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

NCT07326267 | Not Yet Recruiting

• 1 other identifier: 2529c9d3ba6d4dce
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intellectual Disability, Variable; Autism Spectrum Disorder (ASD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scaling

  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.

  Baseline (T0), post-intervention at 10-12 weeks (T1), and follow-up at 4-6 weeks after the intervention (T2)

Secondary Outcomes (2)

• 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)

Other Outcomes (1)

• Pediatric Information Form

  Baseline (T0)

Study Arms (2)

School-Based OT (Sensory + ADL)

EXPERIMENTAL

Participants receive a structured, school-based individual occupational therapy program targeting sensory processing and activities of daily living.

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

Family Education and Home Program

ACTIVE COMPARATOR

Participants receive family education and a written home program without individualized occupational therapy intervention.

Behavioral: Family Education and Written Home Program

Interventions

Sensory Preparation Using Proprioceptive, Vestibular, and Tactile Input BEHAVIORAL

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 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.

Also known as: Intervention 2

School-Based OT (Sensory + ADL)

Task-Oriented Activities of Daily Living Training BEHAVIORAL

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 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.

Also known as: Intervention 3

School-Based OT (Sensory + ADL)

Generalization and Classroom-Based Sensory Support Strategies BEHAVIORAL

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 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.

Also known as: Intervention 4

School-Based OT (Sensory + ADL)

Family Education and Written Home Program BEHAVIORAL

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 direct therapeutic intervention are delivered to participants in this group during the study period. Children continue their routine school activities and standard school monitoring.

Also known as: Intervention 5

Family Education and Home Program; School-Based OT (Sensory + ADL)

Individual School-Based Occupational Therapy Sessions BEHAVIORAL

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 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.

Also known as: Intervention 1

School-Based OT (Sensory + ADL)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Related Publications (10)

• 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 BACKGROUND

• Haley SM. Pediatric Evaluation of Disability Inventory (PEDI): Development, standardization and administration manual. (No Title). 1992.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cahill S, Bazyk S. School-based occupational therapy. Case-Smith's occupational therapy for children and adolescents. 2020:627-58.

  BACKGROUND

• Jeong EH. Effects of school-based occupational therapy program for children with disabilities in elementary school in Korea: a case study. BMC Psychol. 2024 Jan 16;12(1):26. doi: 10.1186/s40359-024-01520-3.

  PMID: 38229207 BACKGROUND

MeSH Terms

Conditions

Intellectual Disability; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Ceyhun Türkmen, associate professor

  Çankırı Karatekin University, Faculty of Health Sciences, Department of Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Şengül, Res. Asst.

CONTACT

90 + 5530833895; feyzasengul@karatekin.edu.tr

Ceyhun Türkmen, associate professor

CONTACT

90 + 531 101 73 92; ceyhunturkmen@karatekin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Res. Asst.

Model Details: After baseline assessment (T0), participants will be randomly allocated in a 1:1 ratio using concealed variable block randomization to either the intervention group or the active control group. The intervention group will receive a school-based occupational therapy program consisting of once-weekly 50-minute sessions over 10-12 weeks, including sensory preparation, task-oriented activities of daily living practice, and generalization. The active control group will receive family education, a written home program, and routine school monitoring.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share