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- Klinische proef NCT04879303
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
16 augustus 2021 bijgewerkt door: Eva Chung Yin-han, Education University of Hong Kong
This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context.
The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework.
Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework.
Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework.
With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.
Studie Overzicht
Toestand
Werving
Studietype
Ingrijpend
Inschrijving (Verwacht)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Eva Yin-han Chung, PhD
- Telefoonnummer: +852 29488233
- E-mail: chunge@eduhk.hk
Studie Locaties
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-
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Hong Kong, Hongkong
- Werving
- The Education University of Hong Kong
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Contact:
- Eva Yin-han Chung, PhD
- Telefoonnummer: +852 29488233
- E-mail: chunge@eduhk.hk
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
5 jaar tot 11 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- clinical diagnosis of autism spectrum disorder
- aged between 5-11
- normal intelligence
Exclusion Criteria:
- with self-injurious or aggressive behavior
- with hearing or visual impairment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Robot-assisted social skill intervention
Social robotics will be used by the instructor to conduct the social skill training activities.
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Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
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Actieve vergelijker: Human-only instruction program on social skill training
The children will receive only the human-delivered social skill training.
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The children will receive only the human-delivered training throughout the 12 sessions, with the content and sequence of activities the same as the robotic intervention group.
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Geen tussenkomst: Control
There will be no intervention conducted during the tested period
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The Autism Diagnostic Observation Schedule
Tijdsspanne: 1 week before the intervention
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The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play.
It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment.
The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed.
It is individual-based and will take 30-45 minutes for administering.
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1 week before the intervention
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The Autism Diagnostic Observation Schedule
Tijdsspanne: 1 week after the intervention
|
The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play.
It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment.
The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed.
It is individual-based and will take 30-45 minutes for administering.
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1 week after the intervention
|
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Social Responsiveness Scale
Tijdsspanne: 1 week before the intervention
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The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items.
It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
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1 week before the intervention
|
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Social Responsiveness Scale
Tijdsspanne: 1 week after the intervention
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The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items.
It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
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1 week after the intervention
|
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The Canadian Occupational Performance Measure
Tijdsspanne: 1 week before the intervention
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The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation.
It will collect both quantitative and qualitative data.
The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
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1 week before the intervention
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The Canadian Occupational Performance Measure
Tijdsspanne: 1 week after the intervention
|
The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation.
It will collect both quantitative and qualitative data.
The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
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1 week after the intervention
|
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Short sensory profile
Tijdsspanne: 1 week before the intervention
|
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks.
This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses.
Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
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1 week before the intervention
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Short sensory profile
Tijdsspanne: 1 week after the intervention
|
The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks.
This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses.
Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
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1 week after the intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Eva Yin-han Chung, PhD, The Education University of Hong Kong
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 mei 2021
Primaire voltooiing (Verwacht)
1 oktober 2021
Studie voltooiing (Verwacht)
30 juni 2022
Studieregistratiedata
Eerst ingediend
19 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2021
Eerst geplaatst (Werkelijk)
10 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
16 augustus 2021
Laatst geverifieerd
1 augustus 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R1230
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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