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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Ethiopia
    • Addise Abeba
      • Dessie, Addise Abeba, Ethiopia, 1145
        • Wollo University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
NO_INTERVENTION: Control group
748 students from two secondary schools for the control group will selected and receive t their school's regular curriculum.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wollo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jimma University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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