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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: 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) CONDITION: Alcohol use and related problems/injuries psychological distress PRIMARY OUTCOME: 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. 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. 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). SECONDARY OUTCOME: 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. 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. 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. 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. 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. 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. 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.
Epistemonikos ID: b7ba43ba9fadd665313e86636c0e70487865dcff
First added on: Aug 25, 2024