跳至主要内容
临床试验/NCT07531914
NCT07531914招募中不适用

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

Umeå University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Convergent validity of the Five Digits Test

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Autism

Patients with Autism

干预措施: Five Digits Test (Diagnostic Test)

Healthy Controls

Healthy Controls

干预措施: Five Digits Test (Diagnostic Test)

ADHD

Patients with Attention Deficit Hyperactivity Disorder (ADHD)

干预措施: Five Digits Test (Diagnostic Test)

结局指标

主要结局

Convergent validity of the Five Digits Test

时间窗: 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.

次要结局

  • Ecological validity of the Five Digits Test(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nils Berginström

Associate professor

Umeå University

研究点 (1)

Loading locations...

相似试验