Structured Sensory-Based Occupational Therapy in Children With Autism
7 de septiembre de 2026 actualizado por: Emre DANSUK
Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study
This controlled clinical study will investigate the effects of a 12-week structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.
Forty children aged 3-9 years will be assigned to either an intervention group receiving face-to-face occupational therapy twice weekly or a control group receiving an individualized home program.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This controlled clinical study will evaluate the effects of a structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.
A total of 40 children aged 3-9 years with Level 2 autism spectrum disorder will be assigned to a structured sensory-based occupational therapy group (n=20) or a control group (n=20). The intervention group will receive 40-minute, face-to-face occupational therapy sessions twice weekly for 12 weeks. The sessions will be structured according to each child's sensory and functional needs and will be progressively adapted based on the child's clinical development. The control group will receive individualized home recommendations, which will be monitored weekly using information and visual records provided by caregivers.
Assessments will be performed at baseline and after 12 weeks. Occupational performance and satisfaction will be evaluated using the Canadian Occupational Performance Measure, sensory processing using the Dunn Sensory Profile, gross motor development using the Test of Gross Motor Development-Third Edition, and eating behaviors using the Children's Eating Behaviour Questionnaire.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Emre Dansuk, PhD
- Número de teléfono: 05377790434
- Correo electrónico: edansuk@medipol.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Burak Menek, PhD
Ubicaciones de estudio
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Beykoz
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Istanbul, Beykoz, Turquía (Türkiye), 34815
- Reclutamiento
- Emre Dansuk
-
Contacto:
- Emre Dansuk, PhD
- Número de teléfono: 05377790434
- Correo electrónico: edansuk@medipol.edu.tr
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Children aged 3-9 years
- Diagnosis of autism spectrum disorder according to DSM-5 criteria
- Level 2 autism spectrum disorder
- Residence in Istanbul
- Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- Presence of an additional neurological, psychiatric, genetic, or developmental diagnosis
- Regular medication use that may affect study outcomes
- History of epilepsy or seizures
- Inability to participate in the assessment or intervention procedures
- Participation in another structured sensory-based occupational therapy program during the study period
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Structured Sensory-Based Occupational Therapy Group
Participants in this group will receive 40-minute, face-to-face structured sensory-based occupational therapy sessions twice weekly for 12 weeks.
The intervention will be individualized according to each child's sensory and functional needs and will include tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance activities.
Session content will be progressively adapted according to the child's development.
Caregivers will also receive brief recommendations for home practice.
|
The intervention will consist of individualized sensory-based occupational therapy activities addressing tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance needs.
It will be delivered face-to-face for 40 minutes, twice weekly, over 12 weeks, and will be progressively adapted according to each child's clinical needs and development.
|
|
Comparador activo: Home Program Control Group
Participants in this group will receive individualized home-based activity recommendations using materials available in the home environment.
The home program will be implemented for 12 weeks and will be monitored weekly for approximately 10 minutes using verbal information and visual records provided by caregivers.
Participants will not receive face-to-face structured sensory-based occupational therapy during the study period.
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Caregivers will implement individualized home-based sensory and functional activity recommendations using materials available in the home environment.
The program will continue for 12 weeks and adherence will be monitored weekly through caregiver reports and visual records.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Occupational Performance
Periodo de tiempo: Baseline and Week 12
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Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure.
Higher scores will indicate better perceived occupational performance.
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Baseline and Week 12
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Change in Satisfaction with Occupational Performance
Periodo de tiempo: Baseline and Week 12
|
Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure.
Higher scores will indicate greater satisfaction.
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Baseline and Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Sensory Processing
Periodo de tiempo: Baseline and Week 12
|
Sensory processing will be assessed using the Dunn Sensory Profile.
Scale scores will be interpreted according to the instrument's standardized scoring system.
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Baseline and Week 12
|
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Change in Gross Motor Development
Periodo de tiempo: Baseline and Week 12
|
Gross motor development will be assessed using the Test of Gross Motor Development Third Edition, including locomotor and ball skills subscales.
Higher scores will indicate better gross motor performance.
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Baseline and Week 12
|
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Change in Eating Behaviors
Periodo de tiempo: Baseline and Week 12
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Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.
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Baseline and Week 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Emre DANSUK, PhD, Medipol University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de agosto de 2026
Finalización primaria (Estimado)
1 de noviembre de 2026
Finalización del estudio (Estimado)
1 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E-10840098-202.3.02-4787
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes.
Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.
Marco de tiempo para compartir IPD
Beginning immediately after publication and available for five years.
Criterios de acceso compartido de IPD
Data will be made available to qualified researchers who submit a methodologically sound research proposal.
Requests will be reviewed by the corresponding author and will require institutional approval and a signed data-sharing agreement.
Data will be provided solely for the purposes specified in the approved proposal.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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