Developing and evaluating interventions for adolescents with alcohol use disorders who present through emergency departments: randomised feasibility study and exploratory randomised controlled trial

• Register: ISRCTN
• Last refreshed on: 1 July 2019
• Main ID: ISRCTN45300218
• Date of registration: 05/06/2014
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Developing and evaluating interventions for adolescents with alcohol use disorders who present through emergency departments: randomised feasibility study and exploratory randomised controlled trial
• Scientific title: Developing and evaluating interventions for adolescents with alcohol use disorders who present through emergency departments: randomised feasibility study and exploratory randomised controlled trial
• Date of first enrolment: 08/10/2014
• Target sample size: 1500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN45300218
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Paolo Deluca

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age 14 years or more and less than 18 years
2. Alert and orientated, able to speak English sufficiently well to complete the research assessment
3. Able and willing to provide informed consent to screening, intervention and follow-up
4. If under 16 Gillick competent or having a parent/guardian able and willing to provide informed consent
5. Owning a smartphone or alternatively having access to the internet at home

Exclusion criteria:
1. Severe injury
2. Suffering from serious mental health problem
3. Gross intoxication
4. Patient, parent or guardian unable or unwilling to provide informed consent (if under 16)
5. Specialist services involved because of social or psychological needs
6. Receiving, or having received in the past 6 months, treatment for an alcohol or substance use disorder
7. Current participation in other alcohol research


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Mental Health, Injuries and emergencies; Subtopic: Addictions, Injuries and Emergencies (all Subtopics); Disease: Addictions, Addictive Substances? alcohol, Injuries and Emergencies
Mental and Behavioural Disorders

Intervention(s)

Screening and eBI: Following a simple feedback procedure participants will receive the eBI smartphone intervention. This is an offline-capable mobile web app which will work on a variety of platforms but will be optimised for recent iPhone and Android phones. It has been developed around the concept of a high street where users will be able to navigate/explore, learn facts and figures about alcohol and receive ongoing personalised feedback and support. Games components within the web app will include supporting a ; Screening and PFBA, Trained research assistants will be responsible for the delivery of the face-to-face brief advice that is tailored to high-risk alcohol users. The researcher will explain that the PFBA is designed specifically for young people who misuse alcohol and attend ED. Initially the research assistant will identify the young person as either a High or Low-risk alcohol user and discuss the risks associated with this or increasing levels of alcohol consumption (as indicated). The intervention will take 5 m; Screening only group (+TAU), To minimise possible intervention effects we will blind participants allocated to this study arm to the main aims of the trial. They will be told that the trial focuses on general health behaviours, including alcohol use. After agreeing to be followed up at 6 and 12 months patients will be then returned to the care of ED staff for usual care with no further interaction until the follow up stages.; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Primary Outcome(s)

Primary outcome measure as of 12/10/2016:
Total alcohol consumed over the past 3 months, in standard units (1 unit = 8g ethanol), is assessed using the Alcohol Use Disorders Identification Test – Consumption version (AUDIT-C) at baseline 6 and 12 months.

Original primary outcome:
The Timeline Follow Back 28 days (TLFB28) interview at 12 months

Secondary Outcome(s)

Secondary outcome measures as of 12/10/2016:
1. Percent days abstinent, drinks per drinking day and heavy episodic alcohol use will be measured using the AUDIT-C at baseline and then 6 and 12 months
2. High risk alcohol use will be measured using the Extended AUDIT-C questionnaire at baseline and then 6 and 12 months
3. Past year and lifetime alcohol use will be measured using question 19 from the ESPAD study at baseline and 12 months
4. The consequences associated with alcohol consumption will be measured using questions 21-22 from the ESPAD study at baseline and 12 months
5. General health and functioning will be measured using the Strengths and Difficulties Questionnaire measured at baseline and 12 months.
6. Health status will be measured using the EQ-5D-5L at baseline, 6 and 12 months
7. Service use including health and social services, school attendance and involvement in criminal justice will be measured using a bespoke version of the Client Service Receipt Inventory (CSRI) at baseline and then at 6 and 12 months

Original secondary outcome:
1. Economic outcome measures; Timepoint(s): Stage 2 will involve collecting data on the costs of the interventions together with data on use of
2. Process outcome measures; Timepoint(s): Expectancy will be measured using the ESPAD Question 21 (96), this will be assessed at baseline, pri;
3. Participants will also be asked questions about past year and lifetime alcohol use and the consequen

Secondary ID(s)

16780

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee London - Fulham, 06/08/2014, 14/LO/0721 Amendment approved: 25/08/2015

Results

• Results available: Yes
• Date Completed: 28/02/2017