ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

Addiction

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]