Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale

This study, based on preliminary experimental results, literature review, and expert consultations, developed the Attentional Rating Scale (ARS). The aim was to rapidly assess participants' attention and potential influencing factors. The research focused on the scale's reliability and validity among healthy adults. Additionally, the Attention Network Test (ANT) served as the gold standard for evaluating attention. The study attempted to identify correlations between various dimensions of attention and the three attentional networks.

Study Overview

• Status: Recruiting
• Conditions: Depression; Healthy; Insomnia; Attention Disturbances
• Intervention / Treatment: Diagnostic test: rating

Detailed Description

1. To adiministrate 60 healthy subjects to evaluate internal consistency reliability.
2. To choose 20 cases for ARS retesting 7 days after the first ARS evaluation.
3. To evaluate the split half reliability through the Spearman Brown coefficient.
4. To apply principal component analysis for structural validity analysis.
5. Using the Attention Network Test (ANT) and Toronto Hospital Alertness Test (THE) as gold standards, the Pearson correlation coefficient was used for criterion validity analysis.
6. To administrate 60 patients with MDD, ADHD and insomnia disorder testing the discrimination validity of ARS.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Xinyang Zhang, master; Phone Number: +8610-62723770; Email: zhangxinyang2022@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Sixth Hospital
      • Contact: Xueqin Wang, MD; Phone Number: +8610-82077885; Email: wangxueqin@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Sixty cases of patients diagnosed with Major Depressive Disorder (MDD), ADHD and insomnia disorder separately are recruited from outpatient clinics and hospital wards. Additionally, sixty healthy individuals are recruited from the community as control subjects.

Description

Inclusion Criteria:

1. Major Depressive Disorder (MDD) or attention deficit hyperactivity disorder (ADHD) diagnosed according to DSM-5, or Chronic Insomnia Disorder diagnosed according to ICSD-3
2. Ages between 18 and 60 years old
3. Right-handed
4. Educational level ≥5 years or IQ ≥90, capable of understanding and reading Chinese.

Exclusion Criteria:

1. Currently diagnosed with any other DSM-5 mental disorders (according to MINI 7.0) or ICSD-3 sleep-wake disorders, apart from MDD, ADHD or insomnia disorder
2. Currently and past history of neurological disorders and physical illnesses with subjectives
3. Consumed alcohol in the week preceding the enrollment
4. Using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode
5. Undergoing any physical treatments such as ECT, neuromodulation therapy or Traditional Chinese Medicine treatment in the past 6 months
6. Refused to sign the informed consent form

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Major Depressive Disorder; Patients meeting the diagnostic criteria for Major Depressive Disorder (MDD) according to DSM-5.	Diagnostic test: rating; rating scales, test ANT
Chronic Insomnia Disorder; Patients meeting the diagnostic criteria for Chronic Insomnia Disorder according to ICSD-3.	Diagnostic test: rating; rating scales, test ANT
Health Control; Healthy population.	Diagnostic test: rating; rating scales, test ANT
Attention Deficit and hyperactivity Disorder; Patients meeting the diagnostic criteria for Attention Deficit and hyperactivity Disorder (ADHD) according to DSM-5.	Diagnostic test: rating; rating scales, test ANT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developing Attention Rating Scale（ARS）	The Attention Assessment Scale is developing as a tool to assess attention ability designed for self-rating scale. Its purpose is to swiftly evaluate the attention levels of adults. There are 30 items in ARS. The minimum value is 1 and maximum value is 5, and the higher scores mean a better outcome for attention ability.	3 months
Reliability and Validity of the Attention Assessment Scale.	Reliability; Cronbach α of ARS should be above 0.8 that means good reliability.; The intra group correlation value for retesting reliability should be above 0.8 that means good retesting reliability. Validity; The split half reliability measured and factor analysis to test constuctive validity of ARS.; The correlation coefficient r with ANT and the correlation coefficient r with THAT should be statistic significant, that means good validity of attention ability for Attention Assessment Scale.	2 years

Collaborators and Investigators

• Sponsor: Peking University Sixth Hospital
• Investigators: Principal Investigator: Xueqin Wang, doctor, Peking University Sixth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2022-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No