A comparative study on the efficacy of Acceptance and Commitment Therapy(ACT) and Risperidone in treatment of children with Obsessive-Compulsive Disorder

To compare the effectiveness of Acceptance and Commitment Therapy (ACT) with Risperidone monotherapy in reducing symptom severity in children diagnosed with obsessive-compulsive disorder (OCD).

A randomized, parallel-group clinical trial with a sample size of 25 children, designed to compare the effectiveness of ACT versus risperidone in treating pediatric OCD. Participants are randomized into two intervention arms with concealed allocation. This is a single-center study with outcome assessment conducted by evaluators over a 12-week period.

The trial is conducted at the Clinical Research Unit of Kargarnejad Psychiatric Hospital, Kashan University of Medical Sciences. Participants attend weekly sessions for therapy or medication monitoring. ََAsessors are aware of group allocation. Also participants and therapists are aware of the interventions.

Inclusion Criteria: Children aged 7 to 12 years. Diagnosed with obsessive-compulsive disorder (OCD) based on DSM-V criteria. Y-BOCS score of 16 or higher. Ability to participate in weekly sessions and assessments over a 12-week period. Exclusion Criteria: Presence of psychotic disorders or bipolar disorder. Severe physical illness Concurrent psychiatric therapy or medication for OCD. Diagnosis of intellectual disability, autism spectrum disorder, or ADHD.

Group 1: Risperidone Monotherapy Group 2: Acceptance and Commitment Therapy (ACT)

Primary Outcome: Reduction in total Y-BOCS score to assess OCD symptom severity at weeks 0, 2, 4, 8, and 12. Secondary Outcomes: Change in Y-BOCS score based on illness duration, age, and gender. Reduction in compulsive behaviors and distress per Y-BOCS subscales.

Sampling method is randomly selected by permuted block randomized method with 4 blocks. Based on the table of random numbers, four samples of one of the blocks with the sequence AABB, BBAA, BAAB, BABA are selected. The letter A means assigning the individual to the ACT group and the letter B means assigning the individual to the risperidone group.

Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Risperidone in Children with Obsessive-Compulsive Disorder Referred from Psychiatric Clinics in Kashan Details on Data to be Shared: For individual participant data (IPD) sharing, the following deidentified data sets are available: Primary Outcome Data: Complete deidentified IPD related to the primary outcome, specifically Y-BOCS scores at each timepoint (weeks 0, 2, 4, 8, and 12). Secondary Outcome Data: Deidentified data on secondary outcomes, including Y-BOCS scores categorized by illness duration, age group, gender, and other specific obsessive-compulsive dimensions. Participant Demographics and Baseline Characteristics: Deidentified data including age, gender, illness duration, and baseline Y-BOCS scores. If additional details or data specifications are needed, please let me know.

The deidentified IPD and supporting documents will become available 6 months after the publication of the summary results. Access to the data will remain open for a period of 5 years following the initial availability date. Start Date: 6 months post-publication of summary data. End Date: 5 years from the start date of availability. After this period, requests for data access will be considered on a case-by-case basis, with priority given to research that significantly contributes to the field.

Deidentified individual participant data (IPD) and additional supporting information/documents will be available to individuals affiliated with academic institutions, healthcare organizations, and research institutions**. Access to the data will be limited to those conducting research in related fields, with a preference for studies aimed at improving mental health treatment, particularly in pediatric populations with obsessive-compulsive disorder (OCD). Requests from individuals affiliated with for-profit businesses or commercial entities will be evaluated on a case-by-case basis, focusing on the research objectives and potential contributions to advancing OCD treatment methodologies.

Deidentified IPD and supporting documents will be shared under the following access criteria: Types of Analysis: Access will be granted primarily for analyses focused on enhancing understanding or treatment of pediatric obsessive-compulsive disorder (OCD), particularly studies exploring therapy efficacy, treatment mechanisms, or longitudinal symptom tracking. Additional analyses contributing to related mental health fields may also be considered. Request Mechanism: Interested researchers should submit a formal request, detailing their research objectives, proposed analyses, and data handling practices to ensure compliance with data privacy standards. Review and Approval Process: All requests will be reviewed by an ethics and data access committee, composed of academic and clinical professionals in psychiatry and biostatistics. Approval criteria include relevance to OCD research, methodological rigor, data privacy adherence, and potential for advancing the field of pediatric mental health. Only requests meeting these standards will receive data access permissions.

Applicants seeking access to the deidentified IPD and supporting documents should contact the Clinical Research Development Unit at Kashan University of Medical Sciences. The preferred communication method is email. Below are the contact details: Email: research.unit@kaums.ac.ir Postal Address: Kargarnejad Educational and Medical Center, End of Parastar Boulevard, Qotb Ravandi Highway, Kashan, Iran Telephone: +98 31 5558 9213Contact Person: Dr. Fatemeh Assarian

To obtain access to the requested deidentified IPD and supporting documents, the following steps must be completed: Submission of Request: The applicant submits a detailed request by email to the Clinical Research Development Unit, including a summary of the research proposal, data requirements, and intended analyses. Estimated Time: 1-2 business days for submission. Initial Review: Upon receipt, an initial review will be conducted by the data access coordinator to verify completeness and relevance to the study’s criteria. Estimated Time: 3-5 business days. Ethics and Scientific Review: The request is forwarded to the ethics and scientific review committee, which evaluates the proposed research for ethical compliance, relevance to OCD research, and data privacy protection. Estimated Time: 2-3 weeks. Approval Notification: The applicant receives a notification regarding the approval or denial of the request. If approved, additional documentation, such as a data use agreement, may be required. Estimated Time: 2-3 business days after committee review. Data Access Setup: Following approval, data access is arranged through secure means, such as encrypted file sharing or on-site access as applicable. Estimated Time: 3-5 business days. Total Estimated Time: Approximately 4-6 weeks from initial request submission to data access setup, depending on the specifics of the review process and data handling requirements. Applicants are encouraged to account for this timeline when planning their research projects.