NCT04863625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 26, 2021

Last Update Submit

April 26, 2022

Conditions

Keywords

Substance use, alcohol ,cigarette and Khat

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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).

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wollo University

Dessie, Addise Abeba, 1145, Ethiopia

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
EEffects 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 Record Dates

First Submitted

April 26, 2021

First Posted

April 28, 2021

Study Start

May 15, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

All individual participant data will be available to other researchers during and after publication

Locations