- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01895907
SCOPE and Special Olympics (SCOPE/SO)
11. oktober 2017 oppdatert av: Texas Woman's University
The purpose of this study is to examine if Special Olympic athletes's life participation improves through involvement with Special Olympics.
This project will be undertaken in coordination with Special Olympics entities from Texas and around the nation to determine how involvement in Special Olympics improves the strengths and limitations of their athletes.
The Short Child Occupational Profile (SCOPE) will be used to gather this information from the parents and coaches.
The SCOPE measures the impact that personal and environmental factors have on a child or youth's occupational participation.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
The research team members will not have contact with the Special Olympic athletes.
Parents and coaches will be the only individuals who have contact with the athletes.
Participants will be assured that their participation is completely voluntary.
If they agree to participate in the research an informed assest form will be explained by a parent, guardian, or coach and they will be asked to sign it.
Parents will be asked to sign a consent form for their child's participation in the study.
Coaches will administer the SCOPE as a pre/post-test outcome measure.
Parents will submit the Parent form of the SCOPE and the coaches will submit the SCOPE Clinical Data Summary Form.
All data will be de-identified and sent in form the coaches.
The TWU special olympics research team will compile de-identified data from a pre-test and post-test utilizing the SCOPE.
A codebook that links the ID number with the participants will be kept by the coaches.
The research team may be able to trace assented data collected through the TWU data collection protocol back to the coaches.
Participating athletes will not be contacted by the PI and no contact information will be collected.
In the case of an unexpected or adverse event, or if the participants request to be contacted, attempts may be made to find the subjects contact information through the coaches.
De-identified data collected by the TWU Special Olympic research team or other Key Research personnel will be stored on a password protected computer or in a locked file cabinet in a locked office in the department of occupational therapy at Texas Woman's University in Houston.
The raw data collected will not be made available to anyone other than the PI and immediate study research personnel.
Data is entered into the database using the ID number, and the computer database is password protected.
The raw data is not going to be shared.
The data will be kept in a locked file cabinet within the research office of the databases destroyed 4 years after the end of the study.
The results of the analysis, which may include information from the data, will be kept on a password secure computer indefinitely.
The data collected from pre-tests and post-tests will then be compiled and analyzed.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Houston, Texas, Forente stater
- Texas Woman's University
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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
7 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participating athletes will be recruited through the coaches.
Participants recruited under the TWU collection protocol will be informed that they are being asked to be a subject in a research study to determine if there is a change in levels of participation in other areas of life for athletes involved in special olympics.
Beskrivelse
Inclusion Criteria:
- new members (within 2 years),
- English-speaking,
- U.S. citizens, and
- must be 7 years or older at the time of assess.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Special Olympic athletes
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Short Child Occupational Profile
Tidsramme: up to 3 years-estimated
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To determine if there is a change in levels of participation in other areas of life for athletes involved in Special Olympics
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up to 3 years-estimated
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patricia Bowyer, EdD, OTR, BCN, FAOTA, Texas Woman's University
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
1. mai 2010
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. november 2016
Datoer for studieregistrering
Først innsendt
5. juli 2013
Først innsendt som oppfylte QC-kriteriene
10. juli 2013
Først lagt ut (Anslag)
11. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2017
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 15528
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .