Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Alcohol and other drug misuse considerably increases risks of early death, poor health and criminal behaviour. We have previously found that over 80% of men who have just arrived in Welsh prisons to await trial are problem drinkers and half of these are alcohol-dependent. Many also use illicit drugs. Three-quarters of these men have been imprisoned before. They may get medication for symptom relief, but it is unusual for them to have access to any other help for their substance use. Community-based studies have shown that medication alone has no long-term benefits, while adding psychosocial treatments may. No-one has yet shown that psychosocial treatments will work for this particular group of men who are in the early stage of a short stay in prison and keep returning there. We will test the idea that groups which help motivate men to change and give them lots of practical information about how to do so will, if added to the standard prison regime, increase their sense of being able to control their substance use, and that going to the groups will help them more in this way than the prison regime alone. If so, this may also bring other benefits. In other studies, improved sense of control has been linked to long-term change in drinking or drug use and social behaviours.

Who can participate?
Men who have just arrived in one prison and who are likely to stay for at least one month and not more than six months can participate in the study.

What does the study involve?
Information leaflets will be distributed to prisoners as they arrive in the prison. Potentially eligible prisoners will be identified from the prison administration system. A research worker will then meet with each such prisoner to discuss the study and to seek consent for participation, until enough have been recruited for each group cycle (about 10 who will go into the groups and about 10 who will not, each time). If they agree to participate, the men will understand that they have to allow us to choose randomly for them whether they follow the ordinary prison regime alone (including periods of association with other men, visits, exercise, medication for symptoms) or to do this and also go to nine educational, motivational and skill-building groups over three weeks. We will assess the group attendees before and after the group, and the men who do not attend. We will also assess aspects of their mental state, such as anxiety and depression. Other observations will include their ability to make a personal plan to stop using or reduce their use of alcohol and/or drugs and whether they later make contact with any services they referred to in their plan. We plan one contact with the men about three months after they have left the prison, when we will ask whether they have attended the community service(s) as they said they would, whether they have resumed drinking or using drugs, and we will reassess their sense of control over their actions in this respect. We anticipate that it may be difficult to contact many of the men, despite agreements to do so. Our fall-back position is that, having obtained their permission to do so during the post-group assessment, we would contact the service(s) they named, to check whether they did make contact.

What are the possible benefits and risks of participating?
All participating men will be shown positive interest in their difficulty with alcohol or drug misuse. We expect the men attending the groups to have an added advantage of gaining knowledge and skills which will help them stop or reduce drinking or drug use. In our initial study, we found no evidence that any participant was put at risk in any way through participation. A few men refused to participate. Most who did participate, whether in the groups or not, appeared to like the experience.

Where is the study run from?
Abertawe Bro Morgannwg University (ABMU) Health Board (UK) and Cardiff University (UK).

When is the study starting and how long is it expected to run for?
The study started in April 2014. It will run for 2 years.

Who is funding the study?
The National Institute for Social Care and Health Research (NISCHR), UK.

Who is the main contact?
Professor Pamela Taylor

Trial website

Contact information



Primary contact

Prof Pamela Taylor


Contact details

Institute of Psychological Medicine and Clinical Neurosciences
School of Medicine
Cardiff University
and ABMU Health Board
Hadyn Ellis Building
Maindy Road
CF24 4HQ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of an early group intervention to engage alcohol and other substance misusing short-term prisoners in appropriate health service use



Study hypothesis

It is hypothesised that a short programme of educational and supportive groups for alcohol and/or illicit drug dependent men, supplementing usual treatment, will be associated with an improved sense of control over their behaviour compared with men receiving only treatment as usual (TAU). The null hypothesis is that there will be no difference between the treatment groups.

Ethics approval

NHS Health Research Authority NRES Committee East of England - Essex, initial approval 11/03/2014, amendment approval 23/12/2014, ref: 14/EE/0046

Study design

Two-year single-site randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

This will be available on the Offender Health Research Network-Cymru after receipt of ethical approval to proceed:


Problem drinking and/or problem use of illicit drugs


All of the men will have access to all standard facilities or interventions, as required or available, within the prison for the duration of their involvement in the study. These will include exercise, association with other men and visits, as possible, from legal advisors, family and friends. Those suffering withdrawal symptoms may receive some sedative medication for support. All social or practical activity and any treatments will be recorded throughout to allow checking for comparability of 'treatment as usual' between the trial groups.
Half of the men, selected randomly, will receive a programme of nine groups over three weeks: four groups in week 1, three groups in week 2, two groups in week 3.
The groups will be facilitated by an experienced clinical psychologist and a psychology assistant.
With the exception of one group in week 2, which will include representatives of community services and will last up to 2 hours, each group will last 50-60 minutes.
The model underpinning the work is motivational interviewing, with the underlying concepts:
1. Change is possible
2. Control can be achieved
3. Relapse can be prevented and/or
4. Control resumed
Simple skills will be taught and practised during the sessions, for example relaxation for coping with physical tension, and cognitive problem-solving techniques. The principle of carrying skills over from one environment to another will be introduced through the process of cell work between sessions.

Added 15/01/2015:
Men who complete will have the option of registering for accreditation for a unit (Alcohol awareness for the individual) of level 1 City and Guilds Employability and Personal Development. Both intervention and control men will receive information packs about community services.

Intervention type



Drug names

Primary outcome measure

Locus of control as measured by the Locus of Control of Behaviour scale (Craig, A. R., Franklin, J. A., & Andrews, G. [1984]. A scale to measure locus of control of behaviour. British Journal of Medical Psychology, 57, 173-180). This measure will first be taken not more than 7 days before attending the groups and secondly not more than 7 days after completing them (about 4 weeks apart); the comparison men not doing the groups will complete the measure at about the same times as the men in the groups.

Secondary outcome measures

1. Substance use in this imprisonment: number of occasions reported and/or detected/adjudicated
2. Completion of a personal plan for substance misuse management after leaving prison: yes/no
3. Qualitative analysis of the plan, to identify components and themes in developing the plan
4. General mental state as measured before and after the groups or at equivalent times for non-group men using the Comprehensive Psychopathological Rating Scale (CPRS)
4. Specification of attendance at a relevant community facility: yes/no; specification of facility/facilities: yes/no
5. Actual attendance at the specified facility/facilities within three months of leaving prison. This will be assessed through contact with participants, where possible, with verification and/or additional information from checking with that facility or any other specified. When contact is made, each man will also be asked to complete the locus of control scale again.
6. Number of returns to prison/new charges or convictions, if any, in the 12 months after release (this time period has been selected because official crime statistics show that two-thirds of men under short-term sentences will re-offend within a year)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Men 18 years old or older
2. New receptions into one prison who are likely to remain there for more than four weeks but less than six months, regardless of pre-trial or conviction status (in previous research we have devised a system for correctly predicting the lower figure with 64% accuracy)
3. Experiencing withdrawal symptoms from alcohol and/or illicit drugs on/soon after arrival
4. Scoring 16+ on the Alcohol Use Disorders Identification Test (AUDIT) (Saunders JB, Aasland OG, Babor TF and De la Fuente JR. [1993]. Development of the Alcohol Use Disorders Identification test [AUDIT]. WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption. Addiction 88 [6]: 791)
5. Scoring 15+ on the Drug Abuse Screening Test (DAST) (Skinner HA. [1982]. The Drug Abuse Screening Test. Addictive Behaviours 7[4]:363-71)

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Being under a sentence of more than 12 months in prison
2. Not meeting the criteria for problem drinking and/or drug use, as above
3. Not having sufficient English language fluency to participate in the groups (we do not have sufficient resources to be able to run the groups in languages other than English)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychological Medicine and Clinical Neurosciences
CF24 4HQ
United Kingdom

Sponsor information


Abertawe Bro Morgannwg University Health Board (UK)

Sponsor details

c/o Jemma Hughes
Abertawe Bro Morgannwg University Health Board
Clinical Research Unit
Morriston Hospital
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Social Care and Health Research (RfPBB-1028)

Alternative name(s)

Sefydliad Cenedlaethol ar Gyfer Ymchwil Gofal Cymdeithasol ac Lechyd, NISCHR

Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

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

Basic results (scientific)

Publication list

2020 results in (added 12/02/2020)

Publication citations

Additional files

Editorial Notes

12/02/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 02/03/2017: The overall trial end date was changed from 31/01/2016 to 31/03/2017.