Condition category
Mental and Behavioural Disorders
Date applied
05/06/2014
Date assigned
05/06/2014
Last edited
13/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

King's College London

Sponsor details

National Nursing Research Unit
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

12/10/2016: The following changes have been made to the record: 1. The primary and secondary outcome measures have been updated 2. The recruitment dates have been updated from 01/07/2014 - 30/06/2015 to 08/10/2014 - 31/08/2016 3. The overall trial dates have been update from 01/07/2014 - 30/06/2015 to 01/03/2014 - 28/02/2017 4. The ethics approval information, trial participating centres, plain English summary, publication and dissemination plan, and availability of the participant level data has been added