Development and Evaluation of a School-Based Occupational Therapy Program Focused on Sensory Processing and Activities of Daily Living: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Çankırı Karatekin University
- Enrollment
- 40
- Primary Endpoint
- Goal Attainment Scaling
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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)
It is a method developed to measure progress toward individualized goals and provides a sensitive way to monitor clinical change, particularly in populations with heterogeneous profiles and in contexts relying on subjective outcome measures. Originally developed by Kiresuk and Sherman, Goal Attainment Scaling (GAS) evaluates goal achievement using a five-point scale ranging from -2 (much less than the expected outcome) to +2 (much more than the expected outcome), with 0 representing the expected level of performance. The scale is based on measurable and behaviorally defined goals collaboratively established by the individual, family, and therapist. Each goal can be weighted according to its importance and level of difficulty (weight = importance × difficulty).Recent studies have highlighted GAS as a sensitive, clinically meaningful, and participant-centered outcome measure in pediatric rehabilitation and occupational therapy practice.
Secondary Outcomes
- Sensory Profile(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)(Baseline (T0), post-intervention at 10-12 weeks (T1), and follow-up at 4-6 weeks after the intervention (T2))
Investigators
Feyza Şengül
Res. Asst.
Çankırı Karatekin University