Effectiveness of virtual reality as an adjunctive intervention in the treatment of Attention-Deficit/Hyperactivity Disorder: a clinical trial design

Effectiveness of virtual reality as an adjunctive intervention in the treatment of Attention-Deficit/Hyperactivity Disorder

A controlled, double-blind, randomized on 30 patient children and adolescents. A random number table will be used for randomization.

30 children and adolescents with attention-deficit/hyperactivity disorder visiting Razi Hospital in Tabriz will be enrolled in the study after providing informed consent and will be randomly assigned to either the intervention or control group. The study will be conducted in a double-blind manner, meaning that neither the outcome assessor nor the data analyst will be aware of the intervention assignment.

Inclusion criteria: ADHD diagnosis confirmed by a child and adolescent psychiatry subspecialist in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 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 legal guardians. Exclusion criteria: Disorders that fundamentally impair the ability to participate in the research or require immediate intervention that renders the use of the virtual reality headset impossible, Worsening of symptoms or the need to modify the treatment 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 virtual reality program will include exercises targeting attention, impulse control, and executive functioning.

Academic performance; Severity of attention deficit symptoms; Sustained attention; Impulsivity

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.

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.