SCOPE and Special Olympics (SCOPE/SO)

October 11, 2017 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States
        • Texas Woman's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • new members (within 2 years),
  • English-speaking,
  • U.S. citizens, and
  • must be 7 years or older at the time of assess.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Special Olympic athletes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short Child Occupational Profile
Time Frame: up to 3 years-estimated
To determine if there is a change in levels of participation in other areas of life for athletes involved in Special Olympics
up to 3 years-estimated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Woman's University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patricia Bowyer, EdD, OTR, BCN, FAOTA, Texas Woman's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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