- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863625
Effects of a Peer-led Educational Intervention Based on Theory of Planned Behavior on Substance Use Intentions and Behaviors Among Secondary School Students of Dessie and Kombolcha Town, Northeast Ethiopia.
April 26, 2022 updated by: Yitbarek Wasihun, Wollo University
Effects of a Peer-led Educational Intervention Based on Theory of Planned Behavior on Substance Use Intentions and Behaviors Among Secondary School Students of Dessie and Kombolcha Town, Northeast Ethiopia: a Quasi- Experimental Study
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
1496
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Addise Abeba
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Dessie, Addise Abeba, Ethiopia, 1145
- Wollo University
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-
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
15 years to 24 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental group
748 students from two secondary schools for the intervention group will be selected and participated in a peer led education process on substance use (smoking, drinking and chewing) prevention based on the Theory of Planned Behavior (TPB).
|
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.
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NO_INTERVENTION: Control group
748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Intention to smoke cigarette over a 3-month period
Time Frame: Three months
|
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
|
|
Behavioral Intention to drink alcohol over a 3-month period
Time Frame: Three months
|
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
|
|
Behavioral Intention to chew khat over a 3-month period
Time Frame: Three months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
May 15, 2021
Primary Completion (ACTUAL)
August 30, 2021
Study Completion (ACTUAL)
August 30, 2021
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (ACTUAL)
April 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 27, 2022
Last Update Submitted That Met QC Criteria
April 26, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All individual participant data will be available to other researchers during and after publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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