Condition category
Mental and Behavioural Disorders
Date applied
17/12/2013
Date assigned
17/12/2013
Last edited
28/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Problems associated with alcohol misuse are becoming increasingly common in people with learning disabilities due to much more ready access to alcohol associated with living in the community. There are no specific treatments for people with mild to moderate learning disabilities that can help with harmful use of alcohol. In this study we want to examine if a psychological intervention that is available to adults with Alcohol Use Disorders (AUD), called Extended Brief Intervention (EBI), can be delivered to people with mild to moderate learning disabilities. The National Institute of Health and Clinical Excellence recommends EBI for people with AUD before they receive any more specialist treatment. It includes three to five sessions with a trained professional and follow up in addition to usual care (medical, nursing and social input). There is one study of EBI in people with learning disabilities. These people were patients in a psychiatric hospital and was not compared with usual care. Therefore, we need to carry out a study to explore if and how EBI could be offered in the community.

Who can participate?
We will recruit 50 people from all the community learning disabilities services in Hertfordshire and North Essex. We will recruit men and women who are older than 18 years, have mild or moderate learning disability and who use alcohol in a harmful way.

What does the study involve?
Participants will be randomly allocated to one of two groups. Group 1 will receive their usual care with an additional half-hour EBI session every week and a final one-hour EBI session at eight weeks. Group 2 will receive their usual care. We will investigate if the study is acceptable, if service users would like to take part, if we can engage clinicians, and if the research questionnaires we have chosen perform well. We will assess participants and their carers at the start of treatment, the end of treatment and at 3 months. At around week 12 we will interview service users, carers and clinicians to find out what they thought of EBI.

What are the possible benefits and risks of participating?
Participants will have the chance to receive a treatment for their alcohol problem. This treatment will be modified to meet the needs of people with mild to moderate learning disabilities. We are not expecting any side effects from this treatment. If our study shows that it is feasible to offer EBI to people with mild to moderate learning disabilities, then we will do a bigger study to investigate if the addition of EBI to usual care is a better treatment than usual care alone.

Where is the study run from?
The study is organised by the Hertfordshire Partnership NHS Foundation Trust in collaboration with University College London. It will take place in Hertfordshire and North Essex and will recruit from all 10 community learning disabilities teams.

When is the study starting and how long is it expected to run for?
January 2014 to February 2015

Who is funding the study?
National Institute of Health Research (UK)

Who is the main contact?
Dr Christos Kouimtsidis
drckouimtsidis@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sophie Nicholls

ORCID ID

Contact details

Warren Court
Eric Shepherd Forensic Services
Woodside Road
Abbots Langley
WD5 0HT
United Kingdom
-
sophie.nicholls@hpft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15271

Study information

Scientific title

A feasibility study of a psychological intervention to address alcohol misuse for people with mild to moderate learning disabilities living in the community

Acronym

Study hypothesis

Can we design a feasible large scale randomised controlled trial that will address whether Extended Brief Intervention is more effective than usual care in helping persons with mild to moderate learning disabilities to manage hazardous or harmful drinking?

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15271

Ethics approval

NRES Committee South Central - Berkshire, 03/05/2013, ref: 13/SC/0143

Study design

Randomised interventional treatment trial

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 Research Network; Subtopic: Addictions, Learning difficulties development disorders; Disease: Addictive Substances– alcohol, Learning difficulties

Intervention

Based on the guidelines by the MRC, our feasibility study is in three stages:
1. Adaptation of the intervention from existing literature, feedback from professionals and service users with learning disabilities and the therapist (4 months)
2. Completion of a single-blind randomised controlled trial of EBI and usual care versus usual care to investigate whether the study is acceptable and service users can be recruited, whether we can engage clinicians, and whether the instruments we have chosen perform well (24 months)
3. A qualitative study to examine what service users, carers and service providers thought of EBI (overlaps with phase 2)
The duration is 30 months in total. We will use the data from the study to apply for a large trial.

As this is a feasibility study we have not performed a sample size calculation. However, we aim to recruit up to 50 (minimum 40) participants, which will allow us to analyse the data in terms of descriptive statistics and point and interval estimations.

EBI and usual care versus usual care

Extended Brief Intervention, Extended Brief Intervention (EBI) modified as described in stage 1. It will be provided over five half hour weekly sessions and there will be a final one hour session after eight weeks.; Follow Up Length: 3 month(s); Study Entry : Single Randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

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

Primary outcome measures

Reduction in primary outcome scores: the percentage of days of abstinence (PDAS) and percentage of days of heavy drinking

Secondary outcome measures

Secondary outcomes will be willingness to change, health status, service use and mental status. Feasibility outcomes: we will record weekly recruitment rates, loss to follow up, compliance rates (number of sessions attended) and basic costs. We will also measure completion rates to assess acceptability.

Overall trial start date

06/01/2014

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with mild to moderate learning disabilities aged 18 years who are known to professionals within the learning disabilities services as possibly having an alcohol problem will be eligible to be referred to the study. Once found to be eligible to take part, they will be further assessed with the WASI to assess their level of cognitive functioning (unless results from a previous cognitive assessment are available). Once consented to participate, they will be screened using the Alcohol Use Disorder Identification Test (AUDIT).

Inclusion criteria:
1. AUDIT score >8 and up to 19. We appreciate that the NICE (18) advice is to reduce scores in particular populations in which prevalence of AUD is lower than the general population such as older people, females and younger people. Local data, however, suggests that the prevalence of AUD in the local population with mild to moderate learning disability in contact with treatment services using AUDIT 8 as the cut-off point is 22.5%, which is similar to the prevalence in the general population. Therefore, we have decided to adopt the same cut-off AUDIT score as in the general population and to consider any changes, e.g. lowering the cut-off, following the findings from the study.
2. Residents in the area within the last 12 months.
3. Full Scale IQ<70 (+/5% CI).
4. Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. Severe to profound learning disabilities
2. Non-English speaking
3. Receipt of treatment for alcohol-related problems in the last 12 months
4. Severe and enduring mental illness
5. Polysubstance misuse including alcohol where the illicit substance, e.g. cocaine/heroin/cannabis is the main problem.

Recruitment start date

06/01/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warren Court, Eric Shepherd Forensic Services
Abbots Langley
WD5 0HT
United Kingdom

Sponsor information

Organisation

Hertfordshire Partnership Foundation NHS Trust (UK)

Sponsor details

Hertfordshire Partnership Foundation NHS Trust
99 Waverley Road
St. Albans
AL3 5TL
United Kingdom
-
t.gale@herts.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG1111-26022

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873255

Publication citations

Additional files

Editorial Notes

28/01/2016: Publication reference added.