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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207279
• Other study ID #: 2022-056
• Status: Recruiting
• Start date: September 28, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Peking University Sixth Hospital
• Contact: Xinyang Zhang, master
• Phone: +8610-62723770
• Email: zhangxinyang2022[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Disturbances
• Depression
• Healthy
• Insomnia

Intervention

Diagnostic Test:
• rating
rating scales, test ANT

Locations

Country	Name	City	State
China	Peking University Sixth Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reliability and Validity of the Attention Assessment Scale.	Reliability; Cronbach a 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