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

February 26, 2024 updated by: Xueqin Wang, Peking University Sixth Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Sixth Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Developing Attention Rating Scale（ARS）
Time Frame: 3 months
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.
Time Frame: 2 years

Reliability

  1. Cronbach α of ARS should be above 0.8 that means good reliability.
  2. The intra group correlation value for retesting reliability should be above 0.8 that means good retesting reliability.

Validity

  1. The split half reliability measured and factor analysis to test constuctive validity of ARS.
  2. 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Sixth Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xueqin Wang, Doctor, Peking University Sixth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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