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
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.
- 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.