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Trial registered on ANZCTR


Registration number
ACTRN12616000077460
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
22/01/2016
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Don’t let alcohol be in control! Can we teach adolescents to gain control over alcohol-related impulses and thoughts?
Scientific title
A cluster randomised controlled trial evaluating the efficacy of a brief mindfulness-enhanced wellbeing intervention for decreasing alcohol use and alcohol-related problems in adolescents
Secondary ID [1] 288378 0
Nil
Universal Trial Number (UTN)
U1111-1178-7363
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 297378 0
Condition category
Condition code
Mental Health 297563 297563 0 0
Addiction
Public Health 297592 297592 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two interventions will be compared to each other and to an assessment-only control. The interventions will involve 3 x 90-min group sessions, delivered one week apart. The Mindfulness-enhanced cognitive-behavioural condition (M-CBT) involves teaching participants 1.) Several mindfulness meditations (MM); 2.) how to identify and cope with dysfunctional cognitions. The standard cognitive-behavioural condition (CBT) will be the same as M-CBT, except students will be taught progressive muscle relaxation (PMR) instead of MM.

Session 1 will involve psychoeducation on the physiology of stress and negative emotions and common maladaptive coping behaviours (aggression, alcohol use). MM or PMR will be introduced as an adaptive coping strategy for stress and participants will be led through MM/PMR and asked to practice it at least once before the next session. The MM basic meditation exercise embodies the central features of mindfulness practice: intentionally paying attention to moment-by- moment experience (impulses, thoughts) with an attitude of acceptance (Feldman et al., 2010; Segal, Teasdale, Williams, & Gemar, 2002). The PMR basic meditation exercise consists of two steps applied systematically to the whole body: directing students to tense a particular muscle and then asking them to release this tension and focus on relaxing the muscle (Nickel et al., 2005).

Session 2 will commence with a short MM/PMR practice followed by a review of home practice of techniques, including identification of barriers to implementing skill practice. Beck's (1976) cognitive model will be introduced to explain the role of irrational thoughts in causing stress and maladaptive coping. Participants will analyse a personal stressful experience and use the model to identify cognitive, behavioural and physiological responses and be taught how to identify and objectively evaluate irrational thoughts leading to stress. Participants will be asked to practice identifying and objectively evaluating irrational thoughts at home, and continue practicing MM/PMR as well.

Session 3 will commence with a short MM/PMR practice followed by a review of at-home practice. Participants will be reminded of Beck’s cognitive model. They will then be guided through the application of the cognitive model to a previous (or hypothetical, if there are none) situation where they felt (or might feel) social/peer pressure to consume alcohol. Irrational thoughts concerning alcohol effects will be identified and challenged (e.g., “I need a drink to fit in and have fun”). This section will also involve psychoeducation around alcohol refusal self-efficacy (confidence in your ability to refuse an alcohol offer).

All intervention procedures have been previously administered to adolescents with no negative outcomes reported (e.g., Biegel, Brown, Shapiro, & Schubert, 2009; Conrod, Castellanos-Ryan, & Mackie, 2011). All are brief forms of therapeutic interventions previously shown in adults to enhance psychological health (e.g., Butler, Chapman, Forman, & Beck, 2006; Khoury et al., 2013).

Participants in the intervention conditions will receive fortnightly SMS support messages from post-intervention to 6-month follow-up. SMS will be sent at random times/days, but not during school hours, before 8am or after 10pm. Each SMS will aim to reinforce learning or encourage skill practice.

In addition to these support SMSs, fortnightly assessment messages (alternate week to support messages) will also be sent linking them to a Qualtrics question asking participants to rate on a 10-point scale (1 = no stress to 10 = extreme stress) how stressed they have been over the past 14 days and if they have consumed any alcohol during this period. Participants scoring above 5 on the stress scale, or reporting recent alcohol use, will receive weekly SMS support over the following fortnight (i.e., double dose). Participant responses to each SMS will be rewarded with the allocation of one voucher for a prize lottery to win an iPad. Correct answers to content questions will receive 3 vouchers. SMS replies will be free of charge to participants. Participants in the Assessment Only Control Condition will also receive vouchers for each completed assessment that will be linked to a separate lottery for an iPad (i.e., no prize draw disadvantage due to lack of SMS contact). Any participants scoring >8 out of 10 on the stress scale will also be sent an SMS containing the contact details for Kids Helpline, a free, private and confidential, telephone and online counselling service specifically for young people aged between 5 and 25.

The sessions will be delivered by a fully registered clinical psychologist and/or provisionally registered psychologists from the clinical or applied masters of psychology programs at the University of Queensland who have received training from a clinical psychologist in the delivery of the program. Due to the anonymity of the students, we will not be able to link attendance from a register of attendance at sessions to their unique identification code. Thus we will not be monitoring adherence.
Intervention code [1] 293680 0
Prevention
Intervention code [2] 293681 0
Behaviour
Intervention code [3] 293682 0
Treatment: Other
Comparator / control treatment
Two interventions (one of which is an active control) will be compared to each other and to an assessment-only control. The interventions will involve 3 x 90-min group sessions, delivered one week apart. The active control group will be the same as M-CBT, except students will be taught progressive muscle relaxation (PMR) instead of MM. The intervention procedures for the active control are described above.

Participants allocated to the assessment-only control condition will complete the baseline and follow-up assessments and will receive no intervention during the trial. However, they will be offered the most effective of the two active interventions after the 6-month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 297118 0
Growth in alcohol use/problems over the assessment time-points as measured by the Rutgers Alcohol Problems Index and the Alcohol Use Identification Test.
Timepoint [1] 297118 0
Immediately post intervention, 3-months post, and 6-months post
Secondary outcome [1] 320057 0
Change in dysfunctional cognition over the follow-up time points, as measured by the Children's Automatic Thoughts Scale, the Drinking Expectancy Questionnaire - Adolescent version, and the Drinking Refusal Self-Efficacy Questionnaire - Revised Adolescent version
Timepoint [1] 320057 0
Immediately post intervention, 3-months post, and 6-months post
Secondary outcome [2] 320058 0
Change in impulse control over the follow-up time points, as measured by the Barratt Impulsiveness Scale-Brief, the Short form Sensitivity to Reward scale, and the Mindful Attention Awareness Scale-Adolescent
Timepoint [2] 320058 0
Immediately post intervention, 3-months post, and 6-months post
Secondary outcome [3] 320059 0
Change in mood and wellbeing over the follow-up time points, as measured by the Strengths and Difficulties Questionnaire
Timepoint [3] 320059 0
Immediately post intervention, 3-months post, and 6-months post
Secondary outcome [4] 320060 0
Change in coping and emotion regulation over the follow-up time points, as measured by the Emotion Regulation Questionnaire for Children and Adolescents and the Primary Engagement Coping subscale of the Response to Stress Questionnaire.
Timepoint [4] 320060 0
Immediately post intervention, 3-months post, and 6-months post

Eligibility
Key inclusion criteria
Enrolled year 9 or year 10 students in South-East Queensland
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Students will be recruited at the school level and then groups will be randomly allocated by class within the school (cluster-randomisation).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The relationship between intervention group and effect on cognitive, behaviour, and alcohol outcomes will be tested using Structural Equation Modelling. Moderating effects will be investigated using multiple group invariance testing. Hypotheses concerning differential mediation effects will be tested by comparing nested mediation and non-mediation models, and the statistical significance of indirect effects.

Sample size requirements were determined for all primary analyses, including the mediation models. Based on model degrees of freedom, number of assessment points, and requirements of mediation testing, a total sample size of 367 is required to achieve power of .80. We conservatively assume a 20% attrition rate and seek to recruit 441 participants at baseline (n = 147 per condition). Thus, a conservative estimate of the number of schools required to participate is 8 (3 classes of 20 students from 8 schools = 480 students). While average class sizes in Queensland are larger than 20 students (approx. 28 students/class according to the Education Queensland 2014 report), we are allowing for the possibility of refusal of consent from parents/guardians or students.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292736 0
Government body
Name [1] 292736 0
Australian Postgraduate Award - Department of Education and Training
Address [1] 292736 0
Department of Education and Training
50 Marcus Clarke Street,
Canberra ACT 2600
Country [1] 292736 0
Australia
Primary sponsor type
University
Name
Centre for Youth Substance Abuse Research, University of Queensland
Address
Center for Youth Substance Abuse Research
The University of Queensland
31 Upland Rd, St Lucia,
Brisbane, QLD, 4067
Australia
Country
Australia
Secondary sponsor category [1] 291463 0
None
Name [1] 291463 0
Address [1] 291463 0
Country [1] 291463 0
Other collaborator category [1] 278781 0
Individual
Name [1] 278781 0
Dr Matthew Gullo
Address [1] 278781 0
Center for Youth Substance Abuse Research
The University of Queensland
31 Upland Rd, St Lucia,
Brisbane, QLD, 4067
Australia
Country [1] 278781 0
Australia
Other collaborator category [2] 278782 0
Individual
Name [2] 278782 0
Professor Jason Connor
Address [2] 278782 0
Center for Youth Substance Abuse Research
The University of Queensland
31 Upland Rd, St Lucia,
Brisbane, QLD, 4067
Australia
Country [2] 278782 0
Australia
Other collaborator category [3] 278783 0
Individual
Name [3] 278783 0
Dr Jeanie Sheffield
Address [3] 278783 0
School of Psychology
The University of Queensland
St Lucia, Brisbane, QLD, 4067
Country [3] 278783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294217 0
University of Queensland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 294217 0
University of Queensland
St Lucia, Brisbane, QLD, 4067
Ethics committee country [1] 294217 0
Australia
Date submitted for ethics approval [1] 294217 0
04/06/2015
Approval date [1] 294217 0
19/10/2015
Ethics approval number [1] 294217 0
#2015000875
Ethics committee name [2] 294218 0
Brisbane Catholic Education
Ethics committee address [2] 294218 0
243 Gladstone Rd,
Dutton Park, QLD 4102
Ethics committee country [2] 294218 0
Australia
Date submitted for ethics approval [2] 294218 0
02/11/2015
Approval date [2] 294218 0
09/12/2015
Ethics approval number [2] 294218 0
196

Summary
Brief summary
In this study we aim to enhance adolescent prevention programs through a theoretically-driven application of mindfulness meditation (MM) that will reduce alcohol use and behaviour problems by directly targeting impulse control.

This study will be a cluster randomised controlled trial comparing a MM enhanced cognitive behavioural therapy (CBT) condition with a CBT with progressive muscle relation condition and a non-intervention control condition. These interventions will be delivered at 3 time-points and participants will be followed up at several time points during their schooling years.

We hypothesise that the both the MM enhanced CBT and the standard CBT conditions will produce superior outcomes to the assessment-only control and that the MM enhanced CBT condition will result in superior outcomes to the standard CBT condition.
Trial website
http://mindfulcontrol.com/
http://relaxandcontrol.com/
Trial related presentations / publications
Public notes
Attachments [1] 722 722 0 0
Attachments [2] 723 723 0 0

Contacts
Principal investigator
Name 62926 0
Ms Kiri Patton
Address 62926 0
Centre for Youth Substance Abuse Research
The University of Queensland
K Floor
Mental Health Centre
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 62926 0
Australia
Phone 62926 0
+61 498 636 235
Fax 62926 0
Email 62926 0
kiri.patton@uqconnect.edu.au
Contact person for public queries
Name 62927 0
Prof Jason Connor
Address 62927 0
Center for Youth Substance Abuse Research
The University of Queensland
31 Upland Rd, St Lucia,
Brisbane, QLD, 4067
Australia
Country 62927 0
Australia
Phone 62927 0
+61 7 3343 2535
Fax 62927 0
Email 62927 0
jason.connor@uq.edu.au
Contact person for scientific queries
Name 62928 0
Dr Matthew Gullo
Address 62928 0
Center for Youth Substance Abuse Research
The University of Queensland
31 Upland Rd, St Lucia,
Brisbane, QLD, 4067
Australia
Country 62928 0
Australia
Phone 62928 0
+61 7 3443 2537
Fax 62928 0
Email 62928 0
m.gullo@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary