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Trial registered on ANZCTR


Registration number
ACTRN12615000302550
Ethics application status
Approved
Date submitted
12/03/2015
Date registered
1/04/2015
Date last updated
1/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
My teenager and alcohol: What have I got to do with it? Evaluating a brief online program for parents.
Scientific title
Comparing the effects of a tailored web-based parenting program (Parenting Strategies) to a non-tailored, information-only control intervention, on parental alcohol use and modelling of alcohol-related behaviours and attitudes: A pilot randomized controlled trial
Secondary ID [1] 286231 0
Nil
Universal Trial Number (UTN)
U1111-1167-4452
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 294278 0
Alcohol-related behaviours
 294334 0
Condition category
Condition code
Public Health 294599 294599 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents in the intervention group will receive an individually-tailored feedback report on their current drinking and the alcohol-related attitudes and behaviours based on their responses to a brief online survey (adapted from the Parenting Strategies: preventing adolescent alcohol misuse parent survey; Yap, Jorm & Lubman (2015). What are parents doing to reduce adolescent alcohol misuse? Evaluating concordance with parenting guidelines for adolescent alcohol use. BMC Public Health, 15:114). The feedback report highlights where parents are doing well (i.e., concordant with the Guidelines), as well as ways they can improve in specific behaviours that are not currently concordant with the Guidelines (based on their responses to corresponding survey questions about these behaviours). The messages in the feedback report are brief, with practical strategies provided in dot point form, and are designed to motivate behaviour change. The feedback report is presented on the website immediately after parents submit their baseline assessment and are randomly allocated to the intervention group. They then receive the Modelling module of the Parenting Strategies Program (www.parentingstrategies.net), which provides specific tips and trouble-shooting ideas to help parents modify their attitudes and behaviours regarding alcohol so as to be more in concordance with the Parenting Guidelines for Adolescent Alcohol Use. This online module takes about 20 minutes to complete. Parents are invited to complete the module immediately after they have completed their baseline survey and received their feedback report. Thereafter their access to the module will remain open indefinitely.
Parents also receive a copy of their feedback report and the Parenting Guidelines for Adolescent Alcohol Use via email.
Intervention code [1] 291258 0
Behaviour
Intervention code [2] 291265 0
Lifestyle
Comparator / control treatment
Upon completing a short online survey (same survey as intervention group), participants randomly allocated to the control group will receive a non-tailored summary of the Australian Guidelines for Reducing Health Risks from Drinking Alcohol (National Health and Medical Research Council, 2009) for a healthy adult and a young person under 18 years of age. The feedback report is presented on the website immediately after parents submit their baseline assessment and are randomly allocated to the control group. Parents also receive a copy of their feedback report via email.
Control group
Active

Outcomes
Primary outcome [1] 294381 0
Parental alcohol consumption as measured by the total score from the 3 Consumption questions from the WHO Alcohol Use Disorders Identification Test (AUDIT-C). The third question was adapted from "6 or more drinks' to '4 or more drinks' to align it to the NHMRC Guidelines recommendation that drinking no more than four standard drinks on a single occasion will help reduce the risk of alcohol-related injury.
Timepoint [1] 294381 0
This will be measured at baseline, 1 month, 3 months and again at 12 months after randomisation.
Primary outcome [2] 294638 0
7 parental modelling questions developed to assess the behaviours regarding alcohol that parents are modelling to their adolescent, against the Parenting Guidelines for Adolescent Alcohol Use.
Timepoint [2] 294638 0
This will be measured at baseline, 1 month, 3 months and again at 12 months after randomisation.
Secondary outcome [1] 313164 0
Adolescent Intention to Drink Alcohol as measured by 2 questions:
For the next two questions, please answer, Yes, No, or Maybe.
1. Do you think you would drink alcohol:
a) When you are aged between 15-17 years old?
b) After you turn 18?
Timepoint [1] 313164 0
This will be measured at 3 months and again at 12 months after the adolescent's parent had completed their baseline survey.

Eligibility
Key inclusion criteria
1. Parents/guardians and adolescents living in the state of Victoria.
2. Parents/guardians and adolescents proficient in English.
3. Adolescents who have parental consent to participate in the study; and who provide verbal assent to participate.
Note: parents can still take part without their child.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parents/guardians and adolescents whose primary residence is outside the state of Victoria.
2. Parents/guardians and adolescents not proficient in English.
3. Adolescents who do not have parental consent to participate in the study; or who do not provide verbal assent to participate. Note: parents can still take part without their child.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When parents submit their baseline assessment on the trial website, the website will generate an automated random allocation sequence to allocate parent-adolescent dyads to either the control or intervention group. Parents will find out which group they have been assigned to when they receive their feedback report immediately after submitting their baseline assessment. As such, allocation is concealed from both participants and researchers prior to assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial website is programmed to run a random allocation sequence to allocate parent-adolescent dyads to either the control or intervention group, as soon as parents submit their baseline assessment online.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
"The people administering the treatment/s" are "masked" because the interventions are programmed to be fully automated by the trial website, which cannot be biased.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on an expected medium effect size, we need 64 per group = 128 parents + adolescents. Allowing for 15% attrition, we need to recruit 150 parent-adolescent dyads at baseline.

Required sample size:
Based on a power analysis, for a repeated-measures design with a power of 0.80, an expected medium effect size, and alpha level of 0.05, a sample size of 64 per group = 128 parents + adolescents dyads is required.
Allowing for an attrition rate of approximately 15%, we aim to recruit 150 parent-adolescent dyads (75 dyads per group) at baseline.

Data analysis:
The main analyses will be intent-to-treat. To assess group differences in changes in parental drinking and modelling (primary outcomes) across timepoints (baseline, 1 month, 3 month and 12-month follow-up), a series of mixed effects analyses of covariance (ANCOVAs) will be conducted. Adolescent age and gender will be used as covariates.
Little's MCAR (missing completely at random) test will be used to analyse the extent and pattern of missing data.

To assess group differences in adolescent intention to drink at 3 month and 12 month follow up (secondary outcome), a Discriminant Factor Analysis will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/04/2015
Actual
Date of last participant enrolment
Anticipated
13/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290801 0
University
Name [1] 290801 0
Monash University
Country [1] 290801 0
Australia
Primary sponsor type
Individual
Name
Marie Yap
Address
Building 17
18 Innovation Walk
Monash University
Clayton, 3800
Victoria
Country
Australia
Secondary sponsor category [1] 289482 0
None
Name [1] 289482 0
Address [1] 289482 0
Country [1] 289482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292427 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292427 0
Ethics committee country [1] 292427 0
Australia
Date submitted for ethics approval [1] 292427 0
15/12/2014
Approval date [1] 292427 0
02/03/2015
Ethics approval number [1] 292427 0
2014002021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 349 349 0 0
/AnzctrAttachments/368034-2014002021 MUHREC Approval.pdf

Contacts
Principal investigator
Name 55194 0
Dr Marie Yap
Address 55194 0
School of Psychological Sciences
Bld 17, 18 Innovation Walk
Monash University
Clayton, Victoria 3800
Country 55194 0
Australia
Phone 55194 0
+613 9905 0723
Fax 55194 0
Email 55194 0
marie.yap@monash.edu
Contact person for public queries
Name 55195 0
Owen Broadley
Address 55195 0
School of Psychological Sciences
Bld 17, 18 Innovation Walk
Monash University
Clayton, Victoria 3800
Country 55195 0
Australia
Phone 55195 0
+613 9905 1250
Fax 55195 0
Email 55195 0
obro2@student.monash.edu
Contact person for scientific queries
Name 55196 0
Marie Yap
Address 55196 0
School of Psychological Sciences
Bld 17, 18 Innovation Walk
Monash University
Clayton, Victoria 3800
Country 55196 0
Australia
Phone 55196 0
+613 9905 0723
Fax 55196 0
Email 55196 0
marie.yap@monash.edu

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.