- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629679
Sports, Education and Consumption of Substances in Adolescents (SESA)
December 11, 2015 updated by: Damir Sekulic, University Hospital of Split
Prospective Analysis of the Factors Associated With Substance Use and Misuse in Adolescents
Adolescent substance abuse (SA), which includes the consumption of alcohol, cigarette smoking, the consumption of drugs and other behaviors, is a significant public-health issue in the world today.
Recent data showed that prevalence of SA among adolescents in Croatia and surrounding countries (i.e.
former Yugoslav republics) is alarming and needs serious intervention.
It is hypothesized that participation in physical-exercise-and-sport (PE&S) will reduce the tendency of young people to abuse substances.
However, the literature to date has not consistently validated the perception PE&S factors are factors which could buffer SA among children and adolescents.
One of the probable reasons for evident inconsistencies on findings about relationship between PE&S and SA is a cross-sectional nature of studies done so far.
Therefore, the main rationale (i.e.
problem) of this study is lack of current knowledge about influence of the PE&S on SA among adolescents.
The main objective of this study is to prospectively investigate the influence of PE&S on SA among adolescents aged 17 to 18 years old.
Aims of the project are: (1) to define prevalence and trends of SA among adolescents aged 17 to 18 years old; (2) to define prevalence and trends of PE&S participation; (3) to establish interrelationships which exist between socio-demographic, psychological, educational-factors, and PE&S (predictors); (4) to identify multivariate and univariate associations between: socio-demographic and SA, psychological factors and SA, PE&S and SA, educational - scholastic factors and SA.Expected results of the project are: (1) definition of the prevalence of SA among adolescents; (2) definition of the adolescents' participation in PE&S; (3) identification and interpretation relationships which exist between and within studied predictors of SA (educational factors, socio-demographic factors, PE&S, psychological factors); (4) identification of the influence of studied predictors on SA.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1000
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
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The sample will comprise approximately 1,000 participants (50% males).
At the beginning of the study, the participants will be attending the 3rd year (grade) of high school, and therefore practically all subjects will be 17 years of age at the moment the study starts (+/- 6 months).
Participants will be randomly selected from 10 to 15 high schools which offer a 4-year high school education.
Because of the prospective study design and consequent need to repeatedly test the same participants, only those schools where the investigators already have personal and professional contacts with the school authorities will be used as possible test environments.
Description
Inclusion Criteria:
- Children involved in regular scholastic system
Exclusion Criteria:
- No
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Males nonathletes
Boys non-involved in organized sport and exercising
|
The group will consist of children who are regularly in school, but not being involved in organized sport activities
|
|
Females nonathletes
Girls non-involved in organized sport and exercising
|
The group will consist of children who are regularly in school, but not being involved in organized sport activities
|
|
Males athletes
Athletic boys (involved in sports)
|
This group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs
|
|
Females athletes
Athletic girls (involved in sports)
|
This group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exact number of participants who smoke cigarettes as assessed by QSU questionnaire
Time Frame: 2 years
|
QSU - Questionnaire of Substance Use is validated questionnaire where participants are asked on their consumption of substances, including cigarette smoking
|
2 years
|
|
Exact number of participants involved in harmful alcohol drinking as assessed by AUDIT questionnaire
Time Frame: 2 years
|
AUDIT - Alcohol Use Disorders Identification Test is a common and valid questionnaire where subjects are tested on alcohol drinking habits
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exact number of participants who failed educationally as assessed by grade-point average
Time Frame: 2 years
|
Grade-point-average is one of the scholastic-achievement variables.
|
2 years
|
|
Exact number of participants who failed educationally as assessed by behavioral grade
Time Frame: 2 years
|
Behavioral-grade is one of the scholastic-achievement variables.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zenic N, Ostojic L, Sisic N, Pojskic H, Peric M, Uljevic O, Sekulic D. Examination of the community-specific prevalence of and factors associated with substance use and misuse among Rural and Urban adolescents: a cross-sectional analysis in Bosnia and Herzegovina. BMJ Open. 2015 Nov 6;5(11):e009446. doi: 10.1136/bmjopen-2015-009446.
- Zenic N, Terzic A, Rodek J, Spasic M, Sekulic D. Gender-Specific Analyses of the Prevalence and Factors Associated with Substance Use and Misuse among Bosniak Adolescents. Int J Environ Res Public Health. 2015 Jun 10;12(6):6626-40. doi: 10.3390/ijerph120606626.
- Idrizovic K, Zenic N, Tahirajl E, Rausavljevic N, Sekulic D. CIGARETTE SMOKING AMONG 17-18 YEAR OLD ADOLESCENTS - PREVALENCE AND ASSOCIATION WITH SOCIODEMOGRAPHIC, FAMILIAL, SPORT, AND SCHOLASTIC. FACTORS. Med Pr. 2015;66(2):153-63. doi: 10.13075/mp.5893.00104.
- Sekulic D, Ostojic M, Ostojic Z, Hajdarevic B, Ostojic L. Substance abuse prevalence and its relation to scholastic achievement and sport factors: an analysis among adolescents of the Herzegovina-Neretva Canton in Bosnia and Herzegovina. BMC Public Health. 2012 Apr 5;12:274. doi: 10.1186/1471-2458-12-274.
- Modric T, Zenic N, Sekulic D. Substance use and misuse among 17- to 18-year-old Croatian adolescents: correlation with scholastic variables and sport factors. Subst Use Misuse. 2011;46(10):1328-34. doi: 10.3109/10826084.2011.579677. Epub 2011 May 25.
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
September 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
December 2, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 14, 2015
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 11, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01111705/2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
Penn State UniversityNot yet recruiting
-
Boston University Charles River CampusActive, not recruiting
-
Binghamton UniversityNot yet recruitingUnderage Drinking | Drinking, Teen | Adolescent Alcohol UseUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
The University of Hong KongRecruitingmHealth Intervention | AlcoholHong Kong
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
Clinical Trials on Regular scholastic system
-
Skane University HospitalCompletedICP Regulation Using a New Device for Automated Zero-calibration for a Ventricular Drainage SystemSweden
-
Karolinska InstitutetMinistry of Health and Social Affairs, SwedenCompleted
-
Shanghai SIMR Biotechnology Co., Ltd.Recruiting
-
University Hospital, MontpellierTerminatedthe Management of Weight Regain After Gastric Bypass by Endoscopic SuturingFrance
-
University Hospital, ToulouseRecruiting
-
Hospital Universitario de CanariasCompletedAdenoma Detection RateSpain
-
Samsung Medical CenterCompletedPhysical Activity | Diabetes (DM)
-
University of ValenciaCompleted
-
Peking Union Medical College HospitalCompletedCardiovascular Abnormalities | Perioperative/Postoperative Complications | Ultrasound Therapy; Complications | Vascular Access ComplicationChina
-
Federal University of PelotasUnknown