Development and Validation of an Artificial Intelligence-Assisted Cognitive Therapy Package for Enhancing Prefrontal Cortex Functions and Evaluating Its Effectiveness on Executive Functions and Academic Self-Regulation in Adolescents with Internet Addiction

Assess a supervised AI-supported cognitive therapy package targeting prefrontal cortex functions for effects on cognitive control, flexibility, impulsivity, reward processing, moral intelligence, and academic self-regulation in male adolescents scoring ≥50 on Young’s Internet Addiction Test; assess at baseline, post-intervention, and two-month follow-up.

Open-label, two-arm parallel randomized controlled trial; 50 participants, 25/group. Individual allocation is 1:1 using variable block sizes of 4 and 6. Sealed Envelope generates the sequence; sequentially numbered, opaque, sealed envelopes conceal allocation. Phase: not applicable.

The study involves male students at Shahid Asadi Shahed Upper Secondary School, Azarshahr. The researcher delivers 12 weekly 90-min online group sessions via Shad; parents/guardians receive a 30–45-min orientation. Controls receive usual school services. Participants and researcher are not blinded.

Fifty male students aged 15–18 at Shahid Asadi Shahed Upper Secondary School, Azarshahr, with an Internet Addiction Test score ≥50, adolescent assent, and parent/guardian consent. Severe psychiatric disorder or medication likely to affect outcomes, if identified before allocation, excludes participation.

Intervention: Twelve weekly 90-minute group cognitive therapy sessions targeting prefrontal cortex functions, with supervised AI support; plus a 30–45-minute parent/guardian orientation. Control: Usual school educational and counseling services plus a waitlist; the package is offered after two-month follow-up.

Impulsivity; Reward Responsiveness; Cognitive Control; Cognitive Flexibility; Moral Intelligence; Academic Self-Regulation

Participants will be allocated to the study groups using block randomization with variable block sizes. The unit of randomization will be the individual participant. After screening, verification of eligibility criteria, obtaining written informed consent from a parent or legal guardian and informed assent from the adolescent, and completion of baseline assessments, eligible participants will be allocated in a 1:1 ratio to the intervention and control groups. The target sample size is 50 participants, with 25 participants in each group. The random allocation sequence will be generated using the online Sealed Envelope tool, with variable block sizes of 4 and 6 participants. Before allocation begins, the generated sequence will be checked to ensure that the final list contains 50 allocations, with exactly 25 assignments to each group. If necessary, a new sequence will be generated using the same settings and a new random seed and will be checked again. The final random seed, output file, and date of sequence generation will be documented and retained. Stratified randomization will not be used. To ensure allocation concealment, the complete allocation sequence and assignment order will be held by a person independent of participant screening and enrollment. Preferably, each allocation will be placed in an opaque, sealed, sequentially numbered envelope. The envelope for each participant will be opened only after final eligibility has been confirmed, informed consent and assent have been obtained, and baseline assessments have been completed. This procedure is intended to prevent knowledge of the anticipated group assignment from influencing participant selection and enrollment.

Controlled Access to De-identified Individual Participant Data and Supporting Study Documents The study data and documentation may be shared upon an approved request. The materials may include the de-identified individual participant dataset, covering the study variables and assessment time points; the study protocol; the statistical analysis plan; blank informed consent and adolescent assent forms; the final clinical study report; the data dictionary; and analysis code or syntax, where available. Direct personal identifiers will not be shared. Before any data are transferred, indirect identifiers and the risk of re-identification will be assessed. Sensitive free-text information, private communications, and other information that could reasonably identify participants will be excluded or appropriately protected. Materials will be provided through controlled access rather than unrestricted public release.

Access will begin 12 months after completion of the study or after publication of the primary study results, whichever occurs later, and will remain available for five years. Access will be granted on a request-by-request basis, subject to eligibility review, applicable ethical approvals, and the conditions described in this data-sharing plan. No unrestricted public download will be provided.

Qualified researchers affiliated with recognized universities or research institutions, as well as competent ethics committees, regulatory authorities, or other legally authorized bodies acting within their official responsibilities, may submit a request. Applicants must demonstrate an appropriate institutional affiliation, professional competence, and a legitimate research, ethical oversight, or regulatory purpose. Access is not automatic and is subject to review and approval.

Data and documents may be used for legitimate scientific research, verification of reported findings, evidence synthesis, meta-analysis, and other secondary analyses consistent with the approved purpose and applicable ethical requirements. Each request must specify the research question, intended analyses, requested variables or documents, institutional affiliation, and data protection arrangements. Ethics committee approval or other authorization must be provided where required. Approved recipients must sign a data-use or data-sharing agreement, use the materials only for the approved purpose, protect them through appropriate security measures, refrain from attempting to identify or contact participants, and not transfer the materials to unauthorized third parties. Only the data and documents necessary and proportionate to the approved request will be released. Any sharing of individual participant data involving minors will additionally require confirmation that the proposed sharing is consistent with the applicable ethics approval and informed consent arrangements.

Requests should be addressed to Mahdi Chitsaz, PhD Candidate, Faculty of Literature and Humanities, University of Urmia, Urmia, West Azerbaijan Province, Iran. Email: mahdi.chitsaz77@gmail.com Postal Address: University of Urmia, Nazlu Campus, 11th Km, Sero Road, Urmia, West Azerbaijan Province, Iran. Applicants should provide details of the requested dataset or documents, their institutional affiliation, contact information, and a brief description of the intended purpose of use. Requests will be reviewed by the dissertation supervisors and the doctoral candidate in accordance with applicable institutional and ethical requirements.

The applicant must submit a written request specifying the required data or documents, the research question, the planned analyses, the intended purpose, the applicant's institutional affiliation, and the relevant ethics approval or authorization, where applicable. The supervisors will assess the applicant's qualifications, the legitimacy of the scientific or official purpose, the appropriateness of the scope of the request, potential confidentiality risks, and the request's consistency with the study protocol, informed consent arrangements, ethics approvals, and relevant institutional requirements. A preliminary decision will normally be communicated to the applicant within 30 working days of receipt of a complete request. Additional time may be required if consultation with the relevant ethics committee or responsible institution is necessary. If the request is approved, the recipient must sign the applicable data-use or data-sharing agreement. The approved data or documents will normally be transferred securely within 15 working days after all required documentation and agreements have been completed. A request may be declined, restricted to a subset of the requested materials, or delayed until the relevant issues are resolved if the proposed access poses a risk to confidentiality or conflicts with applicable ethical, legal, or institutional requirements. The applicant will be informed of the decision and, where appropriate, the reasons for any restrictions.

This plan is based on controlled access and does not constitute a commitment to unrestricted public disclosure of information. The Principal Investigator is willing to review reasonable and well-justified requests from qualified applicants seeking access to the study data and documentation, in accordance with the conditions described above. No direct personal identifiers or information that could reasonably lead to the identification of participants will be disclosed. Protecting the privacy of adolescent participants is a priority. Individual participant data will be shared only if such sharing is permitted by the ethics approval, informed consent arrangements, and relevant institutional requirements. If additional ethical approval or amendments to the approved informed consent arrangements are required, the necessary authorization must be obtained before the data are provided. The scope of data sharing will be determined based on the approved request, the principle of data minimization, confidentiality safeguards, and applicable ethical and legal requirements.