Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000905763p
Ethics application status
Not yet submitted
Date submitted
22/06/2022
Date registered
24/06/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
24/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a text-message based intervention targeting parents on adolescent e-cigarette use
Scientific title
A randomised controlled trial to examine the potential effect of a text-message based intervention targeting parents on adolescent e-cigarette use
Secondary ID [1] 307414 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is being replaced by trial ACTRN12623000079640.

Health condition
Health condition(s) or problem(s) studied:
E-cigarette use 326750 0
Condition category
Condition code
Public Health 323980 323980 0 0
Health promotion/education
Mental Health 323981 323981 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial design will be used to test the effectiveness of a theory-based intervention to prevent adolescent e-cigarette use among parents of adolescents aged 14 to 17 years in New South Wales, Australia.

Parents allocated to the intervention group will receive a 12-week theory-based intervention to prevent adolescent e-cigarette use. The intervention will consist of a library of text messages addressing adolescent e-cigarette use developed following extensive consultation with parents and adolescents via focus groups, semi-structured interviews and online surveys, in addition to consultation with researchers and experts from the field of e-cigarettes and tobacco. The messages target constructs within the Theory of Planned Behaviour (i.e. attitudes, subjective norms and perceived behavioural control), a theory frequently employed to guide the development of text-message based interventions to prevent and address adolescent tobacco use. Messages will be sent to parents to target factors (I.e. barriers and enablers) associated with adolescent e-cigarette use, aligned to each of the Theory of Planned Behaviour constructs.

Parents allocated to the intervention group will receive two plain text messages (i.e. do not contain external links) per week for one school term (12 weeks). The length of each text message will be 1-2 sentences. Adherence to the intervention will be monitored via analytics (e.g. read receipts) automatically captured by the text-message program used to disseminate the messages to parents.
Intervention code [1] 323850 0
Prevention
Comparator / control treatment
Parents allocated to the control group will receive the text-messages following the collection of all outcome measures (i.e. at 6 months post-intervention commencement).
Control group
Active

Outcomes
Primary outcome [1] 331779 0
Adolescent intentions to use e-cigarettes will be assessed in one online or telephone survey conducted by a trained research assistant. Validated survey items outlined by O’Brien et al. (2022) will be used to assess adolescent intentions to use e-cigarettes.
Timepoint [1] 331779 0
Assessed at follow-up (12 weeks and 6-months post-intervention commencement).
Secondary outcome [1] 411099 0
Adolescent ever-use of e-cigarettes, defined as any lifetime use of e-cigarettes, will be assessed via one online or telephone survey conducted by a trained research assistant. To aid comparisons of the effect of e-cigarette policies and interventions, Pearson et al. (2018) recommends for eight core constructs of e-cigarette use to be assessed. As such, adolescents that report e-cigarette ever-use at follow-up will be asked additional survey items (recommended by Pearson et al. (2018)) to assess the remaining constructs, including: frequency of e-cigarette use; former daily use; relative perceived harm; device type; primary flavour preference; presence of nicotine within the e-cigarettes; and primary reason for use.
Timepoint [1] 411099 0
Assessed at follow-up (12 weeks and 6 months post-intervention commencement).
Secondary outcome [2] 411100 0
Acceptability of the text-message intervention (defined as the perception amongst parents that the intervention is agreeable, palatable or satisfactory) will be assessed in an online or telephone survey with parents allocated to the intervention group. Survey items to assess acceptability will be based on validated items developed by Weiner et al. (2017).
Timepoint [2] 411100 0
Assessed at follow-up (12 weeks post-intervention commencement).
Secondary outcome [3] 411101 0
Appropriateness of the text-message intervention (defined as the perceived fit, relevance or compatibility of the intervention for parents) will be assessed in an online or telephone survey with parents allocated to the intervention group. Survey items to assess appropriateness will be based on validated items developed by Weiner et al. (2017).
Timepoint [3] 411101 0
Assessed at follow-up (12 weeks post-intervention commencement),

Eligibility
Key inclusion criteria
Parents of adolescents aged between 14 to 17 years, located within New South Wales, Australia, who have never used e-cigarettes will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Parent-adolescent dyads will be recruited via multiple methods, including promotions through schools and social media (e.g. Facebook and Instagram) using paid advertising targeting adolescents. Potentially eligible parents will be encouraged to complete an Expression of Interest online form accessible via the targeted advertisements to indicate their consent to participate in all study components, including the data collection for their child. A research assistant, blind to group allocation will conduct a short telephone call to confirm participant eligibility. Following recruitment and confirmation of eligibility, an independent statistician will randomly allocate the parent-adolescent dyads to either the intervention or control condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following recruitment, an independent statistician will randomise the parent-adolescent dyads, using a computerised random number function, stratified by the geographic and socio-economic location in a 1:1 (intervention: control) ratio using random block sizes of between 2-6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe parent characteristics, acceptability and appropriateness of the text-message intervention.

Analyses of trial outcomes will be undertaken under an intention to treat framework. For the primary trial outcome (adolescent intentions to use e-cigarettes) between group differences will be assessed using logistic regression. The model will include a term for treatment group (intervention vs control) and pre-specified covariates prognostic of the outcome. We will employ multiple imputation for any missing data in the event that participants withdraw from the study and request that their data is not used. All statistical tests will be 2 tailed with alpha of 0.05

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This trial is being replaced by trial ACTRN12623000079640.
Date of first participant enrolment
Anticipated
31/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311690 0
University
Name [1] 311690 0
University of Newcastle
Country [1] 311690 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 313145 0
Government body
Name [1] 313145 0
Hunter New England Population Health
Address [1] 313145 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 313145 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311143 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 311143 0
University Drive, Callaghan, NSW, 2308
Ethics committee country [1] 311143 0
Australia
Date submitted for ethics approval [1] 311143 0
01/10/2022
Approval date [1] 311143 0
Ethics approval number [1] 311143 0

Summary
Brief summary
Previous research indicates that text-message based programmes can be an effective public health approach to improve adolescent health behaviours, including tobacco use, thus may have promise as an approach to influence adolescent e-cigarette behaviours. We aim to conduct a randomised controlled trial to examine the potential effect of a text-message program targeting parents to prevent adolescent e-cigarette use. Over 12 weeks, parents of adolescents will receive text messages designed to address the factors identified that increase the risk of adolescent use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120094 0
Prof Luke Wolfenden
Address 120094 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 120094 0
Australia
Phone 120094 0
+61 2 49246472
Fax 120094 0
Email 120094 0
luke.wolfenden@health.nsw.gov.au
Contact person for public queries
Name 120095 0
Dr Courtney Barnes
Address 120095 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 120095 0
Australia
Phone 120095 0
+61 2 49246678
Fax 120095 0
Email 120095 0
courtney.barnes@health.nsw.gov.au
Contact person for scientific queries
Name 120096 0
Dr Courtney Barnes
Address 120096 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 120096 0
Australia
Phone 120096 0
+61 2 49246678
Fax 120096 0
Email 120096 0
courtney.barnes@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data for this trial will be available as ethics approval does not cover this. If a request for individual participant data is made and appropriate ethics approvals obtained, such data may be made available in the future.


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.