Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000224426
Ethics application status
Approved
Date submitted
3/02/2016
Date registered
18/02/2016
Date last updated
25/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Theory-based intervention for smoking cessation among Chinese middle school students
Scientific title
Developing and piloting a theory-based intervention for smoking cessation among Chinese middle school students
Secondary ID [1] 288340 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cigarette smoking 297319 0
Condition category
Condition code
Public Health 297519 297519 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims at (1) encouraging anti-smoking attitudes and beliefs, (2) fostering perceptions of normative support for anti-smoking behaviour, (3) increasing perceptions of control/self-efficacy to resist smoking, and (4) enhancing favourability of non-smoker images. Intervention sessions will be facilitated by a PhD student from Queensland University of Technology. For better understanding of local culture and school settings, this facilitator will be a registered school counsellor, with teaching and counselling experience in middle schools. To comply with Queensland regulations, the facilitator will also have a Positive Notice Blue Card (a safety check card that allows access to work with children). The intervention will be undertaken within middle school students during school hours. Approval of the form teacher of each participating class will be obtained before starting the intervention. All intervention-related activities will be conducted following the directions of the Principal or other senior staff regarding access to student participants and the location of testing. Testing will take place in an accessible area designated by the school principal or other administrative staff, in proximity to normal classroom activities. Assistance will be available from school staff when required. The facilitator will follow the required procedures for visitors to the school (e.g., registering with an ID card at the school gate).

The intervention will be a 1 x 40 minute session (equal to 1 class-time session) per week for 4 weeks. Each intervention session will address a different construct. Session one will be designed to encourage anti-smoking attitudes and beliefs. Session two will focus on fostering perceptions of normative support for anti-smoking behaviour. Session three will aim to increase perceptions of control/self-efficacy to resist smoking. Session four will target enhancing favourability of non-smoker images. Activities for the intervention will include class-based discussions, generic skill training (e.g., culturally appropriate refusal skills), and critical thinking over tobacco packaging and smoker images. At the conclusion of each session, participants will evaluate the program.
Intervention code [1] 293641 0
Prevention
Intervention code [2] 293642 0
Lifestyle
Intervention code [3] 293643 0
Behaviour
Comparator / control treatment
A no-treatment control group (a ‘wait-list control group’) is used but participants randomised to the control group will be offered the opportunity to receive the intervention material at the completion of the project.
Control group
Active

Outcomes
Primary outcome [1] 297075 0
Participants' smoking behaviour as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [1] 297075 0
At baseline and at 1 week and 6 months post intervention
Primary outcome [2] 297076 0
Participants' intentions to smoke as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [2] 297076 0
At baseline and at 1 week and 6 months post intervention
Primary outcome [3] 297267 0
Participants' willingness to smoke as measured by self-report through the use of a questionnaire developed by the researchers, using standard prototype willingness model items
Timepoint [3] 297267 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [1] 319987 0
Participants’ attitude toward smoking as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [1] 319987 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [2] 319988 0
Participants’ perception of normative support for smoking as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [2] 319988 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [3] 319989 0
Participants’ perception of control/self-efficacy toward smoking as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [3] 319989 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [4] 319990 0
Participants’ perception of smoker images as measured by self-report through the use of a questionnaire developed by the researchers, using standard prototype willingness model items
Timepoint [4] 319990 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [5] 319991 0
Participants’ general assertiveness as measured by self-report through the use of an adapted questionnaire developed by the Gambrill & Richey (1975)
Timepoint [5] 319991 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [6] 320536 0
Participants’ dispositions toward critical thinking as measured by self-report through the use of a questionnaire developed by Yeh (1999)
Timepoint [6] 320536 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [7] 320537 0
Participants’ ability of coping stress as measured by self-report through the use of a questionnaire developed by the researchers
Timepoint [7] 320537 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [8] 320538 0
Participants’ ability of decision making as measured by self-report through the use of a questionnaire developed by the researchers
Timepoint [8] 320538 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [9] 331069 0
Participants' ability of asking others to stop smoking in their presence as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [9] 331069 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [10] 331070 0
Participants' ability of refusing cigarettes from people with seniority as measured by self-report through the use of a questionnaire developed by the researchers, using standard theory of planned behaviour items
Timepoint [10] 331070 0
At baseline and at 1 week and 6 months post intervention
Secondary outcome [11] 331071 0
Participants' future intentions to smoke (when they reach 20 to 25 years and 40 to 45 years) as measured by self-report through the use of a questionnaire developed by the researchers
Timepoint [11] 331071 0
At baseline and at 1 week and 6 months post intervention

Eligibility
Key inclusion criteria
Eligibility criteria includes male and female 10th grade students from one public middle school and one private middle school in Kunming, China.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A convenience sample of schools will be recruited using a maximum variation sampling method to ensure participating schools range in social-demographic status and geographical location. Schools will be approached to participate by the study team using an information package delivered during face-to-face discussions, as this type of communication is more culturally appropriate in China. The information package will include background information about the study, a letter to the form teachers, questionnaire items, and the participant intervention content list. Consenting schools will be requested to identify suitable classes that will be accessible to the research team. Consent will be obtained from the Principals and form teachers. Consenting classes will then be randomised to the intervention or a wait-listed control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting schools will be randomised in a 1:1 ratio to the intervention or a wait-listed control group using a random number generator app on smart phone.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Information collected will be analysed quantitatively using repeated measure MANOVA and multiple regression analyses. Latent growth modelling will be also considered if any variable contains heterogeneity.
The proposed sample size is 160 participants. Prospective power calculation suggested that about 130 participants (65 per group) were required in order to operate a 3-time repeated measures MANOVA and multiple regression (alpha = .05, beta = .2; Tabachnick & Fidell, 2013). This sample size also ensured the utilization of latent growth curve models across time (Newsom, 2015). As a longitudinal study, we will recruit more in order to allow for attrition over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/02/2016
Actual
29/02/2016
Date of last participant enrolment
Anticipated
15/12/2016
Actual
10/03/2016
Date of last data collection
Anticipated
Actual
26/10/2016
Sample size
Target
160
Accrual to date
Final
207
Recruitment outside Australia
Country [1] 7534 0
China
State/province [1] 7534 0
Yunnan

Funding & Sponsors
Funding source category [1] 292704 0
University
Name [1] 292704 0
Queensland University of Technology
Country [1] 292704 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road, Kelvin Grove, Brisbane, Queensland 4059, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 291435 0
None
Name [1] 291435 0
Nil
Address [1] 291435 0
Nil
Country [1] 291435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294190 0
University Human Research Ethics Committee, Queensland University of Technology
Ethics committee address [1] 294190 0
Ethics committee country [1] 294190 0
Australia
Date submitted for ethics approval [1] 294190 0
14/11/2015
Approval date [1] 294190 0
24/12/2015
Ethics approval number [1] 294190 0
1500001027

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62798 0
Mr Xiang Zhao
Address 62798 0
OB404, Queensland University of Technology, Victoria Park Road, Kelvin Grove, Brisbane, Queensland 4059
Country 62798 0
Australia
Phone 62798 0
+61 731380045
Fax 62798 0
Email 62798 0
[email protected]
Contact person for public queries
Name 62799 0
Xiang Zhao
Address 62799 0
OB404, Queensland University of Technology, Victoria Park Road, Kelvin Grove, Brisbane, Queensland 4059
Country 62799 0
Australia
Phone 62799 0
+61 731380045
Fax 62799 0
Email 62799 0
[email protected]
Contact person for scientific queries
Name 62800 0
Xiang Zhao
Address 62800 0
OB404, Queensland University of Technology, Victoria Park Road, Kelvin Grove, Brisbane, Queensland 4059
Country 62800 0
Australia
Phone 62800 0
+61 731380045
Fax 62800 0
Email 62800 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.