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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04863625
Other study ID # 2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date August 30, 2021

Study information

Verified date April 2022
Source Wollo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to measure the effects of a per-led educational intervention based on theory of planned behavior to reduce tobacco, alcohol and khat use and intention to use among secondary school students over 3-months of follow-up in Dessie and Kombolcha town, Northeast Ethiopia.


Description:

This study aims to measure the effects of a per-led educational intervention based on theory of planned behavior to reduce tobacco, alcohol and khat use and intention to use among secondary school students over 3-months of follow-up in Dessie and Kombolcha town, Northeast Ethiopia.A quasi-experimental nonequivalent control group pretest-post-test design will be carried out among secondary school students of Dessie and Kombolcha Town from April to August, 2021. Individuals/Students/ in those selected schools will be allocated as intervention and control group purposively. The study will include 748 students from two secondary schools for the intervention group and another 748 students for the control group from other two secondary schools. The per-educational intervention will be planned based on results of the elicitation and TPB constructs and will be implemented on the experimental group for three months. Both experimental and control groups will be followed up after three months of educational intervention using the same tools and methods on same participants interviewed in pretest survey. Primary outcomes are substance(Cigarette,alcohol and Khat) use intention and behavior. Secondary outcome are attitudes, subjective norms, and perceived behavioral control over substance(Cigarette,alcohol and Khat) use. Self-administered questionnaire based on TPB constructs will be used to collect the baseline and follow up data. In-depth interviews will be employed to explore the salient beliefs about substance use. The data will be analyzed using SPSS statistical software package version 20 using appropriate statistical tests including paired t-test, independent t-tests, McNemar and multivariate logistic regression analysis. All statistical tests will be carried out using two tailed tests with alpha set at 0.05. Information from the interviews will be transcribed verbatim, analyzed, and coded thematically.


Recruitment information / eligibility

Status Completed
Enrollment 1496
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - All Grade 9-12 students, both girls and boys with any substance use experience (non-user, current user, and ever users) (aged 15-24 years) attending the four secondary schools of Dessie and Kombolcha town are eligible. Exclusion Criteria: - Grade 9-12 students who are not wanting to attend the evaluation and not able to have a follow- up will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors
The intervention will be a peer led education process on substance use (smoking, drinking and chewing) prevention based on the Theory of Planned Behavior (TPB).The intervention aims to encourage anti-substance attitudes and beliefs; foster perceptions of normative support for anti-substance behavior; increase perceptions of control/self-efficacy to resist substance use, increase knowledge and risk perceptions on substance and decrease in intention to use substance and actual substance use behaviors. Six education sessions will be delivered, with one session occurring each week. Each session will be lasted 40-55 minutes. The intervention will be conducted in 30 groups of selected students from grade 9-12, a pair of peer educators will educate a 30 sized group weekly (30 students /group)/ classrooms at pre-assigned time during class periods. The six sessions will be guided by four student training modules.

Locations

Country Name City State
Ethiopia Wollo University Dessie Addise Abeba

Sponsors (2)

Lead Sponsor Collaborator
Wollo University Jimma University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral Intention to smoke cigarette over a 3-month period It is the secondary school student motivation in the sense of his/her conscious plan to exert such behavior, intent to use cigarette. It will be assessed by a 3-item self-report questionnaire designed for the study, based on the manual for constructing questionnaires based on the TPB (Francis, et al. 2004). Participants could score between 3 -21, with a low score indicating no intention to use tobacco, over a 3-month period and a high score indicating an intention to use tobacco over a 3-month periods. Three months
Primary Behavioral Intention to drink alcohol over a 3-month period It is the secondary school student motivation in the sense of his/her conscious plan to exert such behavior, intent to use alcohol. It will be assessed by a 3-item self- report questionnaire designed for the study, based on the manual for constructing questionnaires based on the TPB (Francis, et al. 2004). Participants could score between 3 -21, with a low score indicating no intention to use alcohol, over a 3-month period and a high score indicating an intention to use alcohol over a 3-month periods. Three months
Primary Behavioral Intention to chew khat over a 3-month period It is the secondary school student motivation in the sense of his/her conscious plan to exert such behavior, intent to use khat. It will be assessed by a 3-item self-report questionnaire designed for the study, based on the manual for constructing questionnaires based on the TPB (Francis, et al. 2004). Participants could score between 3 -21, with a low score indicating no intention to use khat, over a 3-month period and a high score indicating an intention to use khat over a 3-month periods Three months
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