Down SyndromeNCT04037579
Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
An observational study of Down Syndrome and Social Skills, run by Universidad de Córdoba at 1 site in Spain.
Trial summary
This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities." Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Down Syndrome, Social Skills, Physical Activity
- What is being tested?
- Survey
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 26 Sep 2019to Dec 2019
- 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 10 to 25 years
- All sexes
- Child, Adult
Study population: Down Syndrome people who practise sports and a people who know them well (at least for six months) and who have the opportunity to observe person evaluated for extended periods of time (parents, family, tutors, teachers etc.).
Who may be able to join
- Down syndrome
- Do sport
- Belonging to Cordoba, Mágala and Granada Associatio
Who cannot join
- Others metal incapacities
- Others Asociation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for a Non-randomized Survey to Evaluate Social Skills and Physical Capacity Improvement in Down Syndrome People Who Routinely Practice Sports. Self and Observers´ Perception.
This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities."
Read the detailed description
This study is a non-randomized survey. The aim of the current protocol is to describe how will be the process to get information about the participant, the questionnaire design and how was validated and the planned analysis of results.
Participants: Around 150 Down Syndrome people from Cordoba, Malaga y Granada who belong to The Down Syndrome association and 150 parents, family, tutors, teachers etc.
Consent process: Before designing the survey, consent was requested from the management team Down of Córdoba, Malaga and Gradana associations, as well as family members, parents, tutors, teachers, etc.
Standard Operating Procedures: First, RC (author) gathered as much information as possible about the subject under study and selected the most important topics related to the research focus. After that, the questionnaire was designed modifying the KidsLife-Down Scale. The questionnaire will be divided into three parts.
An introduction to the questionnaire describes the instructions, structure, the reasons for the study and confidentiality in accordance with the Spanish Organic Law 3/2018 on the Protection.
The first part of the questionnaire will assess self-perception from people with Down about their social skills. The second will evaluate the opinion of this issue from other people who know them well (at least for six months) and who have the opportunity to observe the person evaluated for extended periods of time (parents, family, tutors, teachers etc.). Finally, for the third part, it will be used the International Physical Activity Questionnaire (IPAQ) for the purpose of collecting information about the types of physical activity do in their daily routines. The questions will be referred to the time they have been physically active in the last 7 days.
Second, the questionnaire was sent to the Down Syndrome Association of Córdoba (DSAC) so that they reviewed the possible mistakes made when defining the questions and validate it. After that, Down Malaga and Down Granada Association found the questionnaire understandable and acceptable.
Third, they gave the corresponding feedback that served to formulate the questions in the appropriate way to avoid confusion in the surveyed.
The questionnaire will be sent by e-mail to the Cordoba Association and a paper version will available for participants. From Córdoba, it will be spread to Málaga and Granada Associations in order it will be distributed among associates.
Analysis of results: Estimated outcomes will be percentages of agreement with each answer. Data from all surveys will be analyzed. The statistical study will be carried out with the SPSS 24.0 program. The mean value and standard deviation (± SD) of each item will be calculated on a numerical scale. Statistical analysis will be performed with parametric tests, t-Student for related samples. The level of statistical significance will be calculated.
Two of the authors (RC and JC) will analyse de data, and results will be discussed among the work team.
Conducting a pilot test or pre-test before applying the survey will help to detect possible failures and optimize the results of our survey. Despite its importance, should not consider the pilot study as a substitute for a careful wording of the questionnaire.
Report on the survey: Before writing the report, It will be reviewed the data for errors and inconsistencies. Make sure the data reflects exactly what the survey concludes. The conclusion will summarize the results.
- Conditions
- Down Syndrome, Social Skills, Physical Activity
- Being tested
- Survey
- Keywords
- physical activity, self-determination, Social inclusion, Well-being, Rights, Interpersonal relations
- Medical subject headings
- Down Syndrome, Social Skills, Motor Activity, Social Inclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Non-randomised survey
| Study group | Role | What they receive |
|---|---|---|
| Down Syndrome Cordoba Association | The participant will answer a questionnaire related to social skills and physical activity Receives: Other: Survey | |
| Down Syndrome Granada Association | The participant will answer a questionnaire related to social skills and physical activity Receives: Other: Survey | |
| Down Syndrome Malaga Association | The participant will answer a questionnaire related to social skills and physical activity Receives: Other: Survey | |
| Observers in Cordoba | Observers from Cordoba, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity Receives: Other: Survey | |
| Observers in Granada | Observers from Granada, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity Receives: Other: Survey | |
| Observers in Malaga | Observers from Malaga, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sport effect on social skills in Down Syndrome people
To Evaluate sport effect on social skills in Down Syndrome people using a survey
Measured: 6 months
Secondary outcomes (1)
Types of physical activities carried out by Down Syndrome people
To know which types of physical activities are carried out by Down Syndrome people using a survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start26 Sep 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estrella Agüera Buendía, Universidad de Córdoba
- Investigators
- Estrella Agüera, Dotor, Study director, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037579
- Sponsor's protocol ID
- University of Cordoba, Spain
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Non-randomized Survey to Evaluate Social Skills and Physical Capacity Improvement in Down Syndrome People Who Routinely Practice Sports. Self and Observers´ Perception.
- ClinicalTrials.gov ID
- NCT04037579
- Acronym / sponsor ID
- University of Cordoba, Spain
- Conditions
- Down Syndrome, Social Skills, Physical Activity
- Keywords
- physical activity, self-determination, Social inclusion, Well-being, Rights, Interpersonal relations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 26 Sep 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Jul 2019 (actual)
- 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.
This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities."
Detailed description
This study is a non-randomized survey. The aim of the current protocol is to describe how will be the process to get information about the participant, the questionnaire design and how was validated and the planned analysis of results.
Participants: Around 150 Down Syndrome people from Cordoba, Malaga y Granada who belong to The Down Syndrome association and 150 parents, family, tutors, teachers etc.
Consent process: Before designing the survey, consent was requested from the management team Down of Córdoba, Malaga and Gradana associations, as well as family members, parents, tutors, teachers, etc.
Standard Operating Procedures: First, RC (author) gathered as much information as possible about the subject under study and selected the most important topics related to the research focus. After that, the questionnaire was designed modifying the KidsLife-Down Scale. The questionnaire will be divided into three parts.
An introduction to the questionnaire describes the instructions, structure, the reasons for the study and confidentiality in accordance with the Spanish Organic Law 3/2018 on the Protection.
The first part of the questionnaire will assess self-perception from people with Down about their social skills. The second will evaluate the opinion of this issue from other people who know them well (at least for six months) and who have the opportunity to observe the person evaluated for extended periods of time (parents, family, tutors, teachers etc.). Finally, for the third part, it will be used the International Physical Activity Questionnaire (IPAQ) for the purpose of collecting information about the types of physical activity do in their daily routines. The questions will be referred to the time they have been physically active in the last 7 days.
Second, the questionnaire was sent to the Down Syndrome Association of Córdoba (DSAC) so that they reviewed the possible mistakes made when defining the questions and validate it. After that, Down Malaga and Down Granada Association found the questionnaire understandable and acceptable.
Third, they gave the corresponding feedback that served to formulate the questions in the appropriate way to avoid confusion in the surveyed.
The questionnaire will be sent by e-mail to the Cordoba Association and a paper version will available for participants. From Córdoba, it will be spread to Málaga and Granada Associations in order it will be distributed among associates.
Analysis of results: Estimated outcomes will be percentages of agreement with each answer. Data from all surveys will be analyzed. The statistical study will be carried out with the SPSS 24.0 program. The mean value and standard deviation (± SD) of each item will be calculated on a numerical scale. Statistical analysis will be performed with parametric tests, t-Student for related samples. The level of statistical significance will be calculated.
Two of the authors (RC and JC) will analyse de data, and results will be discussed among the work team.
Conducting a pilot test or pre-test before applying the survey will help to detect possible failures and optimize the results of our survey. Despite its importance, should not consider the pilot study as a substitute for a careful wording of the questionnaire.
Report on the survey: Before writing the report, It will be reviewed the data for errors and inconsistencies. Make sure the data reflects exactly what the survey concludes. The conclusion will summarize the results.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome Cordoba Association | – | Other: SurveyThe participant will answer a questionnaire related to social skills and physical activity |
| Down Syndrome Granada Association | – | Other: SurveyThe participant will answer a questionnaire related to social skills and physical activity |
| Down Syndrome Malaga Association | – | Other: SurveyThe participant will answer a questionnaire related to social skills and physical activity |
| Observers in Cordoba | – | Other: SurveyObservers from Cordoba, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity |
| Observers in Granada | – | Other: SurveyObservers from Granada, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity |
| Observers in Malaga | – | Other: SurveyObservers from Malaga, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Down Syndrome people who practise sports and a people who know them well (at least for six months) and who have the opportunity to observe person evaluated for extended periods of time (parents, family, tutors, teachers etc.).
Key inclusion criteria (3 listed)
- Down syndrome
- Do sport
- Belonging to Cordoba, Mágala and Granada Associatio
Key exclusion criteria (2 listed)
- Others metal incapacities
- Others Asociation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyNon-randomised survey | Other | Down Syndrome Cordoba Association, Down Syndrome Granada Association, Down Syndrome Malaga Association, Observers in Cordoba, Observers in Granada, Observers in Malaga |
Primary outcome
Sport effect on social skills in Down Syndrome people
Time frame: 6 months
To Evaluate sport effect on social skills in Down Syndrome people using a survey
1 secondary outcome
Types of physical activities carried out by Down Syndrome people
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Estrella Agüera, Dotor study director
Universidad de Córdoba
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 Down Syndrome and Social Skills, run by Universidad de Córdoba at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Estrella Agüera, Doctor (+34669808974, ba1agbue@uco.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sport effect on social skills in Down Syndrome people (time frame: 6 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 31 Jul 2019.