Structured Sensory-Based Occupational Therapy in Children With Autism
7. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Emre Dansuk, PhD
- Telefonnummer: 05377790434
- E-Mail: edansuk@medipol.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Burak Menek, PhD
Studienorte
-
-
Beykoz
-
Istanbul, Beykoz, Türkei (türkiye), 34815
- Rekrutierung
- Emre Dansuk
-
Kontakt:
- Emre Dansuk, PhD
- Telefonnummer: 05377790434
- E-Mail: edansuk@medipol.edu.tr
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Aktiver Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Occupational Performance
Zeitfenster: Baseline and Week 12
|
Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure.
Higher scores will indicate better perceived occupational performance.
|
Baseline and Week 12
|
|
Change in Satisfaction with Occupational Performance
Zeitfenster: 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.
|
Baseline and Week 12
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Sensory Processing
Zeitfenster: 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
Zeitfenster: 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.
|
Baseline and Week 12
|
|
Change in Eating Behaviors
Zeitfenster: Baseline and Week 12
|
Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.
|
Baseline and Week 12
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Emre DANSUK, PhD, Medipol University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
28. August 2026
Primärer Abschluss (Geschätzt)
1. November 2026
Studienabschluss (Geschätzt)
1. November 2026
Studienanmeldedaten
Zuerst eingereicht
24. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. August 2026
Zuerst gepostet (Tatsächlich)
27. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- E-10840098-202.3.02-4787
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
Beginning immediately after publication and available for five years.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .