AsthmaPhase 2TAJPlusNCT01938976
Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels and Smoking Behavior Among Early Adolescents in Jordan
A Phase 2 study testing TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge in people with Asthma and Tobacco, run by University of Technology, Sydney.
Trial summary
Study Hypotheses: 1. adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone. 2. Read more about this study
- Who is it for?
- Ages 11 to 14 years, men only
- What is being tested?
- TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 815 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to May 2013
- Phase
- Phase 2
- 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 11 to 14 years
- Men only
- No healthy volunteers
- Child
Inclusion Criteria: students in grades 7 and 8 in Irbid city high schools, can speak and read in both Arabic and English, obtain parental agreement, attend regular school.
-
Exclusion Criteria:students with other chronic diseases (rather than asthma),
-
About this study
Official title: Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels, Nicotine Dependence, and Smoking Behavior Among Early Adolescents in Jordan
Study Hypotheses:
- adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone.
- adolescents with asthma in intervention schools who are given Triple A program plus ASP will show less asthma symptoms and better control than those in the control schools who are given Triple A alone.
- adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide (CO) in their breath than those who are not active or passive smokers.
- there is a positive correlation between self-report questions regarding student smoking status and levels of CO in their breath
- Conditions
- Asthma, Tobacco, Waterpipe, Cigarettes
- Being tested
- TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge
- Keywords
- Asthma, Tobacco, Waterpipe, Cigarettes, Adolescents, Peer education, Jordan
- Medical subject headings
- Asthma, Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledgeBehavioural
Also called Triple A in Jordan (TAJ)
Its is a school-based peer-led asthma and smoking prevention program that aims at improving asthma control and lowering nicotine dependence among smokers.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Asthma Action | Experimental | Adolescent Asthma Action in Jordan (TAJ) Plus the added class smoke free pledge will be implemented in high schools in Jordan and will be compared to the TAJ alone for its efficacy in decreasing smoking rates, lowering CO1 levela and nicotine dependence. Receives: Behavioral: TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge |
| TAJ | Experimental | TAJ Plus the class smoke free pledge will be implemented in high schools in Jordan and compared to TAJ alone Receives: Behavioral: TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
nicotine dependence level
Self-administered nicotine dependence scale will be used in order to measure nicotine dependence level for adolescent smokers and passive smokers
Measured: 3 months
Asthma Contol level
The pictorial version of the asthma control test will be measured for adolescents with asthma and recent wheezing
Measured: 3 months
Secondary outcomes (2)
Carbon monoxide (CO) breath test
CO levels will be tested in adolescents' breath
Measured: 3 months
knowledge about health effects of cigarettee smoking
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 posted10 Sep 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Technology, Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Dr. NIHAYA AL-SHEYAB, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938976
- Sponsor's protocol ID
- 96/2012
- Acronym
- TAJPlus
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels, Nicotine Dependence, and Smoking Behavior Among Early Adolescents in Jordan
- ClinicalTrials.gov ID
- NCT01938976
- Acronym / sponsor ID
- TAJPlus / 96/2012
- Conditions
- Asthma, Tobacco, Waterpipe, Cigarettes
- Keywords
- Asthma, Tobacco, Waterpipe, Cigarettes, Adolescents, Peer education, Jordan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- University of Technology, SydneyUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Sep 2013 (estimated)
- 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.
Study Hypotheses:
- adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone.
- adolescents with asthma in intervention schools who are given Triple A program plus ASP will show less asthma symptoms and better control than those in the control schools who are given Triple A alone.
- adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide (CO) in their breath than those who are not active or passive smokers.
- there is a positive correlation between self-report questions regarding student smoking status and levels of CO in their breath
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent Asthma Action | Experimental | Behavioral: TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledgeAdolescent Asthma Action in Jordan (TAJ) Plus the added class smoke free pledge will be implemented in high schools in Jordan and will be compared to the TAJ alone for its efficacy in decreasing smoking rates, lowering CO1 levela and nicotine dependence. |
| TAJ | Experimental | Behavioral: TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledgeTAJ Plus the class smoke free pledge will be implemented in high schools in Jordan and compared to TAJ alone |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledgeAlso: Triple A in Jordan (TAJ)Its is a school-based peer-led asthma and smoking prevention program that aims at improving asthma control and lowering nicotine dependence among smokers. | Behavioural | Adolescent Asthma Action, TAJ |
Primary outcome
nicotine dependence level
Time frame: 3 months
Self-administered nicotine dependence scale will be used in order to measure nicotine dependence level for adolescent smokers and passive smokers
Asthma Contol level
Time frame: 3 months
The pictorial version of the asthma control test will be measured for adolescents with asthma and recent wheezing
2 secondary outcomes
Carbon monoxide (CO) breath test
Time frame: 3 months
knowledge about health effects of cigarettee smoking
Time frame: 3 months
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 10 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge in people with Asthma and Tobacco, run by University of Technology, Sydney.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
nicotine dependence level (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.