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Trial registered on ANZCTR


Registration number
ACTRN12613000108718
Ethics application status
Approved
Date submitted
27/01/2013
Date registered
29/01/2013
Date last updated
22/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief telephone interventions for reducing future alcohol use and related harm in young people accessing emergency departments
Scientific title
Brief telephone delivered personality-targeted versus standard motivational interviewing for for reducing future alcohol use and related harm in young people accessing emergency departments
Secondary ID [1] 281844 0
Nil
Universal Trial Number (UTN)
U1111-1138-9460
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol abuse 288205 0
Condition category
Condition code
Mental Health 288573 288573 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomized to receive a 1x30 minute telephone session of Assessment Feedback and Information (AF), 2x30 minute telephone sessions of Quik-Fix motivational interviewing (MI) or 2x30 minute telephone sessions of a Personality-Targeted Intervention (PI). The two telephone sessions in the MI and PI groups occur one week apart.

i) Quik-Fix MI: The Quik-Fix MI comprises a number of components. First AF delivered in a MI style (i.e. empathically, amplifying the person’s own concerns). MI about alcohol is then provided to: (a) build readiness and commitment to make a change (including pros and cons of current use and change), (b) negotiate change goals, and (c) develop a plan for change. Individuals do not progress to Step b or c unless they are ready to change (i.e. rating > 7/10 on importance of change & confidence to change likert scales). Homework (cued by emailed session summaries) for MI after Session 1 comprises review of their pros/cons balance sheet, and after Session 2, review of alcohol change plan or harm minimization strategies (if not ready to make a change). Brief post session SMSs remind the young person about the benefits of alcohol change they identified and any alcohol-related goals and plans. Four reminder SMSs with the same content are sent at 2, 4, 8 and 10 months post-baseline.

ii) Brief Personality-Targeted Intervention (PI): PI incorporates personality specific AF, MI and cognitive-behavioural coping skills training components. The intervention targets how individuals with specific personality risk factors cope with their vulnerability to alcohol misuse. In Session 1, the young person is given personalised AF, that includes psychoeducation about their dominant personality trait (anxiety proneness, depression proneness, impulsivity, or sensation seeking), associated problematic, personality-specific coping behaviors (e.g. avoidance, aggression, risky behaviors), and how this may affect their alcohol and other substance use. Participants are given information on alcohol harm minimization strategies and are encouraged to think about how they could have used some of these strategies to prevent the recent alcohol-related injury or illness which resulted in their ED admission. In contrast to standard MI, PI does not restrict discussion of potential change strategies to participants who elect to change their drinking. Instead, it encourages them to develop implementation intentions, which are specific hypothetical or actual plans for change, which take the form “if situation Y is encountered, I could use Z coping behaviour, in order to achieve my alcohol use goal”. Young people are guided to develop an implementation intention for future alcohol use situations. They are asked to identify an alcohol use situation in which they could test this alcohol plan in the next week and are asked to rate their level of confidence (1-10) in implementing the plan. They are emailed a session summary and a brief SMS message as a reminder.
In Session 2, the young person’s success in implementing their alcohol use plan is reviewed and if necessary, the plan is revised. Young people then receive personality-specific training in two cognitive behavioural coping skills. Those predominantly with anxiety proneness are given training in mindful breathing and thought awareness and acceptance training for anxious thoughts. Young people high in depression proneness receive behavioural activation and thought awareness and acceptance training for depressive thoughts. Sensation seekers receive training in savouring techniques to increase their awareness and ability to focus on and experience positive feelings from everyday activity (e.g. mindful eating) and are encouraged to identify and schedule natural highs from functional activities (e.g. exercise, skateboarding, rock climbing) and daily experiences (food, sex, music). Young people with high levels of impulsivity receive mindfulness training to increase awareness of their thoughts and are encouraged to apply the Stop-Think-Do rubric to help them slow down their decision-making processes sufficiently to consider likely outcomes of behavioural alternatives. Session 2 concludes with the young person developing an implementation intention for future alcohol-related situations, which incorporates their personality-specific coping skills. A session summary and a SMS reminder of their alcohol use plan is subsequently sent. As in MI, SMSs are sent at 2, 4, 8 and 10 months post-baseline to remind the participant of their alcohol use plan.
Intervention code [1] 286404 0
Treatment: Other
Intervention code [2] 286417 0
Behaviour
Comparator / control treatment
iii) Assessment Feedback and Information (AF): AF participants receive personalised assessment feedback on their alcohol use and information on the physical, psychological and social effects of alcohol use (via a brochure). The young person is emailed a copy of the information brochure after the session and an SMS containing generic information on effects of alcohol use.
Control group
Active

Outcomes
Primary outcome [1] 288727 0
Alcohol use (quantity/frequency of days alcohol use/days abstinent assessed on the Timeline Followback (TLFB) and related problems (eg., social, medical, legal, family, vocational assessed on the Rutgers Alcohol Problem Index (RAPI).
Timepoint [1] 288727 0
3, 6 and 12 months post baseline
Secondary outcome [1] 300851 0
Psychological distress (Kessler 10, K10)
Timepoint [1] 300851 0
1, 3, 6 and 12 months follow up
Secondary outcome [2] 300873 0
Functioning (Global Assessment of Functioning, GAF; Social and Occupational Functioning Scale, SOFAS)
Timepoint [2] 300873 0
1, 3, 6 and 12 months
Secondary outcome [3] 300874 0
Severity of problematic alcohol use (Alcohol Use Disorders Inventory, AUDIT)
Timepoint [3] 300874 0
1, 3, 6 and 12 months
Secondary outcome [4] 300875 0
Alcohol-related injuries (Extended Adolescent Injury Checklist; E-AIC)
Timepoint [4] 300875 0
1, 3, 6 and 12 months
Secondary outcome [5] 300876 0
Coping self-efficacy to resist using alcohol (Controlled Drinking Self-Efficacy Scale, CDSE)
Timepoint [5] 300876 0
1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Inclusion criteria are: aged 16-25 years, and either consumed more than 6 standard drinks on one occasion in the previous 2 weeks or scored equal to or greater than 8 on the 10-item Alcohol Use Disorders Identification Test (AUDIT). Users of illicit drugs including cannabis are eligible, as long as alcohol is the most frequently used drug (other than tobacco).
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: (i) ED presentation for a suicide attempt or serious medical problem or traumatic injury; (ii) not fluent in spoken or written English; (iii) unmodified hearing impairment; (iv) estimated IQ < 70 measured by the National Adult Reading Test; (v) current or past history of psychosis; (vi) history of traumatic brain injury, organic brain disease or significant cognitive impairment; (vii) currently in acute alcohol or drug withdrawal, and (viii) received psychological treatment for a drug or alcohol problem in the previous month.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization sequence will be concealed within a secure, online website. The trial manager will log on to this website when a new patient provides informed consent, enter the patient’s details, and the allocation group will be revealed. The CIs, follow-up assessors and trial statistician will be blind to treatment group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will generate a computerised random number sequence incorporating permuted blocks that will be used to allocate participants to one of three treatment groups (i) AF; (ii) Quik Fix MI or (iii) PI. Stratification by gender and age (16-20 years, 21-25 years) is applied.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Preliminary statistical analyses will be undertaken to check for baseline group differences on demographic, primary and secondary outcome variables using one-way analysis of variance and chi-square analyses. Intent-to-treat strategies will be used for the main analyses. To determine whether there are group differences on the primary and secondary outcome measures at 1, 3, 6 and 12 months a series of mixed effects model repeated measures analyses of variance (MMRM) will be employed. The within groups factor will be time (baseline, 1, 3, 6 and 12 months) and group will serve as the between subjects factor. This technique will control for potential confounding variables such as gender, age, injury severity and other drug use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2013
Actual
23/09/2013
Date of last participant enrolment
Anticipated
29/02/2016
Actual
30/11/2015
Date of last data collection
Anticipated
27/12/2016
Actual
27/12/2016
Sample size
Target
390
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 503 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 6244 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286628 0
Government body
Name [1] 286628 0
National Health & Medical Research Council (NHMRC)
Country [1] 286628 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology (QUT)
Address
60 Musk Avenue
Kelvin Grove
Brisbane QLD 4059
Country
Australia
Secondary sponsor category [1] 285413 0
None
Name [1] 285413 0
Address [1] 285413 0
Country [1] 285413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288706 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 288706 0
Human Research Ethics Committee
Post Office Herston
Herston Brisbane QLD 4029
Ethics committee country [1] 288706 0
Australia
Date submitted for ethics approval [1] 288706 0
29/01/2013
Approval date [1] 288706 0
09/04/2013
Ethics approval number [1] 288706 0

Summary
Brief summary
Nationally, 10,000 young Australians present to emergency departments with alcohol-related injuries and illnesses each month. Much of this adversity could be prevented if more young people had access to effective brief interventions (BIs) for alcohol use. Telephone-delivered BIs provide an innovative, youth friendly and accessible way of delivering treatment. This is the first randomized controlled trial (RCT) to compare the efficacy and cost-effectiveness of telephone-delivered BIs for reducing alcohol use and related harm in young people. 390 young people who present to an emergency department with an alcohol-related injury/illness will be randomized to receive: (i) 1 session of assessment feedback and information (AF); (ii) 2 sessions of AF plus motivational interviewing intervention (MI), or (iii) 2 sessions of a new personality-targeted intervention (PI) incorporating AF and MI.
Hypotheses
Efficacy will be greatest for PI, followed by MI, and then AF at 1, 3, 6 and 12 months in terms of the:
(i) the primary outcome variables of alcohol use and related problems, and
(ii) secondary outcome variables of psychological distress, functioning, severity of alcohol dependence, alcohol injuries, coping self-efficacy to resist using alcohol, and cost effectiveness
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37362 0
Prof Leanne Hides
Address 37362 0
School of Psychology, The University of Queensland
Lvl 2, Room 231, McElwain Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 37362 0
Australia
Phone 37362 0
+61733656000
Fax 37362 0
Email 37362 0
[email protected]
Contact person for public queries
Name 37363 0
Leanne Hides
Address 37363 0
School of Psychology, The University of Queensland
Lvl 2, Room 231, McElwain Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 37363 0
Australia
Phone 37363 0
+61733656000
Fax 37363 0
Email 37363 0
[email protected]
Contact person for scientific queries
Name 37364 0
Leanne Hides
Address 37364 0
School of Psychology, The University of Queensland
Lvl 2, Room 231, McElwain Building, 24A, St Lucia Campus, Brisbane, QLD 4072
Country 37364 0
Australia
Phone 37364 0
+61733656000
Fax 37364 0
Email 37364 0
[email protected]

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