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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000524998
Acronym
Nil
Enrollment
60
Registered
2011-05-23
Start date
2011-06-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Intervent

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.

Sponsors

Institute of Health and Biomedical Innovation
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026