To Determine the Psychometric Properties of the Short Child Occupational ProfileNCT01717365
Psychometric / Validation Study
An observational study of To Determine the Psychometric Properties of the Short Child Occupational Profile, run by Texas Woman's University at 1 site in United States.
Trial summary
Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- To Determine the Psychometric Properties of the Short Child Occupational Profile
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity.
Who may be able to join
- Subjects receiving therapy from participating therapists.
Who cannot join
- Age over 21.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCOPE: A Psychometric Study
Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. The TWU SCOPE research team has no contact with clients whose assessment data is being shared for secondary analysis or clinical data repository. For educational and training purposes clients can be videotaped by the therapist who will obtain consent and/or assent from the client. Not every client will be videotaped. The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity. The total amount of data collected from all participating therapists will be 500 pieces.
Read the detailed description
Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who wish to participate will send a data sharing letter to the PI of the study. Once the TWU SCOPE research team has received the data sharing letter, a clinical data packet will then be distributed to the therapist through the U.S. mail or an email will be sent containing a web address link to http://www.myweb.twu.edu/~ttioseco for access to the clinical data packet via the internet. Those therapists who collect ten pieces or more of de-identified data and send them to the TWU SCOPE research team will receive an incentive in the form of a gift card.
Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank (new de-identified data input) → data analysis (analysis of new and old de-identified data) → publication/presentation
No risks are involved because data collected is without any personal identifiers.
- Keywords
- SCOPE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OTs | Occupational therapists |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE
To determine the psychometric properties of the Short Child Occupational Profile (SCOPE) and validate the SCOPE.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Psychometric Properties of the Short Child Occupational ProfileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Bowyer, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717365
- Sponsor's protocol ID
- 15007
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOPE: A Psychometric Study
- ClinicalTrials.gov ID
- NCT01717365
- Acronym / sponsor ID
- 15007
- Keywords
- SCOPE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. The TWU SCOPE research team has no contact with clients whose assessment data is being shared for secondary analysis or clinical data repository. For educational and training purposes clients can be videotaped by the therapist who will obtain consent and/or assent from the client. Not every client will be videotaped. The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity. The total amount of data collected from all participating therapists will be 500 pieces.
Detailed description
Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who wish to participate will send a data sharing letter to the PI of the study. Once the TWU SCOPE research team has received the data sharing letter, a clinical data packet will then be distributed to the therapist through the U.S. mail or an email will be sent containing a web address link to http://www.myweb.twu.edu/~ttioseco for access to the clinical data packet via the internet. Those therapists who collect ten pieces or more of de-identified data and send them to the TWU SCOPE research team will receive an incentive in the form of a gift card.
Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank (new de-identified data input) → data analysis (analysis of new and old de-identified data) → publication/presentation
No risks are involved because data collected is without any personal identifiers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTs | – | –Occupational therapists |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity.
Key inclusion criteria (1 listed)
- Subjects receiving therapy from participating therapists.
Key exclusion criteria (1 listed)
- Age over 21.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE
Time frame: 36 months
To determine the psychometric properties of the Short Child Occupational Profile (SCOPE) and validate the SCOPE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Determine the Psychometric Properties of the Short Child Occupational Profile, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.