Substance UseNCT04863625
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 study testing a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors in people with Substance Use, run by Wollo University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Substance Use
- What is being tested?
- a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,496 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 May 2021to 30 Aug 2021
- Phase
- Interventional
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors
- Keywords
- Substance use, alcohol ,cigarette and Khat
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviorsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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). Receives: Behavioral: a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors |
| Control group | No intervention | 748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
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.
Measured: Three months
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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start15 May 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be a peer education process on substance use (smoking, drinking and chewing) prevention based on the Theory of Planned Behavior (TPB). This program is a Level I, primary prevention; thus, it is an early intervention program. The program is targeting students with all substance experience (non-user, current user, and ever users). 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.
- Masking
- None (open label)
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University
- Responsible party
- Principal investigator, Yitbarek Wasihun, Wollo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863625
- Sponsor's protocol ID
- 2021
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual participant data will be available to other researchers during and after publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04863625
- Acronym / sponsor ID
- 2021
- Conditions
- Substance Use
- Keywords
- Substance use, alcohol ,cigarette and Khat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Collaborators
- Jimma University
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be a peer education process on substance use (smoking, drinking and chewing) prevention based on the Theory of Planned Behavior (TPB). This program is a Level I, primary prevention; thus, it is an early intervention program. The program is targeting students with all substance experience (non-user, current user, and ever users). 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors748 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). |
| Control group | No intervention | –748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviorsThe 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No. All individual participant data will be available to other researchers during and after publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors in people with Substance Use, run by Wollo University at 1 site in Ethiopia.
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: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral Intention to smoke cigarette over a 3-month period (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022.