NCT07184164

Brief Summary

The aim of study was to effect of educational program by using behavior change wheel model on knowledge, behavior and involvement in substance abuse among adolescents. The design of this study was a quasi-experimental design and the target population for the study was adolescents. Research hypothesis \- The application of an educational program based on behavior change wheel model has a positive impact on knowledge, behavior and involvement in substance abuse among adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

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

Study Start

First participant enrolled

May 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 14, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

AdolescentAlcohol and Drug InvolvementBehavior Change WheelSubstance abuseknowledge

Outcome Measures

Primary Outcomes (3)

  • Adolescents' behavior changes related to COM-B part of Behavior Change Wheel assessment form

    This tool assesses adolescents' behavior changes related to substance abuse using the COM-B model (Capability, Opportunity, Motivation). It consists of 15 items measuring adolescents' feelings and experiences related to substance use. Scoring ranges from 0 to 30, with a cutoff of 60% (18 points) indicating satisfactory behavior change. Validity and reliability were established through expert review and a Cronbach's alpha greater than 0.80.

    3 months

  • Reported assessment checklist of the second layer of Behavior Change Wheel

    This checklist evaluates adolescents' knowledge and practices regarding substance abuse through two parts: knowledge assessment with 10 items and reported practices across nine intervention functions. Each section uses varying scoring systems with cutoff points at 60% for satisfactory performance. The tool's validity and reliability were confirmed by experts and a Cronbach's alpha above 0.81.

    3 months

  • Adolescent Alcohol and Drug Involvement Scale (AADIS)

    The AADIS is a standardized self-report tool measuring adolescents' frequency of alcohol and drug use over the past month. It includes 14 items, where higher scores indicate greater substance use involvement. A cutoff score of 37 is used to identify potential substance use disorders based on DSM-IV criteria. Interpretations range from no use (0) to possible substance use disorder (37 or higher).

    3 Months

Study Arms (2)

Study Group

EXPERIMENTAL

Educational Program by Using Behavior Change Wheel Model

Behavioral: Educational Program by Using Behavior Change Wheel Model

Control Group

ACTIVE COMPARATOR

Routine health education

Behavioral: Routine Health Education

Interventions

The BCW model includes three layers: the behavior system, intervention functions, and policy categories, with the last not being applied in this study. The research was structured into four phases: assessment, planning, implementation, and evaluation. Phases of the Study Assessment Phase: Researchers introduced themselves to parents and adolescents through personal interviews, explaining the study's significance. They collected demographic data in the forensic and toxicology department, using various tools to assess adolescents' behaviors before the educational program. Planning Phase: A tailored BCW model encompassed a wide range of educational interventions. The content

Study Group

Participants in the control group received the routine health education and advice from nurses and healthcare providers working in the study settings

Control Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages between 10 and 18 years
  • had no history of receiving prior educational program

You may not qualify if:

  • Cardiac disease
  • Pulmonary disease
  • Liver function disorders
  • Renal impairment
  • Psychological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32514, Egypt

Location

Related Publications (2)

  • Gilchrist E, Johnson A, McMurran M, Stephens-Lewis D, Kirkpatrick S, Gardner B, Easton C, Gilchrist G. Using the Behaviour Change Wheel to design an intervention for partner abusive men in drug and alcohol treatment. Pilot Feasibility Stud. 2021 Oct 28;7(1):191. doi: 10.1186/s40814-021-00911-2.

    PMID: 34711276BACKGROUND
  • Alarco-Rosales R, Sanchez-SanSegundo M, Ferrer-Cascales R, Albaladejo-Blazquez N, Lordan O, Zaragoza-Marti A. Effects of a School-Based Intervention for Preventing Substance Use among Adolescents at Risk of Academic Failure: A Pilot Study of the Reasoning and Rehabilitation V2 Program. Healthcare (Basel). 2021 Nov 1;9(11):1488. doi: 10.3390/healthcare9111488.

    PMID: 34828534BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Mohamed A Shehata, Professor

    Menoufia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

May 13, 2023

Primary Completion

April 15, 2024

Study Completion

May 16, 2024

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations