Plain English Summary
Background and study aims
Alcohol is a major global threat to public health. Although the main burden of long-term alcohol-related disease is in adults, its foundations often lie in adolescence. Alcohol consumption and related harm increase steeply from the age of 12 until 20 years. Several studies focusing upon young people have reported significant positive effects of brief interventions on alcohol consumption. A recent assessment of reviews also suggests that electronic brief interventions (eBIs) using internet and smartphone technologies may also markedly reduce alcohol consumption. Interventions that target non-drinking youth are known to delay the onset of drinking behaviours. Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among ‘high-risk’ drinkers; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions. This study is made up of two parts and aims to look at the effectiveness and cost-effectiveness. The first part focus on high-risk adolescent drinkers attending Emergency Departments (ED) and the other will focus on those identified as low-risk drinkers or those who don’t drink but attending the same ED.
Who can participate?
Adolescents aged 14-18 who are high-risk drinkers attending an ED and low-risk or non-drinkers attending an ED.
What does the study involve?
After agreeing to take part, participants are asked to fill out a questionnaire using an iPad. The questionnaire asks about their diet, the exercise they take, whether they smoke and whether they drink alcohol. The questionnaire also asks about their health in general and how often they use health and social services. The questionnaire takes less than 15 minutes to complete, but for most people it should take around 5 minutes. Participants can choose to skip past questions or decide not to complete the questionnaire once they have started. The questionnaire is confidential and their answers are not be passed on to their parents/carers or doctors. Participants can complete it on their own, or ask for support from a member of the research team if something is not clear to them. Participants receive a £5 gift voucher for their time after completing the questionnaire. After they complete the questionnaire, some people are also be given some information about alcohol. Sometimes a researcher gives them this information and other times they might also be given information on a smartphone app. The information is given on the same day whilst they are in the Emergency Department and it takes no more than 15 minutes. Participants are contacted again two weeks later to ask them how they found taking part in the project. A member of the research team also contacts them to ask similar questions in 6 and 12-month time. This is either by phone or in person, depending on their preference. They receive a £5 gift voucher for their time after completing each follow up.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
St Thomas’ Hospital and nine other NHS hospitals in England (UK)
When is the study starting and how long is it expected to run for?
March 2014 to February 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Paolo Deluca
paolo.deluca@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paolo Deluca
ORCID ID
Contact details
Institute of Psychiatry
Department of Psychology (PO77)
16 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7848 0838
paolo.deluca@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16780
Study information
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
Acronym
SIPS jr RCT
Study hypothesis
The aim of this study is to:
1. Investigate the effectiveness and cost-effectiveness of alternative interventions in reducing alcohol consumption for high-risk alcohol using adolescents
2. Investigate the effectiveness and cost-effectiveness of alternative interventions in reducing the transition from low to high-risk alcohol consumption in low risk alcohol using adolescents
Ethics approval
NRES Committee London - Fulham, 06/08/2014, 14/LO/0721
Amendment approved: 25/08/2015
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health, Injuries and emergencies; Subtopic: Addictions, Injuries and Emergencies (all Subtopics); Disease: Addictions, Addictive Substances alcohol, Injuries and Emergencies
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/03/2014
Overall trial end date
28/02/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 1500; UK Sample Size: 1500
Participant 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
Recruitment start date
08/10/2014
Recruitment end date
31/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Trial participating centre
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Croydon Hospital
530 London Road
Croydon
CR7 7YE
United Kingdom
Trial participating centre
Ealing Hospital
Uxbridge Road
Southall
UB1 3HW
United Kingdom
Trial participating centre
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Trial participating centre
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Queen Elizabeth Avenue
Gateshead
NE9 6SX
United Kingdom
Trial participating centre
North Tees Hospital
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Trial participating centre
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
Trial participating centre
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal by September 2017. Final report to NIHR to be submitted by March 2017 and to be published on the NIHR Journal Series.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25886178