Cigarette SmokingSESANCT02629679
Sports, Education and Consumption of Substances in Adolescents
An observational study of Cigarette Smoking and Alcohol Drinking, run by University of Split.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Alcohol Drinking
- What is being tested?
- Regular scholastic system and organized sports and Regular scholastic system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jun 2016
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Children involved in regular scholastic system
Who cannot join
- No
About this study
Official title: 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.
- Conditions
- Cigarette Smoking, Alcohol Drinking
- Being tested
- Regular scholastic system and organized sports, Regular scholastic system
- Medical subject headings
- Cigarette Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular scholastic system and organized sportsBehavioural
This group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs
Regular scholastic systemBehavioural
The group will consist of children who are regularly in school, but not being involved in organized sport activities
| Study group | Role | What they receive |
|---|---|---|
| Males nonathletes | Boys non-involved in organized sport and exercising Receives: Behavioral: Regular scholastic system | |
| Females nonathletes | Girls non-involved in organized sport and exercising Receives: Behavioral: Regular scholastic system | |
| Males athletes | Athletic boys (involved in sports) Receives: Behavioral: Regular scholastic system and organized sports | |
| Females athletes | Athletic girls (involved in sports) Receives: Behavioral: Regular scholastic system and organized sports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exact number of participants who smoke cigarettes as assessed by QSU questionnaire
QSU - Questionnaire of Substance Use is validated questionnaire where participants are asked on their consumption of substances, including cigarette smoking
Measured: 2 years
Exact number of participants involved in harmful alcohol drinking as assessed by AUDIT questionnaire
AUDIT - Alcohol Use Disorders Identification Test is a common and valid questionnaire where subjects are tested on alcohol drinking habits
Measured: 2 years
Secondary outcomes (2)
Exact number of participants who failed educationally as assessed by grade-point average
Grade-point-average is one of the scholastic-achievement variables.
Measured: 2 years
Exact number of participants who failed educationally as assessed by behavioral grade
Behavioral-grade is one of the scholastic-achievement variables.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Damir Sekulic, University of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629679
- Sponsor's protocol ID
- 01111705/2015
- Acronym
- SESA
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26546145Zenic 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.
PubMed 26068091Idrizovic 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.
PubMed 26294308Sekulic 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.
PubMed 22480230Modric 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.
PubMed 21612340
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Factors Associated With Substance Use and Misuse in Adolescents
- ClinicalTrials.gov ID
- NCT02629679
- Acronym / sponsor ID
- SESA / 01111705/2015
- Conditions
- Cigarette Smoking, Alcohol Drinking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of SplitUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Dec 2015 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Males nonathletes | – | Behavioral: Regular scholastic systemBoys non-involved in organized sport and exercising |
| Females nonathletes | – | Behavioral: Regular scholastic systemGirls non-involved in organized sport and exercising |
| Males athletes | – | Behavioral: Regular scholastic system and organized sportsAthletic boys (involved in sports) |
| Females athletes | – | Behavioral: Regular scholastic system and organized sportsAthletic girls (involved in sports) |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children involved in regular scholastic system
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Regular scholastic system and organized sportsThis group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs | Behavioural | Females athletes, Males athletes |
| Regular scholastic systemThe group will consist of children who are regularly in school, but not being involved in organized sport activities | Behavioural | Females nonathletes, Males nonathletes |
Primary outcome
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
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 secondary outcomes
Exact number of participants who failed educationally as assessed by grade-point average
Time frame: 2 years
Exact number of participants who failed educationally as assessed by behavioral grade
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Background: PubMed 26546145Zenic 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.
- Background: PubMed 26068091Zenic 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.
- Background: PubMed 26294308Idrizovic 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.
- Background: PubMed 22480230Sekulic 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.
- Background: PubMed 21612340Modric 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking and Alcohol Drinking, run by University of Split.
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: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Exact number of participants who smoke cigarettes as assessed by QSU questionnaire (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629679, which also lists 5 linked publications.
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 14 Dec 2015.