search
Back to results

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.

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors
Sponsored by
Wollo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Substance use, alcohol ,cigarette and Khat

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wollo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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).

748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2021
Last Updated
April 26, 2022
Sponsor
Wollo University
Collaborators
Jimma University
search

1. Study Identification

Unique Protocol Identification Number
NCT04863625
Brief 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.
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wollo University
Collaborators
Jimma University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Substance use, alcohol ,cigarette and Khat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
1496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum.
Intervention Type
Behavioral
Intervention Name(s)
a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral Intention to smoke cigarette over a 3-month period
Description
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.
Time Frame
Three months
Title
Behavioral Intention to drink alcohol over a 3-month period
Description
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.
Time Frame
Three months
Title
Behavioral Intention to chew khat over a 3-month period
Description
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
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wollo University
City
Dessie
State/Province
Addise Abeba
ZIP/Postal Code
1145
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All individual participant data will be available to other researchers during and after publication

Learn more about this trial

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.

We'll reach out to this number within 24 hrs