NCT02629679

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

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

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 2, 2015

Last Update Submit

December 11, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    2 years

Secondary Outcomes (2)

  • Exact number of participants who failed educationally as assessed by grade-point average

    2 years

  • Exact number of participants who failed educationally as assessed by behavioral grade

    2 years

Study Arms (4)

Males nonathletes

Boys non-involved in organized sport and exercising

Behavioral: Regular scholastic system

Females nonathletes

Girls non-involved in organized sport and exercising

Behavioral: Regular scholastic system

Males athletes

Athletic boys (involved in sports)

Behavioral: Regular scholastic system and organized sports

Females athletes

Athletic girls (involved in sports)

Behavioral: Regular scholastic system and organized sports

Interventions

This group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs

Females athletesMales athletes

The group will consist of children who are regularly in school, but not being involved in organized sport activities

Females nonathletesMales nonathletes

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Children involved in regular scholastic system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 26546145BACKGROUND
  • 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.

    PMID: 26068091BACKGROUND
  • 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.

    PMID: 26294308BACKGROUND
  • 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.

    PMID: 22480230BACKGROUND
  • 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.

    PMID: 21612340BACKGROUND

MeSH Terms

Conditions

Cigarette SmokingAlcohol Drinking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseDrinking Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Damir Sekulic

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 14, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

December 14, 2015

Record last verified: 2015-12