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RecruitingNCT07531914Updated Apr 15, 2026

Five Digits Test - Validation of a Neuropsychological Test of Inhibition for Patients With Neuropsychiatric Conditions

An observational study in Autism and ADHD, sponsored by Umeå University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Umeå University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. 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)
  2. 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)
  3. Are there differences in validity in the first two research questions due to language background or due to reading and writing difficulties?
  4. 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.

02

Conditions studied

  • Autism
  • ADHD

Keywords

  • Neuropsychological Assessment
  • ADHD
  • Autism
  • Inhibition
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 150 is above the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • age 18 and above
  • Diagnosed with a ADHD or Autism, alternatively under examination these diagnoses

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • ADHD

    Patients with Attention Deficit Hyperactivity Disorder (ADHD)

    Diagnostic Test: Five Digits Test

  • Autism

    Patients with Autism

    Diagnostic Test: Five Digits Test

  • Healthy Controls

    Healthy Controls

    Diagnostic Test: Five Digits Test

Interventions

  • Diagnostic testFive Digits Test

    Neuropsychological test of Inhibition

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Umeå University, Umeå University Hospital
    Umeå, 90637, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — National regulations about sharing data regarding patients.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07531914
Lead sponsor
Umeå University
Collaborators
Region Västerbotten
Responsible party
Nils Berginström (Associate professor, Umeå University) — Principal investigator
First posted
Apr 15, 2026
Start date
Jan 21, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

Nils Berginström, PhD
Contact
nils.berginstrom@umu.se
+46907868864

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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