Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000465954
Ethics application status
Approved
Date submitted
12/12/2019
Date registered
9/04/2020
Date last updated
9/04/2020
Date data sharing statement initially provided
9/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Islamic-based program on adolescents smoking prevention
Scientific title
Effects of Islamic-based program using a family approaches on adolescents smoking prevention in Aceh, Indonesia.
Secondary ID [1] 299266 0
None
Universal Trial Number (UTN)
U1111-1240-2002
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Smoking behavior
 315605 0
Condition category
Condition code
Public Health 313895 313895 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: health based intervention program using family approach:
Intervention consist of 6 sessions, 90 minutes’ session per week for 6 weeks. The first session include introduction about smoking phenomena, the next session about prevalence of smoking and the smoking rules, the third session about health effect of smoking, the next session about stress managements, the fifth session about smoking refusal skills and the last session is closing and plan of action. The sessions will be delivered to adolescents by face-to-face activities in classroom, the intervention will be administered by health educators and psychiatric health nurses. The methods include lecture, demonstrations, discussion, storytelling and role playing. The media for intervention include booklet and manual guide sheet which are designed specifically for this study. At the end of each session, the researcher will hand the material with the same topic to student and ask them to give it to their parents as a guideline for planning of action at home.

Group 2: Islamic-based intervention program using family approach:
Intervention consist of 6 sessions, 90 minutes’ session per week for 6 weeks. The first session includes introduction about smoking phenomena among Muslim, the next session includes Islamic perspective about healthy living, the third session about Islamic perspective about smoking, the next session about stress managements based on Islamic teaching, the fifth session about smoking refusal skills using Islamic approach and the last session is closing and plan of action. All intervention for the student will be delivered face to face to face by health educators, psychiatric health nurses and Islamic scholars. The methods include lecture, demonstrations, discussion, storytelling and role playing. The media for intervention include booklet and manual guide sheet which are designed specifically for this study. At the end of each session, the researcher will hand the material with the same topic to student and ask them to give it to their parents as a guideline for planning of action at home.
The intervention adherence will be assessed by researcher using observation form which is designed specifically for this study.
Intervention code [1] 316352 0
Prevention
Intervention code [2] 316354 0
Behaviour
Comparator / control treatment
Group 3 (control group): there is no intervention for this group.
Control group
Active

Outcomes
Primary outcome [1] 322289 0
Knowledge about health effect of smoking will be assessed by self-report questionnaire, which is included 30 multiple choice questions. each question is presented in a multiple choice format with four possible options for each answer, with one point will be scored for each correct answer. The total score for this scale will range from 0 to 30 with higher scores representing greater knowledge. This questionnaire was designed specifically for this study.
Timepoint [1] 322289 0
Baseline, 2 weeks after completing intervention and 4 weeks after completing intervention.
Primary outcome [2] 322745 0
Attitudes toward smoking will be assessed by using self-report questionnaire which was designed specifically for this study. It includes 25 statements which are presented in a five-point Likert scale format, with responses ranging from 0 (strongly disagree) to 4 (strongly agree) for positively worded items, and 0 (strongly agree) to 4 (strongly disagree) for negatively worded items. scores are summed to obtain a total score for smoking attitude, which range from 0 to 100. A higher score indicate that the individual was more likely to smoke.
Timepoint [2] 322745 0
Baseline, 2 weeks after completing intervention and 4 weeks after completing intervention
Primary outcome [3] 322746 0
smoking intention will be assessed using questionnaire which were adapted from previous study. It include three questions, each question with five response categories, ranging from 0 for "certain not to smoke" to 4 for "certain to smoke". the three questions include, whether they would smoke tobacco next year, during senior high school and when older, or when over 50 years of age.
Timepoint [3] 322746 0
Baseline, 2 weeks after completing intervention and 4 weeks after completing intervention
Secondary outcome [1] 377983 0
Another primary outcome is smoking behavior. It will be assessed using three questions from previous study, including the number of cigarette smoked in the last seven days, in the last 30 days, and in the participants' lifetime.
To assess cigarette smoking frequency in the last seven days, response categories are ‘never tried a cigarette, not even one puff ’ (0), ‘one puff or two puffs’ (1), ‘just one cigarette’ (2) ‘two cigarettes’ (3), and ‘three to five cigarettes’ (4). For assessing the frequency of cigarettes smoked in the last month, we will use the following response categories: ‘I did not smoke cigarettes during the past 30 days’ (0), ‘less than one cigarette per day’ (1), ‘one cigarette per day’ (2), ‘two to five cigarettes per day’ (3), ‘six to ten cigarettes per day’ (4), ‘11 to 20 cigarettes per day’ (5), ‘more than 20 cigarettes per day’ (6). Finally, for assessing frequency of lifetime cigarette smoking, the responses include ‘I did not smoke any cigarettes’ (0), ‘less than one cigarette’ (1), ‘one cigarette’ (2), ‘two to five cigarettes’ (3), ‘six to ten cigarettes’ (4), ‘11 to 20 cigarettes’ (5), ‘21 to 60 cigarettes’ (6), ‘61 to 100 cigarettes’ (7), and ‘more than 100 cigarettes’ (8). higher score indicate higher frequency of smoking.
Timepoint [1] 377983 0
Baseline, 2 weeks after completing intervention and 4 weeks after completing intervention

Eligibility
Key inclusion criteria
Adolescents in Junior High School
Minimum age
11 Years
Maximum age
14 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The adolescents who could not provide written informed consent.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using T-Test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2020
Actual
Date of last participant enrolment
Anticipated
29/06/2020
Actual
Date of last data collection
Anticipated
21/09/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 22182 0
Indonesia
State/province [1] 22182 0
Aceh

Funding & Sponsors
Funding source category [1] 304532 0
University
Name [1] 304532 0
Universitas Syiah Kuala
Country [1] 304532 0
Indonesia
Primary sponsor type
University
Name
universitas Syiah Kuala. Banda Aceh, Indonesia
Address
Jl. Tgk. Abdur Rauf, Darussalam, Banda Aceh, Aceh, Indonesia, Post code : 23111,
Email. www.unsyiah.ac.id
Country
Indonesia
Secondary sponsor category [1] 303921 0
None
Name [1] 303921 0
None
Address [1] 303921 0
None
Country [1] 303921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304318 0
Faculty of Nursing Ethics Committee
Ethics committee address [1] 304318 0
Ethics committee country [1] 304318 0
Indonesia
Date submitted for ethics approval [1] 304318 0
14/12/2018
Approval date [1] 304318 0
26/12/2018
Ethics approval number [1] 304318 0
113003101118

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

Contacts
Principal investigator
Name 96518 0
Mrs Ns. Fithria, MNS
Address 96518 0
Ns. Fithria, MNS
Jl. Tgk. Tanoh Abee, Fakultas Keperawatan, Universitas syiah Kuala, Darussalam, Banda Aceh, Provinsi Aceh, Indonesia, postcode: 23111.
Country 96518 0
Indonesia
Phone 96518 0
+6281377254212
Fax 96518 0
+626517555249
Email 96518 0
[email protected]
Contact person for public queries
Name 96519 0
Ns. Fithria, MNS
Address 96519 0
Ns. Fithria, MNS
Jl. Tgk. Tanoh Abee, Fakultas Keperawatan, Universitas syiah Kuala, Darussalam, Banda Aceh, Provinsi Aceh, Indonesia, postcode: 23111
Country 96519 0
Indonesia
Phone 96519 0
+6281377254212
Fax 96519 0
+626517555249
Email 96519 0
[email protected]
Contact person for scientific queries
Name 96520 0
Ns. Fithria, MNS
Address 96520 0
Ns. Fithria, MNS
Jl. Tgk. Tanoh Abee, Fakultas Keperawatan, Universitas syiah Kuala, Darussalam, Banda Aceh, Provinsi Aceh, Indonesia, postcode: 23111
Country 96520 0
Indonesia
Phone 96520 0
+6281377254212
Fax 96520 0
+626517555249
Email 96520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


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.