NCT04037579

Brief 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."

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 26, 2019

Last Update Submit

July 30, 2019

Conditions

Keywords

physical activityself-determinationSocial inclusionWell-beingRightsInterpersonal relations

Outcome Measures

Primary Outcomes (1)

  • Sport effect on social skills in Down Syndrome people

    To Evaluate sport effect on social skills in Down Syndrome people using a survey

    6 months

Secondary Outcomes (1)

  • Types of physical activities carried out by Down Syndrome people

    6 months

Study Arms (6)

Down Syndrome Cordoba Association

The participant will answer a questionnaire related to social skills and physical activity

Other: Survey

Down Syndrome Granada Association

The participant will answer a questionnaire related to social skills and physical activity

Other: Survey

Down Syndrome Malaga Association

The participant will answer a questionnaire related to social skills and physical activity

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

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

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

Other: Survey

Interventions

SurveyOTHER

Non-randomised survey

Down Syndrome Cordoba AssociationDown Syndrome Granada AssociationDown Syndrome Malaga AssociationObservers in CordobaObservers in GranadaObservers in Malaga

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.).

You may qualify if:

  • Down syndrome
  • Do sport
  • Belonging to Cordoba, Mágala and Granada Associatio

You may not qualify if:

  • Others metal incapacities
  • Others Asociation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Estrella Agüera

Córdoba, 14071, Spain

Location

MeSH Terms

Conditions

Down SyndromeSocial SkillsMotor ActivitySocial Inclusion

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Estrella Agüera, Dotor

    Universidad de Córdoba

    STUDY DIRECTOR

Central Study Contacts

Estrella Agüera, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor. Responsible of AGR-019 Research Group

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

September 26, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available within 6 months of study completion
Access Criteria
Data access request will be reviewed by an external Independent Review Panel. Requestors will be required to sing a Data Access Agreement.

Locations