Development of Attention and Its Relationship With Emotions in Children and Adolescents

NCT06181747 | Completed

• 1 other identifier: E2KM011639-K12023000015
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

• Continuous Performance Test, CPT

  CPT software is one of the commonly used tools for examining attention and is a computer-assisted information processing test with objective results, independent of supervisors, and is the most widely used experimental paradigm in current research. The CPT paradigm adopted in this study is the presence of a white boxed area on a black background on the calculator screen, with white squares randomly appearing above or below the white boxed area, requiring the target stimulus to be a right mouse button press when the square appears below it.

  baseline and post (an average of 30days after baseline)

Secondary Outcomes (5)

• Swanson Nolan, and Pelham-IV rating scales, SNAP-IV

  baseline and post (an average of 30days after baseline)

• Strengths and Difficulties Questionnaire, SDQ

  baseline and post (an average of 30days after baseline)

• Behavior Rating Inventory of Executive Function, BRIEF

  baseline and post (an average of 30days after baseline)

• Anti-saccade task

  baseline and post (an average of 30days after baseline)

• Delay-saccade task

  baseline and post (an average of 30days after baseline)

Study Arms (2)

ADHD group

EXPERIMENTAL

Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly.

Device: a serious mobile device-based game prototype (Save the Muse Home)

healthy control group

EXPERIMENTAL

Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly.

Device: a serious mobile device-based game prototype (Save the Muse Home)

Interventions

a serious mobile device-based game prototype (Save the Muse Home) DEVICE

The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD.

ADHD group; healthy control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ADHD-a. Age between 6-12 years, any gender.
• ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
• ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
• HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.

You may not qualify if:

• a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
• b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
• c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
• d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
• e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
• f. Individuals with color blindness or any other condition that would prevent proper use of the software.
• g. History of or current gaming addiction.

Sponsors & Collaborators

• Institute of Psychology, Chinese Academy of Sciences: lead

Study Sites (2)

Nanjing Normal University

Nanjing, Jiangsu, China

Location

Institute of Psychology, Chinese Academy of Sciences

Beijing, China

Location

Related Publications (1)

• Luo J, Li F, Wu Y, Liu X, Zheng Q, Qi Y, Huang H, Xu G, Liu Z, He F, Zheng Y. A mobile device-based game prototype for ADHD: development and preliminary feasibility testing. Transl Psychiatry. 2024 Jun 10;14(1):251. doi: 10.1038/s41398-024-02964-2.

  PMID: 38858375 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Zhengkui Liu, Ph.D.

  Institute of Psychology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 26, 2023
• Study Start: March 1, 2023
• Primary Completion: May 5, 2023
• Study Completion: May 10, 2023
• Last Updated: March 1, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)