Condition category
Mental and Behavioural Disorders
Date applied
10/03/2008
Date assigned
25/04/2008
Last edited
25/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sips.sgul.ac.uk

Contact information

Type

Scientific

Primary contact

Prof Colin Drummond

ORCID ID

Contact details

Section of Alcohol Research
National Addiction Centre
PO48
Division of Psychological Medicine and Psychiatry
Institute of Psychiatry
King's College London
4 Windsor Walk
London
SE5 8BB
United Kingdom
colin.drummond@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SIPS-CJS

Study hypothesis

1. To conduct a pragmatic multicentre cluster randomised controlled trial of screening and brief interventions for hazardous and harmful drinkers in a probation setting in three English regions
2. To compare the effectiveness and cost effectiveness of a Client Information Leaflet (CIL) with simple structured advice conducted by offender managers (Tier 1) and referral to an alcohol health worker for brief lifestyle counselling (Tier 2) in clients with hazardous and harmful alcohol consumption identified by universal screening
3. To assess the relative impact of the three intervention strategies on alcohol screening and brief intervention activity in a probation setting
4. To identify the attitudinal, practical, skill, resource, and reinforcing factors that predict successful implementation of screening and brief intervention in probation
5. To identify the optimal method of alcohol screening in probation
6. To assess the relative impact of the three intervention strategies on uptake of alcohol services, including an alcohol helpline

Ethics approval

Northern & Yorkshire Research Ethics Committee (ref: 08/H0903/2 21/02/2008)

Study design

Cluster randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hazardous alcohol use

Intervention

1. Control condition: Offender managers will be trained to carry out screening and give all clients screened positive for hazardous or harmful alcohol use a Client Information Leaflet (CIL). Training will be carried out by experienced trainers for criminal justice staff in seminars and individual training as appropriate to the probation setting. Trainers will be specialist staff from local alcohol agencies or an alcohol health worker.

2. Simple structured advice condition: Offender managers allocated to this condition will be trained to carry out screening and deliver up to 5 min structured brief advice for hazardous and harmful drinkers presenting to their setting, using the Drink-Less brief intervention materials (level 1). Clients in this condition will also receive a CIL as above. Training will be carried out by experienced trainers for criminal justice staff in seminars and individual training as appropriate to the criminal justice setting. Trainers will be specialist staff from local alcohol agencies or an alcohol health worker. Each probation site will have an allocated coordinator who will champion screening and brief intervention and provide ongoing support and supervision for other staff.

3. Alcohol Health Worker (AHW) condition: All clients that screened positive by offender managers for hazardous/harmful drinking will be given a CIL and a 5 min structured brief advice as above, and referred to an AHW for a longer intervention. The AHW will be experienced in carrying out alcohol assessment and brief interventions. The AHW will carry out a brief lifestyle counselling intervention lasting for 15-20 minutes. The AHW will also be responsible for training and supporting probation staff in implementing screening and referral over the course of the project.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Alcohol Use Disorders Identification Test at 6 and 12 months

Secondary outcome measures

The following will be assessed at 6 and 12 months:
1. Health related quality of life, EuroQol (EQ-5D)
2. Alcohol problems questionnaire
3. Service utilisation
4. Staff attitudinal measures

Overall trial start date

01/04/2008

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Probation client scoring positive on either the Fast Alcohol Screen Test (FAST) or the Single Alcohol Screening Questionnaire (M-SASQ)
2. Alert and orientated
3. Aged 18 or over
4. Resident in England
5. Able to speak, read and write in English sufficiently well to complete study questionnaires
6. Not intoxicated
7. Not suffering with a serious mental health problem

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

435

Participant exclusion criteria

1. Already in contact with specialist alcohol services
2. Already included in the study or other alcohol research studies
3. Those requesting tertiary specialist help with alcohol problems

All excluded clients will be given information on where to obtain help for alcohol problems, and will receive a health information leaflet with the Drinkline number and website address.

Recruitment start date

01/04/2008

Recruitment end date

31/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Alcohol Research
London
SE5 8BB
United Kingdom

Sponsor information

Organisation

Kings College London, Institute of Psychiatry (UK)

Sponsor details

National Addiction Centre
PO48
Division of Psychological Medicine and Psychiatry
4 Windsor Walk
London
SE5 8BB
United Kingdom
paolo.deluca@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Government

Funder name

This trial is funded by the UK Department of Health as part of the government's Alcohol Harm Reduction Strategy for England (2004) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19922618

Publication citations

  1. Protocol

    Newbury-Birch D, Bland M, Cassidy P, Coulton S, Deluca P, Drummond C, Gilvarry E, Godfrey C, Heather N, Kaner E, Myles J, Oyefeso A, Parrott S, Perryman K, Phillips T, Shenker D, Shepherd J, Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol., BMC Public Health, 2009, 9, 418, doi: 10.1186/1471-2458-9-418.

Additional files

Editorial Notes