Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000524998
Ethics application status
Not yet submitted
Date submitted
18/05/2011
Date registered
23/05/2011
Date last updated
23/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of the efficacy and cost-effectiveness of three telephone-delivered interventions for young people presenting to an emergency department (ED) with alcohol related injuries or illnesses. A pilot study.
Scientific title
In young people presenting to ED with alcohol related injuries or illnesses, what is the effect of three different telephone interventions on subsequent alcohol use and related problems? A pilot-study to determine cost-effectiveness and efficacy.
Secondary ID [1] 262198 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use and related problems/injuries 265880 0
psychological distress 265881 0
Condition category
Condition code
Mental Health 266040 266040 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants receive standard care in the ED. This comprises a 5-10 minute session of screening (daily alcohol, frequency of > 6 drinks/occasion, use of illicit drugs/injected drugs), information and referral (e.g. detoxification) where appropriate. The nature of this session is recorded, to check comparability across conditions.
Eligible and consenting participants are randomized to receive a 1x30 min telephone session of AF/I, 2x30 min sessions of Quik-Fix Brief Motivational Intervention (BMI) or 2x30 min sessions of Functional Decision Making (FDM). First contact to confirm eligibility is within 2 working days after ED presentation to maximize engagement. BMI and FDM are delivered over a maximum of 3 weeks to allow for missed appointments. Three reminder SMSs are sent to participants at 2, 3 and 5 months post baseline. Follow up assessments on all treatment outcome variables are at 3 and 6 months.
Assessment Feedback and Information (AF/I)
AF/I participants receive personalised normative Assessment Feedback and Information on physical, psychological and social effects of alcohol use. AF/I is delivered sensitively, but MI principles are not used. The 3 subsequent SMSs contain generic information on the effects of alcohol use.
Quik-Fix BMI
This comprises AF/I delivered in an motivational interviewing (MI) style (i.e. empathically, amplifying the person’s own concerns), plus MI about alcohol to: (a) build readiness and commitment to make a change (including pros and cons of current use and change), (b) negotiate change goals, and (3) develop a general 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). BMI is enhanced by incorporation of brief skills training for harm minimization and alcohol control (maximum of 2 skills: looking after yourself, positive event scheduling, stress reduction, thought management). Later SMSs ask the person to recall their expected benefits of alcohol control and (if they progressed beyond the first MI step) their alcohol-related goals and plans.
Functional Decision Making (FDM)
FDM embodies the spirit and components of Quik-Fix, but uses Ellaborated Intrusions (EI) Theory to carry rational decision making to the natural environment. Imagery of gains from alcohol control are rehearsed, and imagery-based cognitive therapy blunts appetitive thoughts. Meditation mindfulness audios assist in moving on from alcohol-related thoughts. Participants are encouraged to cue practice of strategies in the natural environment, and track actual positive changes. Regardless of their current motivation, they develop detailed implementation plans. (In participants wanting to change alcohol use, Quik-Fix skills training uses covert imagery-based rehearsal of these implementation plans). The 3 SMSs messages remind the person about their implementation intention and (in those wanting to change alcohol use) about the need to practice imagery and notice positive changes from alcohol control.
Intervention code [1] 264598 0
Other interventions
Intervention code [2] 264601 0
Treatment: Other
Intervention code [3] 264602 0
Behaviour
Comparator / control treatment
Assessment Feedback and Information (AF/I)
AF/I participants receive personalised normative Assessment Feedback and Information on physical, psychological and social effects of alcohol use. AF/I is delivered sensitively, but MI principles are not used. The 3 subsequent SMSs contain generic information on the effects of alcohol use.
Control group
Active

Outcomes
Primary outcome [1] 266782 0
Alcohol and other substance use and related problems/injuries. This will be assessed at 3 and 6 month follow-up using the following measures:
(i) Alcohol use: Time Line Follow Backs (TLFBs) over the previous 4 weeks assesses the frequency and quantity of alcohol and other substance use across the study. TLFB methods have high test-retest reliability (intraclass correlation coefficients (ICC)=.70-.94), convergent and discriminant validity with other substance use measures, collateral information and urine drug screens (UDS) for illicit drug use. A previous study by the CIA in young substance users found a high level of agreement between SUDS and self-reported drug use (83%). Whether additional drugs were used over the previous 6 months is also assessed, and at baseline, age of drinking onset is measured.
(ii) Alcohol-related problems and injuries. Alcohol-related problems (eg., social, financial, medical, legal, family, vocational) are assessed on the Rutgers Alcohol Problem Index (RAPI), a 23-item self-report measure commonly used in BI studies, and on CIBs 12-item DrugCheck Problem List (PL) Alcohol-related injuries are assessed on the Adolescent Injury Checklist (AIC). This 11-item measure records minor and major injuries, whether they required medical attention, and occurred in the context of alcohol or other drug use.
Timepoint [1] 266782 0
Baseline and 3 and 6 month follow-ups
Secondary outcome [1] 276378 0
psychological distress. The Kessler 10 (K10) is a 10-item self-report measure of psychological distress in the past month. A cut-off of 17 reliably detects the presence of depression and anxiety disorders in an Australian community sample.
Timepoint [1] 276378 0
Baseline and 3 and 6 month follow-ups.
Secondary outcome [2] 276379 0
functioning. This will be measured by clinician-rated tools. The Global Assessment of Functioning (GAF) as defined in DSM-IV, measures psychological, social and occupational functioning. The Social and Occupational Functioning Scale (SOFAS) assesses social and occupational functioning. The Modified Vocational Status Index (MVSI) provides an occupational status score and the Modified Location Code Index (MLCI) is a nine-point measure of residential status.
Timepoint [2] 276379 0
Baseline and 3 and 6 month follow ups
Secondary outcome [3] 276380 0
severity of alcohol dependence. The 16-item Severity of Alcohol Dependence Questionnaire (SADQ-C) measures the severity of alcohol dependence. This measure has demonstrated high levels of internal consistency and construct validity in Australian community samples.
Timepoint [3] 276380 0
Baseline and 3 and 6 month follow ups
Secondary outcome [4] 276381 0
Readiness to change alcohol use. A 12-item Readiness to Change Questionnaire (RTCQ) is measure young people's readiness to change their alcohol use. This measure has well established among alcohol users.
Timepoint [4] 276381 0
Baseline and 3 and 6 month follow ups
Secondary outcome [5] 276382 0
coping self-efficacy to resist using alcohol. CIBs 15-item Controlled Drinking Self-Efficacy Scale (CDSE)55 provides reliable and valid measure of self-efficacy to resist excessive drinking. Whether additional drugs were used over the previous 6 months is also assessed, and at baseline, age of drinking onset is measured.
Timepoint [5] 276382 0
Baseline and 3 and 6 month follow ups
Secondary outcome [6] 276383 0
Cost Effectiveness. A total health care and a personal cost perspective is taken. Costs of treatment provision, including staff costs, missed appointments, record keeping, training, materials, rent and overheads are included (Research costs are omitted). As participants may seek other treatment elsewhere, information on all other health care services will be collected using a Health Utilisation Service tool. Service prices are based on standard payment schedules (e.g. MBS). The Health Survey Short Form-12 (SF12) provides a measure of current physical, social and mental health and functioning. It has been used by the CIs to estimate the Quality-Adjusted Life Years (QALYs) in previous studies.
Timepoint [6] 276383 0
3 and 6 month follow ups
Secondary outcome [7] 276384 0
Treatment Fidelity. Treadment Fidelity is measured by subscales of the Yale Adherence and Competence Scale (YACS-II). Specifically the general subscales (assessment, general support, and goals for treatment) and motivational interviewing treatment subscale will be used to assess treatment fidelity. Additional items based on the essential features of FDM intervention will be added to the measure. For each item, an independent psychologist will rate adherence and implementation quality. Carroll et al. reported ICCs of 0.80-0.95 for adherence and 0.71-0.98 for competence on the YACS-II.
Timepoint [7] 276384 0
Completion of treatment

Eligibility
Key inclusion criteria
Inclusion criteria are: aged 16-25, and either consumed > 6 standard drinks on one occasion in the previous 2 weeks or scored > 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. Participants must have presented to an ED with alcohol related inujury or illness(es).
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 traumatic injury; (ii) not fluent in spoken or written English; (iii) unmodified hearing impairment; (iv) estimated IQ < 80; (iv) current or past history of psychosis; (v) history of traumatic brain injury, organic brain disease or significant cognitive impairment; (vi) currently in acute alcohol or drug withdrawal, and (vii) received psychological treatment for a drug or alcohol problem in the previous month. These criteria have been used in previous studies by the CIs.

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)
All participants receive standard care in the ED. After receiving a screening telephone call and baseline assessment, eligible and consenting participants are randomized to receive a 1x30 min telephone session of AF/I, 2x30 min sessions of Quik-Fix BMI or 2x30 min sessions of FDM.
Computerised random number generation incorporating permuted block randomization techniques are used to: (i) AF/I; (ii) Quik Fix BMI or (iii) FDM. Stratification will occur by age (16-21 years, 21-25 years). Randomization is by an independent statistician using a web-based random number generator (www.randomization.com). The trial manager is responsible for overseeing the assignment to treatment groups. The research officers and trial statistician will be blind to the randomization plan.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation incorporating permuted block randomization techniques are used to: (i) AF/I; (ii) Quik Fix BMI or (iii) FDM. Stratification will occur by age (16-21 years, 21-25 years). Randomization is by an independent statistician using a web-based random number generator (www.randomization.com). The trial manager is responsible for overseeing the assignment to treatment groups. The research officers and trial statistician will be blind to the randomization plan.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267101 0
University
Name [1] 267101 0
Institute of Health and Biomedical Innovation
Country [1] 267101 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute of Health and Biomedical Innovation
Address
60 Blamey St
Kelvin Grove
Brisbane QLD 4059
Country
Australia
Secondary sponsor category [1] 264185 0
None
Name [1] 264185 0
Address [1] 264185 0
Country [1] 264185 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 267080 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 267080 0
Level 2, U Block
Gardens Point Campus
Queensland University of Technology
Brisbane QLD 4001
Ethics committee country [1] 267080 0
Date submitted for ethics approval [1] 267080 0
23/05/2011
Approval date [1] 267080 0
Ethics approval number [1] 267080 0

Summary
Brief summary
This pilot study is the first randomized controlled trial (RCT) to compare the efficacy and cost-effectiveness of three telephone-delivered brief interventions for the rapidly increasing number of young people presenting to emergency departments (EDs) with alcohol-related injuries or illnesses. It randomizes patients to receive:
(i) 1 session of assessment feedback and information (AF/I),
(ii) 2 sessions of a brief motivational interviewing intervention (BMI), or
(iii) 2 sessions of a new motivational treatment based on recent theoretical and empirical advances by the CIs—Functional Decision Making (FDM).
Hypotheses
1. At 3 and 6 months, impacts on:
(a) the primary outcome variables of alcohol use and related problems/injuries, and
(b) secondary outcome variables of psychological distress, functioning, severity of alcohol dependence, readiness to change alcohol use and coping self-efficacy to resist using alcohol,
will be greatest for FDM, followed by BMI and then AF/I.
2. FDM will be the most cost-effective treatment, followed by BMI, and then AF/I.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32623 0
Address 32623 0
Country 32623 0
Phone 32623 0
Fax 32623 0
Email 32623 0
Contact person for public queries
Name 15870 0
Dr Leanne Hides
Address 15870 0
Institute of Health and Biomedical Innovation
GPO Box 2434
Brisbane QLD 4001
Country 15870 0
Australia
Phone 15870 0
+61 7 3138 6144
Fax 15870 0
Email 15870 0
[email protected]
Contact person for scientific queries
Name 6798 0
Dr Leanne Hides
Address 6798 0
GPO Box 2434
Brisbane QLD 4001
Country 6798 0
Australia
Phone 6798 0
+61 7 3138 6144
Fax 6798 0
Email 6798 0
[email protected]

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.