Substance Abuse ProblemNCT07184164
Effect of Educational Program on Knowledge, Behavior and Involvement in Substance Abuse Among Adolescents
A study testing Educational Program by Using Behavior Change Wheel Model and Routine Health Education in people with Substance Abuse Problem, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem
- What is being tested?
- Educational Program by Using Behavior Change Wheel Model and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2023to 16 May 2024
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages between 10 and 18 years
- had no history of receiving prior educational program
Who cannot join
- Cardiac disease
- Pulmonary disease
- Liver function disorders
- Renal impairment
- Psychological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Educational Program by Using Behavior Change Wheel Model on Knowledge, Behavior and Involvement in Substance Abuse Among Adolescents: A Quasi-experimental Study
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.
Read the detailed description
Substance abuse is of great concern to health issues worldwide, that typically initiated during adolescence, and it usually increases the likelihood of future physical, behavioral, social, and health issues. The Behavior Change Wheel can used as a practical and effective way of delivering real behavior change among adolescent's substance abuser. 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. Total 226 samples were selected using the convenient sampling technique. Tool of the study consists of four tools which includes Tool I: An interviewing structured questionnaire sheet, Tool (II): Adolescents' behavior changes related to COM-B part of Behavior Change Wheel assessment form: Tool (III): Reported assessment checklist of the second part of Behavior Change Wheel, and Tool IV: Adolescent Alcohol and Drug Involvement Scale (AADIS).
- Conditions
- Substance Abuse Problem
- Being tested
- Educational Program by Using Behavior Change Wheel Model, Routine Health Education
- Keywords
- Adolescent, Alcohol and Drug Involvement, Behavior Change Wheel, Substance abuse, knowledge
- 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.
Educational Program by Using Behavior Change Wheel ModelBehavioural
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
Routine Health EducationBehavioural
Participants in the control group received the routine health education and advice from nurses and healthcare providers working in the study settings
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Educational Program by Using Behavior Change Wheel Model Receives: Behavioral: Educational Program by Using Behavior Change Wheel Model |
| Control Group | Active comparator | Routine health education Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start13 May 2023
- Primary completion15 Apr 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse ProblemStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Mohamed A Shehata, Professor, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184164
- Sponsor's protocol ID
- 2/2023 FOR 11
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34711276Alarco-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.
PubMed 34828534
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educational Program by Using Behavior Change Wheel Model on Knowledge, Behavior and Involvement in Substance Abuse Among Adolescents: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07184164
- Acronym / sponsor ID
- 2/2023 FOR 11
- Conditions
- Substance Abuse Problem
- Keywords
- Adolescent, Alcohol and Drug Involvement, Behavior Change Wheel, Substance abuse, knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 19 Sep 2025 (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.
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.
Detailed description
Substance abuse is of great concern to health issues worldwide, that typically initiated during adolescence, and it usually increases the likelihood of future physical, behavioral, social, and health issues. The Behavior Change Wheel can used as a practical and effective way of delivering real behavior change among adolescent's substance abuser. 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. Total 226 samples were selected using the convenient sampling technique. Tool of the study consists of four tools which includes Tool I: An interviewing structured questionnaire sheet, Tool (II): Adolescents' behavior changes related to COM-B part of Behavior Change Wheel assessment form: Tool (III): Reported assessment checklist of the second part of Behavior Change Wheel, and Tool IV: Adolescent Alcohol and Drug Involvement Scale (AADIS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Educational Program by Using Behavior Change Wheel ModelEducational Program by Using Behavior Change Wheel Model |
| Control Group | Active comparator | Behavioral: Routine Health EducationRoutine health education |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages between 10 and 18 years
- had no history of receiving prior educational program
Key exclusion criteria (5 listed)
- Cardiac disease
- Pulmonary disease
- Liver function disorders
- Renal impairment
- Psychological disease
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 |
|---|---|---|
| Educational Program by Using Behavior Change Wheel ModelThe 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 | Behavioural | Study Group |
| Routine Health EducationParticipants in the control group received the routine health education and advice from nurses and healthcare providers working in the study settings | Behavioural | Control Group |
Primary outcome
Adolescents' behavior changes related to COM-B part of Behavior Change Wheel assessment form
Time frame: 3 months
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.
Reported assessment checklist of the second layer of Behavior Change Wheel
Time frame: 3 months
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.
Adolescent Alcohol and Drug Involvement Scale (AADIS)
Time frame: 3 Months
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).
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 24 Sep 2025.
- Background: PubMed 34711276Gilchrist 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.
- Background: PubMed 34828534Alarco-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.
- Individual participant dataSharing planned: No
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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.
Mohamed A Shehata, Professor study chair
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program by Using Behavior Change Wheel Model and Routine Health Education in people with Substance Abuse Problem, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 5 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 24 Sep 2025. 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 Egypt. 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?
Adolescents' behavior changes related to COM-B part of Behavior Change Wheel assessment form (time frame: 3 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?
On the ClinicalTrials.gov record for NCT07184164, which also lists 2 linked publications.
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 24 Sep 2025.