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Not Yet RecruitingNCT07326267

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Çankırı Karatekin University · Academic / Other
Sex
All
Age
6 Years – 14 Years
Healthy volunteers
Not accepted

Summary

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. The 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. Outcomes 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. This 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.

Detailed description

This project aims to develop and evaluate a School-Based Occupational Therapy Program focused on Sensory Processing and Activities of Daily Living (ADL) through a randomized controlled feasibility trial. Children with Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) frequently experience sensory processing difficulties that adversely affect school participation, behavioral regulation, and independence in ADLs. Although the effectiveness of sensory-based and ADL-focused occupational therapy interventions has been demonstrated in clinical settings, evidence regarding their standardized, high-fidelity implementation within school environments remains limited. The study will be conducted at Vali Ayhan Çevik Special Education School and will include students aged 6-14 years. Using a two-arm, parallel-group randomized controlled design, participants will be randomly allocated (1:1) to either an intervention group or a control group. The intervention group will receive once-weekly, 50-minute occupational therapy sessions over 10-12 weeks, comprising sensory preparation, task-oriented ADL practice, and generalization activities. The control group will receive family education, a written home program, and routine school observation. Outcome assessments will be conducted at baseline (T0), post-intervention (T1), and follow-up (T2; 4-6 weeks). The primary outcome measure will be the Goal Attainment Scaling (GAS) T-score, reflecting progress toward individualized, occupation-based goals. Secondary outcomes will include the Pediatric Disability Assessment Inventory (PEDI), Sensory Profile, and a Pediatric Information Form capturing demographic and clinical routine data. Feasibility indicators-such as attendance rate, data completeness, and classroom micro-protocol utilization-as well as intervention fidelity measures, including session checklists and secondary rater/video-based evaluations, will be systematically monitored. Expected outcomes include clinically meaningful improvements in GAS scores and ADL-related indicators in the intervention group, alongside enhanced sensory equipment infrastructure and the development of teacher micro-protocols to strengthen institutional capacity. This study aims to address a significant gap in the literature on school-based occupational therapy in Türkiye by providing a feasible, standardized, and replicable intervention model for special education settings.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIndividual School-Based Occupational Therapy SessionsThis 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. Each 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.
BEHAVIORALSensory Preparation Using Proprioceptive, Vestibular, and Tactile InputIThis 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. Sensory 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.
BEHAVIORALTask-Oriented Activities of Daily Living TrainingThis 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. Training 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.
BEHAVIORALGeneralization and Classroom-Based Sensory Support StrategiesThis 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. As 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.
BEHAVIORALFamily Education and Written Home ProgramThis 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. No 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.

Timeline

Start date
2026-05-04
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2026-01-08
Last updated
2026-04-09

Source: ClinicalTrials.gov record NCT07326267. Inclusion in this directory is not an endorsement.