Structured Sensory-Based Occupational Therapy in Children With Autism
7 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Emre Dansuk, PhD
- Numéro de téléphone: 05377790434
- E-mail: edansuk@medipol.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Burak Menek, PhD
Lieux d'étude
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Beykoz
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Istanbul, Beykoz, Turquie (Türkiye), 34815
- Recrutement
- Emre Dansuk
-
Contact:
- Emre Dansuk, PhD
- Numéro de téléphone: 05377790434
- E-mail: edansuk@medipol.edu.tr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Occupational Performance
Délai: 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
Délai: Baseline and Week 12
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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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Sensory Processing
Délai: 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.
|
Baseline and Week 12
|
|
Change in Gross Motor Development
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Emre DANSUK, PhD, Medipol University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 août 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 novembre 2026
Dates d'inscription aux études
Première soumission
24 août 2026
Première soumission répondant aux critères de contrôle qualité
24 août 2026
Première publication (Réel)
27 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E-10840098-202.3.02-4787
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime 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.
Délai de partage IPD
Beginning immediately after publication and available for five years.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .