School-Based Sensory Processing and Daily Living Skills-Focused Occupational Therapy Program

Official title

Development and Evaluation of a School-Based Occupational Therapy Program Focused on Sensory Processing and Activities of Daily Living: A Randomized Controlled Trial

Overview

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.

Interventions

• 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. Each session is planned and delivered by a trained occupational therapist and targets functional parti
• Behavioral 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. Sensory strategies are selected based on each child's sensory processing characteristics and observed regulation needs and may include activities such as deep
• Behavioral 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. Training emphasizes active participation, graded task demands, and repeated practice within meaningful
• Behavioral 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. As part of this component, brief classroom-based sens
• Behavioral 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. No individualized occupational therapy sessions or dire

Primary outcome measures

• Goal Attainment Scaling [Time frame: Baseline (T0), post-intervention at 10-12 weeks (T1), and follow-up at 4-6 weeks after the intervention (T2)]

Secondary outcome measures (2)

• Sensory Profile [Time frame: Baseline (T0), post-intervention at 10-12 weeks (T1), and follow-up at 4-6 weeks after the intervention (T2)]
• Pediatric Evaluation of Disability Inventory (PEDI) [Time frame: Baseline (T0), post-intervention at 10-12 weeks (T1), and follow-up at 4-6 weeks after the intervention (T2)]

Eligibility criteria

Inclusion criteria

• Regular school attendance (Anticipated ability to attend at least 70% of the planned intervention sessions during the study period);
• Written informed consent obtained from the family;
• Formal diagnosis of Autism Spectrum Disorder or Intellectual Disability, documented by an official disability report;
• Presence of observable difficulties in sensory processing and activities of daily living (ADL), verified through the student's Individualized Education Program (IEP) records;
• Ability to partially follow single-step basic instructions, as documented in the IEP records;
• Willingness of families and teachers to participate in follow-up assessments (T2 and beyond).

Exclusion criteria

• Uncontrolled epilepsy or other medical conditions that may interfere with participation or safety during sessions.
• Medical contraindications to modalities such as swinging or deep pressure or severe musculoskeletal limitations preventing participation in task-oriented ADL practice.
• Being in a period of severe acute behavioral crisis;
• Concurrent participation in occupational therapy or special education programs for ≥2 hours per week that would compromise data interpretation;
• 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;
• Inability to maintain family and/or teacher collaboration throughout the intervention period;
• Inconsistent school attendance during the intervention period (e.g., prolonged absenteeism);
• Insufficient language comprehension to engage with basic task instructions even with support.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Schaaf RC, Burke JP, Cohn E, May-Benson TA, Schoen SA, Roley SS, Lane SJ, Parham LD, Mailloux Z. State of measurement in occupational therapy using sensory integration. Am J Occup Ther. 2014 Sep-Oct;68(5):e149-53. doi: 10.5014/ajot.2014.012526. PMID 25184475
• Haley SM. Pediatric Evaluation of Disability Inventory (PEDI): Development, standardization and administration manual. (No Title). 1992.
• Mailloux Z, May-Benson TA, Summers CA, Miller LJ, Brett-Green B, Burke JP, Cohn ES, Koomar JA, Parham LD, Roley SS, Schaaf RC, Schoen SA. Goal attainment scaling as a measure of meaningful outcomes for children with sensory integration disorders. Am J Occup Ther. 2007 Mar-Apr;61(2):254-9. doi: 10.5014/ajot.61.2.254. PMID 17436848
• Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764. PMID 24185570
• Laverdure P, Beisbier S. Occupation- and Activity-Based Interventions to Improve Performance of Activities of Daily Living, Play, and Leisure for Children and Youth Ages 5 to 21: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205050p1-7501205050p24. doi: 10.5014/ajot.2021.039560. PMID 33399053
• Grandisson M, Rajotte E, Godin J, Chretien-Vincent M, Milot E, Desmarais C. Autism spectrum disorder: How can occupational therapists support schools? Can J Occup Ther. 2020 Feb;87(1):30-41. doi: 10.1177/0008417419838904. Epub 2019 Aug 11. PMID 31401850
• Ouellet B, Carreau E, Dion V, Rouat A, Tremblay E, Voisin JIA. Efficacy of Sensory Interventions on School Participation of Children With Sensory Disorders: A Systematic Review. Am J Lifestyle Med. 2018 Jul 11;15(1):75-83. doi: 10.1177/1559827618784274. eCollection 2021 Jan-Feb. PMID 33447172
• Lynch H, Moore A, O'Connor D, Boyle B. Evidence for Implementing Tiered Approaches in School-Based Occupational Therapy in Elementary Schools: A Scoping Review. Am J Occup Ther. 2023 Jan 1;77(1):7701205110. doi: 10.5014/ajot.2023.050027. PMID 36706276

Identifiers

NCT: NCT07326267 · 2529c9d3ba6d4dce

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗