[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618026":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":55,"centralContacts":60,"locations":65,"responsibleParty":70,"collaborators":65,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":65,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":65,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":104,"whyStopped":65,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":65},{"fullName":5,"class":6},"Çankırı Karatekin University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"School-Based OT (Sensory + ADL)","EXPERIMENTAL","Participants receive a structured, school-based individual occupational therapy program targeting sensory processing and activities of daily living.",[13,14,15,16,17],"Behavioral: Individual School-Based Occupational Therapy Sessions","Behavioral: Sensory Preparation Using Proprioceptive, Vestibular, and Tactile Input","Behavioral: Task-Oriented Activities of Daily Living Training","Behavioral: Generalization and Classroom-Based Sensory Support Strategies","Behavioral: Family Education and Written Home Program",{"label":19,"type":20,"description":21,"interventionNames":22},"Family Education and Home Program","ACTIVE_COMPARATOR","Participants receive family education and a written home program without individualized occupational therapy intervention.",[17],[24,31,37,43,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Individual School-Based Occupational Therapy Sessions","This intervention consists of individually delivered, school-based occupational therapy sessions conducted once weekly in 50-minute sessions over a period of 10-12 weeks. Sessions are implemented in a designated therapy space within the school environment and are guided by a predefined intervention protocol to ensure standardization while allowing individualization based on each child's needs.\n\nEach session is planned and delivered by a trained occupational therapist and targets functional participation within daily school routines. Intervention content is individualized according to the child's sensory processing profile, functional performance, and prioritized activities of daily living goals. Session fidelity is monitored using structured checklists to ensure adherence to the protocol across the intervention period.",[9],[30],"Intervention 1",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Sensory Preparation Using Proprioceptive, Vestibular, and Tactile Input","IThis intervention component involves structured sensory preparation activities implemented at the beginning of each individual occupational therapy session. Sensory preparation is designed to support arousal regulation, attention, and readiness for task engagement by providing individualized proprioceptive, vestibular, and tactile input.\n\nSensory strategies are selected based on each child's sensory processing characteristics and observed regulation needs and may include activities such as deep pressure input, controlled movement experiences, and tactile modulation tasks. The intensity, duration, and combination of sensory inputs are adjusted within a standardized framework to optimize engagement in subsequent task-oriented activities.",[9],[36],"Intervention 2",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Task-Oriented Activities of Daily Living Training","This intervention component focuses on task-oriented training targeting individualized activities of daily living relevant to the child's school and daily life contexts. Activities are selected collaboratively based on assessment findings and may include self-care and school-related daily living tasks such as hand washing, eating, dressing, organizing personal belongings, and waiting in line.\n\nTraining emphasizes active participation, graded task demands, and repeated practice within meaningful contexts. Tasks are adapted to the child's current performance level to promote skill acquisition, independence, and functional efficiency. Performance is supported through appropriate cueing, environmental modification, and adaptive strategies as needed. Progress toward individualized goals is monitored throughout the intervention period and informs ongoing task selection and grading.",[9],[42],"Intervention 3",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Generalization and Classroom-Based Sensory Support Strategies","This intervention component focuses on supporting the generalization and sustainability of gains achieved during individual occupatinal therapy sessions by embedding sensory and task-related strategies into natural school and home contexts. Structured generalization activities are implemented to facilitate the transfer of individualized activities of daily living skills from therapy sessions to classroom routines and daily life environments.\n\nAs part of this component, brief classroom-based sensory support strategies (\"sensory micro-protocols\") are introduced through teacher guidance. These strategies are designed to promote sensory regulation and participation during typical classroom activities (e.g., transitions, seated tasks, waiting periods) without disrupting routine educational flow. Teachers are provided with clear, feasible guidance on when and how to apply these strategies in response to children's sensory regulation needs.",[9],[48],"Intervention 4",{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Family Education and Written Home Program","This intervention consists of structured family education and a written home program focused on supporting children's activities of daily living within the home environment. Families receive guidance on daily living routines, environmental organization, and basic strategies to support independence and participation in everyday tasks. Educational content is provided in a standardized written format to ensure consistency across participants.\n\nNo individualized occupational therapy sessions or direct therapeutic intervention are delivered to participants in this group during the study period. Children continue their routine school activities and standard school monitoring.",[19,9],[54],"Intervention 5",[56],{"name":57,"affiliation":58,"role":59},"Ceyhun Türkmen, associate professor","Çankırı Karatekin University, Faculty of Health Sciences, Department of Occupational Therapy","PRINCIPAL_INVESTIGATOR",[61,67],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Feyza Şengül, Res. Asst.","CONTACT","90 + 5530833895",null,"feyzasengul@karatekin.edu.tr",{"name":57,"role":63,"phone":68,"phoneExt":65,"email":69},"90 + 531 101 73 92","ceyhunturkmen@karatekin.edu.tr",{"type":59,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Feyza Şengül","Res. Asst.","100618026","school-based-sensory-processing-and-daily-living-skills-focused-occupational-therapy-program-100618026",false,"NCT07326267","School-Based Sensory Processing and Daily Living Skills-Focused Occupational Therapy Program","Development and Evaluation of a School-Based Occupational Therapy Program Focused on Sensory Processing and Activities of Daily Living: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Regular school attendance (Anticipated ability to attend at least 70% of the planned intervention sessions during the study period);\n* Written informed consent obtained from the family;\n* Formal diagnosis of Autism Spectrum Disorder or Intellectual Disability, documented by an official disability report;\n* Presence of observable difficulties in sensory processing and activities of daily living (ADL), verified through the student's Individualized Education Program (IEP) records;\n* Ability to partially follow single-step basic instructions, as documented in the IEP records;\n* Willingness of families and teachers to participate in follow-up assessments (T2 and beyond).\n\nExclusion Criteria:\n\n* Uncontrolled epilepsy or other medical conditions that may interfere with participation or safety during sessions.\n* Medical contraindications to modalities such as swinging or deep pressure or severe musculoskeletal limitations preventing participation in task-oriented ADL practice.\n* Being in a period of severe acute behavioral crisis;\n* Concurrent participation in occupational therapy or special education programs for ≥2 hours per week that would compromise data interpretation;\n* Presence of severe visual or hearing impairments that would substantially limit the child's ability to perceive sensory stimuli, follow task instructions, or validly engage in assessment procedures;\n* Inability to maintain family and\u002For teacher collaboration throughout the intervention period;\n* Inconsistent school attendance during the intervention period (e.g., prolonged absenteeism);\n* Insufficient language comprehension to engage with basic task instructions even with support.","ALL","6 Years","14 Years",{"count":84,"type":85},40,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study aims to develop and evaluate a school-based occupational therapy program focused on sensory processing and activities of daily living for children with Autism Spectrum Disorder and Intellectual Disability. Sensory processing difficulties often affect school participation, behavior regulation, and independence in daily tasks. Although occupational therapy interventions have shown benefits in clinical settings, evidence for their use in schools is limited.\n\nThe trial will take place at Vali Ayhan Çevik Special Education School and will enroll students aged 6 to 14 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive weekly 50-minute occupational therapy sessions for 10 to 12 weeks, including sensory preparation, task-oriented practice, and strategies to support everyday skills. The control group will receive family education, a written home program, and routine school observation.\n\nOutcomes will be assessed at baseline, after the intervention, and at 4 to 6-week follow-up. The main outcome is change in Goal Attainment Scaling scores, which reflect progress toward individualized goals. Additional measures include functional ability, sensory processing, and demographic and clinical information. The study will also monitor feasibility and how closely the program is delivered as planned.\n\nThis research is expected to provide evidence on the feasibility and effects of a standardized occupational therapy program in a school setting and to support the use of similar approaches in educational contexts.",[91,92],"Intellectual Disability, Variable","Autism Spectrum Disorder (ASD)",[94,95,96,97,98,99,100,101,102,103],"School-Based Occupational Therapy","Sensory Processing Intervention","Activities of Daily Living (ADL)","Intellectual Disability (ID)","Randomized Controlled Trial","Feasibility Trial","Goal Attainment Scaling (GAS)","Special Education School","Independence","Sensory Integration","NOT_YET_RECRUITING","2026-04-08",{"date":107,"type":108},"2026-04-09","ACTUAL",{"date":110,"type":85},"2026-05-04",{"date":112,"type":85},"2027-03-01",{"name":5,"class":6}]