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NCT Number: NCT07531914

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

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?

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Key information

Conditions

Autism ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Inhibition, Psychological Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University, Umeå University Hospital

Umeå, 90637, Sweden

Location status: Recruiting

Location contact

Nils Berginström

CONTACT

[email protected]

0730300303

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Five Digits Test

Diagnostic Test

Neuropsychological test of Inhibition

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ecological validity of the Five Digits Test

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nils Berginström, PhD

CONTACT

[email protected]

+46907868864

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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