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

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.

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.

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.

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