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NCT Number: NCT07326267

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

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.

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Key information

Conditions

Intellectual Disability, Variable Autism Spectrum Disorder Autism Spectrum Disorder (ASD) Child Development Disorders, Pervasive Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Intervention 1

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.

Other names: Intervention 2

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.

Other names: Intervention 3

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.

Other names: Intervention 4

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.

Other names: Intervention 5

Primary outcomes

  1. 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

  1. Sensory Profile

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

    Sensory Profile is an assessment tool developed by occupational therapist Winnie Dunn to evaluate sensory processing characteristics in children. It was designed for use with children aged 3-10 years and assesses children's responses to sensory stimuli during daily life activities based on caregiver observations. The scale consists of 125 items and is completed by the caregiver in approximately 30-40 minutes. Each item is rated on a 5-point Likert scale-"Always," "Frequently," "Occasionally," "Seldom," and "Never"-with scores ranging from 1 (Always) to 5 (Never). Lower scores indicate more pronounced sensory processing difficulties. The scale is organized into three main sections-sensory processing, modulation, and behavioral-emotional responses-and includes 14 derived subfactors. The Turkish version has demonstrated acceptable to high internal consistency. Although the normative age range of the test is 3-10 years, its use with children up to 14 years of age has also been reported

  2. 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)

    It was developed by Haley et al. to assess functional skills and performance levels in children. Although it was originally designed for children aged 6 months to 7.5 years, it can also be used with older children who show limitations in functional performance. The scale consists of three main components-functional skills, caregiver assistance, and modifications-each covering the domains of self-care, mobility, and social function. The functional skills component evaluates the child's level of independence using a "capable/incapable" rating, while the caregiver assistance component is scored on a scale ranging from 0 (total dependence) to 5 (independence).

Other outcomes

  1. Pediatric Information Form

    Time frame: Baseline (T0)

    The Pediatric Information Form is a structured data collection tool used to comprehensively assess children's developmental, sensory, motor, language, self-care, and social skills. It systematically gathers information on the child's demographic characteristics, medical and developmental history, parental observations, therapy background, and daily living routines. In this study, the form will be used as a pre-intervention assessment to support a holistic characterization of participants' sensory processing and daily living skills profiles.

Study contacts

Contact information is provided by the study sponsor or research team.

Ceyhun Türkmen, associate professor

CONTACT

[email protected]

90 + 531 101 73 92

Feyza Şengül, Res. Asst.

CONTACT

[email protected]

90 + 5530833895

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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