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

NCT07531914 | Recruiting

• 1 other identifier: 2025-06699-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Are there differences in validity in the first two research questions due to language background or due to reading and writing difficulties?
4. 4.Are there differences between patients with neuropsychiatric conditions and healthy controls in the performance of the FDT?

Conditions

Autism; ADHD

Keywords

Neuropsychological Assessment; ADHD; Autism; Inhibition

Outcome Measures

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.

  Baseline

Secondary Outcomes (1)

• Ecological validity of the Five Digits Test

  Baseline

Study Arms (3)

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

Five Digits Test DIAGNOSTIC_TEST

Neuropsychological test of Inhibition

ADHD; Autism; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Umeå University, Umeå University Hospital

Umeå, 90637, Sweden

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Behavior

Central Study Contacts

Nils Berginström, PhD

CONTACT

+46907868864; nils.berginstrom@umu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)