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

NCT ID: NCT06181747

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-05-10

Brief Summary

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

Detailed Description

A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ADHD group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

healthy control group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Psychology, Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhengkui Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Psychology, Chinese Academy of Sciences

Locations

Nanjing Normal University

Nanjing, Jiangsu, China

Institute of Psychology, Chinese Academy of Sciences

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38858375 (View on PubMed)

Other Identifiers

E2KM011639-K12023000015

Identifier Type: -

Identifier Source: org_study_id