- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04879303
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
16. august 2021 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Eva Yin-han Chung, PhD
- Telefonnummer: +852 29488233
- E-post: chunge@eduhk.hk
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- The Education University of Hong Kong
-
Ta kontakt med:
- Eva Yin-han Chung, PhD
- Telefonnummer: +852 29488233
- E-post: chunge@eduhk.hk
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
5 år til 11 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Robot-assisted social skill intervention
Social robotics will be used by the instructor to conduct the social skill training activities.
|
Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
|
|
Aktiv komparator: Human-only instruction program on social skill training
The children will receive only the human-delivered social skill training.
|
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.
|
|
Ingen inngripen: Control
There will be no intervention conducted during the tested period
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Autism Diagnostic Observation Schedule
Tidsramme: 1 week before 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.
|
1 week before the intervention
|
|
The Autism Diagnostic Observation Schedule
Tidsramme: 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.
|
1 week after the intervention
|
|
Social Responsiveness Scale
Tidsramme: 1 week before the intervention
|
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.
|
1 week before the intervention
|
|
Social Responsiveness Scale
Tidsramme: 1 week after the intervention
|
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.
|
1 week after the intervention
|
|
The Canadian Occupational Performance Measure
Tidsramme: 1 week before 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.
|
1 week before the intervention
|
|
The Canadian Occupational Performance Measure
Tidsramme: 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.
|
1 week after the intervention
|
|
Short sensory profile
Tidsramme: 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.
|
1 week before the intervention
|
|
Short sensory profile
Tidsramme: 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.
|
1 week after the intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Eva Yin-han Chung, PhD, The Education University of Hong Kong
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. mai 2021
Primær fullføring (Forventet)
1. oktober 2021
Studiet fullført (Forventet)
30. juni 2022
Datoer for studieregistrering
Først innsendt
19. april 2021
Først innsendt som oppfylte QC-kriteriene
7. mai 2021
Først lagt ut (Faktiske)
10. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R1230
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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