostic process for these conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Five Digits Test
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients referred to neuropsychiatric examination, ADHD and/or autism at the Psychiatric Clinic at Umeå University Hospital will be offered to participate in the study. A comparison group of healthy volunteers will be recruited using advertising.
Who may be able to join
- age 18 and above
- Diagnosed with a ADHD or Autism, alternatively under examination these diagnoses
Who cannot join
- Addiction of alcohol or other substances
- Not speaker of Swedish to such extent that cannot read or comprehend the informed consent forms
- On sedatives, such as sleep or pain medication
- Not being able to participate in a neuropsychological examination, or to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University, Umeå University Hospital
Umeå, 90637
Nils Berginström, 0730300303, nils.berginstrom@umu.se
About this study
Neuropsychiatric conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are characterized by specific deficits in cognitive functions. Thus, neuropsychological assessment is a critical part of the diagnostic process for these conditions. Inhibition is a specific function of interest during these examinations, since it is often affected in patients with ADHD and/or autism. The Five Digits Test (FDT) is a newly developed test measuring inhibition, without requirements of reading ability, and only limited requirements of language proficiency.
The aim of this study is to investigate the validity of the FDT in patients with neuropsychiatric conditions. The FDT will be validated using the following research questions:
- Is the FDT equivalent to the standard neuropsychological test of inhibition, the Color-Word Interference Test from the Delis-Kaplan Executive Function System in patients with neuropsychiatric conditions? (Convergent validity)
- Is the FDT consistent with self-assessment of inhibition and behavioral regulation in every day life using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)? (Ecological validity)
- Are there differences in validity in the first two research questions due to language background or due to reading and writing difficulties?
- Are there differences between patients with neuropsychiatric conditions and healthy controls in the performance of the FDT?
Read the detailed description
In a cross-sectional design, patients with or under examination for either ADHD or autism will be invited to participate in the project. Patients will receive both written and oral information about the project and sign informed consent before data collection begins. After this, patients will complete the BRIEF-A and answer some questions regarding demographic and health related factors. Before starting the testing session patients will be randomly assigned to perform FDT first or the CWIT first, to control for test-retest or learning effects. Healthy controls will be recruited through advertisements, otherwise the data collection procedure will be the same as for patients.
The validity of FDT will be validated against the CWIT and the BRIEF-A using Pearson and/or Spearman correlation coefficients. The strength of the correlations will be interpreted using Cohen's (1992) cutoffs of weak (0.1), medium (0.3) and strong (0.5) correlations. Additionally, multiple linear regressions will be performed to investigate and adjust for background variables. Student's t-tests and/or ANCOVAS will be used to compare differences between groups.
- Being tested
- Five Digits Test
- Keywords
- Neuropsychological Assessment, ADHD, Autism, Inhibition
- Medical subject headings
- Autistic Disorder, Attention Deficit Disorder with Hyperactivity, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five Digits TestDiagnostic test
Neuropsychological test of Inhibition
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Patients with Attention Deficit Hyperactivity Disorder (ADHD) Receives: Diagnostic Test: Five Digits Test | |
| Autism | Patients with Autism Receives: Diagnostic Test: Five Digits Test | |
| Healthy Controls | Healthy Controls Receives: Diagnostic Test: Five Digits Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convergent validity of the Five Digits Test
The results of the Five Digits Test will be validated against the test Color-Word Interference Test from Delis-Kaplan Executive Functions system. The validation will be performed by calculation of the correlation coefficient (Pearson or Spearman) between these tests. Time to completion will be used as outcome in both tests, where slower times indicate lower performance.
Measured: Baseline
Secondary outcomes (1)
Ecological validity of the Five Digits Test
The results of the Five Digits Test will be validated against self-assessment questionnaire BRIEF - Behavior Rating Inventory of Executive Function. Time to completion in each condition is the outcome of the Five Digits Test, where a slower performance indicate a lower score. Raw scores (where higher score indicate a larger degree of problems) and scaled scores (where lower score indicate a larger degree of problems) for specific scales/indexes (Inhibition; Emotional Control; Self-monitoring; Behavioral Regulation Index) are the outcomes of interest from the BRIEF. The validation will be performed by calculation of the correlation coefficient (Pearson or Spearman) between performance on the FDT and the scales of the BRIEF.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start21 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Principal investigator, Nils Berginström, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531914
- Sponsor's protocol ID
- 2025-06699-01
- Other IDs
- 2025
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: National regulations about sharing data regarding patients.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Digits Test - Validation of a Neuropsychological Test of Inhibition for Patients With Neuropsychiatric Conditions
- ClinicalTrials.gov ID
- NCT07531914
- Acronym / sponsor ID
- 2025-06699-01
- Keywords
- Neuropsychological Assessment, ADHD, Autism, Inhibition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
Neuropsychiatric conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are characterized by specific deficits in cognitive functions. Thus, neuropsychological assessment is a critical part of the diagnostic process for these conditions. Inhibition is a specific function of interest during these examinations, since it is often affected in patients with ADHD and/or autism. The Five Digits Test (FDT) is a newly developed test measuring inhibition, without requirements of reading ability, and only limited requirements of language proficiency.
The aim of this study is to investigate the validity of the FDT in patients with neuropsychiatric conditions. The FDT will be validated using the following research questions:
- Is the FDT equivalent to the standard neuropsychological test of inhibition, the Color-Word Interference Test from the Delis-Kaplan Executive Function System in patients with neuropsychiatric conditions? (Convergent validity)
- Is the FDT consistent with self-assessment of inhibition and behavioral regulation in every day life using the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)? (Ecological validity)
- Are there differences in validity in the first two research questions due to language background or due to reading and writing difficulties?
- Are there differences between patients with neuropsychiatric conditions and healthy controls in the performance of the FDT?
Detailed description
In a cross-sectional design, patients with or under examination for either ADHD or autism will be invited to participate in the project. Patients will receive both written and oral information about the project and sign informed consent before data collection begins. After this, patients will complete the BRIEF-A and answer some questions regarding demographic and health related factors. Before starting the testing session patients will be randomly assigned to perform FDT first or the CWIT first, to control for test-retest or learning effects. Healthy controls will be recruited through advertisements, otherwise the data collection procedure will be the same as for patients.
The validity of FDT will be validated against the CWIT and the BRIEF-A using Pearson and/or Spearman correlation coefficients. The strength of the correlations will be interpreted using Cohen's (1992) cutoffs of weak (0.1), medium (0.3) and strong (0.5) correlations. Additionally, multiple linear regressions will be performed to investigate and adjust for background variables. Student's t-tests and/or ANCOVAS will be used to compare differences between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Diagnostic Test: Five Digits TestPatients with Attention Deficit Hyperactivity Disorder (ADHD) |
| Autism | – | Diagnostic Test: Five Digits TestPatients with Autism |
| Healthy Controls | – | Diagnostic Test: Five Digits TestHealthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to neuropsychiatric examination, ADHD and/or autism at the Psychiatric Clinic at Umeå University Hospital will be offered to participate in the study. A comparison group of healthy volunteers will be recruited using advertising.
Key inclusion criteria (2 listed)
- age 18 and above
- Diagnosed with a ADHD or Autism, alternatively under examination these diagnoses
Key exclusion criteria (4 listed)
- Addiction of alcohol or other substances
- Not speaker of Swedish to such extent that cannot read or comprehend the informed consent forms
- On sedatives, such as sleep or pain medication
- Not being able to participate in a neuropsychological examination, or to give informed consent
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 |
|---|---|---|
| Five Digits TestNeuropsychological test of Inhibition | Diagnostic test | ADHD, Autism, Healthy Controls |
Primary outcome
Convergent validity of the Five Digits Test
Time frame: Baseline
The results of the Five Digits Test will be validated against the test Color-Word Interference Test from Delis-Kaplan Executive Functions system. The validation will be performed by calculation of the correlation coefficient (Pearson or Spearman) between these tests. Time to completion will be used as outcome in both tests, where slower times indicate lower performance.
1 secondary outcome
Ecological validity of the Five Digits Test
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. National regulations about sharing data regarding patients.
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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.
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 Autism and ADHD, run by Umeå University 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 2 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nils Berginström, PhD (+46907868864, nils.berginstrom@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergent validity of the Five Digits Test (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 15 Apr 2026.