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IRCT20260822070753N1 IRCT 2026-09-17 Tabriz University of Medical Sciences Effectiveness of virtual reality in the treatment of Attention-Deficit/Hyperactivity Disorder Effectiveness of virtual reality as an adjunctive intervention in the treatment of Attention-Deficit/Hyperactivity Disorder: a clinical trial design 2026-09-23 anticipated 30 Recruiting https://irct.ir/trial/93258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After identifying eligible patients based on the inclusion and exclusion criteria, a list of eligible individuals will be prepared. If the number of eligible individuals exceeds the required sample size, each individual will be assigned a unique identification number, and the required sample will be selected from this list using a table of random numbers. For this purpose, a starting point will be selected randomly from the table, and the numbers will be read in a prespecified direction, namely [by row/by column]. Numbers outside the range of the assigned identification numbers and duplicate numbers will be excluded, and this process will continue until the required sample size has been selected. After sample selection and obtaining informed consent, participants will be allocated to the intervention and control groups using simple randomization with a 1:1 allocation ratio. In this study, the individual patient will be considered the unit of randomization, and cluster randomization will not be used; that is, each patient will be assigned independently and separately to either the intervention or control group. In addition, given the objectives of the study, stratified randomization will not be used, and no strata will be defined based on variables such as age, sex, disease severity, or other clinical characteristics. To generate the random allocation sequence, after determining the final sample size, each participant will be assigned a numerical code according to the order of entry into the study. A starting point will then be selected from the table of random numbers, and the numbers will be read in the predetermined direction. For each participant, group allocation will be determined based on the random number obtained, such that even numbers will be assigned to the intervention group and odd numbers to the control group [or vice versa]. Duplicate numbers and numbers outside the required range will be excluded during the sequence-generation process. This procedure will continue until the allocation sequence for all required participants has been completed. Therefore, the tool used to generate the random sequence in this study will be a table of random numbers; no statistical software, lottery method, or sealed envelopes will be used. The random allocation sequence will be prepared before the enrollment of patients begins and will be maintained by [a research assistant/an individual who will not be involved in participant recruitment, assessment, or intervention delivery]. After final confirmation of the eligibility criteria, obtaining informed consent, and recording each patient’s baseline information, group allocation will be performed according to the first unused code in the random allocation sequence. The researcher responsible for identifying and initially assessing the patients will not be aware of their group allocation before their enrollment in the study is finalized and will not have access to the subsequent allocation codes. Accordingly, the allocation sequence will not be predictable before the definitive enrollment of participants, thereby reducing the possibility of selection or modification of group assignments by the researcher. This procedure will be implemented to ensure allocation concealment, Blinding description: This study will implement a single-blind design where participants and outcome assessors will be blinded to group allocation, while therapists will remain unblinded due to the psychological nature of the intervention. All medical personnel and data analysts will maintain blinding regarding treatment assignments until completion of outcome assessments. N/A Attention Deficit Hyperactivity Disorder. Intervention 1: Control group: Will continue standard Psychiatric care only, with identical assessments but no additional psychological intervention during the study period. Intervention 2: Intervention group: Participants in the intervention group, comprising children and adolescents, will receive a fully immersive virtual reality intervention over an 8-week period, consisting of two 30-minute sessions per week. The intervention will be delivered using wearable, head-mounted Meta Quest devices. The virtual reality program will include exercises targeting attention, impulse control, and executive functioning. Each session will comprise interactive scenarios with progressively increasing levels of difficulty. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided.
public Shahrokh Amiri
Tabriz Razi Psychiatric Hospital, Building Number 1, Golshahr Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167846184 +98 41 5135 2308 sh_amiri1348@yahoo.com Tabriz University of Medical Sciences scientific Shahrokh Amiri
Tabriz Razi Psychiatric Hospital, Building Number 1, Golshahr Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5167846184 +98 41 5135 2308 sh_amiri1348@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) ADHD diagnosis confirmed by a child and adolescent psychiatry subspecialist in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Absence of any comorbid psychiatric disorders. No history of receiving virtual reality-based interventions during the preceding six months. Provision of written informed consent by the participants and, for participants below the legal age of consent, by their parents or legal guardians. 8 years 18 years Both Disorders that substantially impair the participant’s ability to take part in the study or require immediate clinical intervention, including serious suicidal risk, active psychotic disorders, autism spectrum disorder requiring substantial support, or sensory–motor impairments that preclude the use of a virtual reality headset. Worsening of symptoms or the need to modify the standard treatment during the study period. F90 Attention-deficit hyperactivity disorders Treatment - Other Treatment - Other Control group: Will continue standard Psychiatric care only, with identical assessments but no additional psychological intervention during the study period. Intervention group: Participants in the intervention group, comprising children and adolescents, will receive a fully immersive virtual reality intervention over an 8-week period, consisting of two 30-minute sessions per week. The intervention will be delivered using wearable, head-mounted Meta Quest devices. The virtual reality program will include exercises targeting attention, impulse control, and executive functioning. Each session will comprise interactive scenarios with progressively increasing levels of difficulty. Academic performance. Timepoint: Before the intervention began, after the final intervention session, and three months after the intervention. Method of measurement: Objective report card grades in core subjects and the parent-report questionnaire on academic performance. Severity of attention deficit symptoms. Timepoint: Before the intervention began, after the final intervention session, and three months after the intervention. Method of measurement: Conner's Parent Rating Scaled-Revised Questionnaire. Sustained attention. Timepoint: Before the intervention began, after the final intervention session, and three months after the intervention. Method of measurement: Integrated Visual and Auditory Continuous Performance Test–Second Edition. Impulsivity. Timepoint: Before the intervention began, after the final intervention session, and three months after the intervention. Method of measurement: Integrated Visual and Auditory Continuous Performance Test–Second Edition. Tabriz University of Medical Sciences Approved 2026-07-13 Ethics Committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)