Condition category
Mental and Behavioural Disorders
Date applied
22/04/2010
Date assigned
05/05/2010
Last edited
11/08/2014
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.iop.kcl.ac.uk/departments/?locator=1111

Contact information

Type

Scientific

Primary contact

Ms Anna Williams

ORCID ID

Contact details

Institute of Psychiatry
King's College London
Addictions Department
Addiction Sciences Building
First Floor B12
4 Windsor Walk
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0027
anna.v.williams@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Training family members and carers of opiate users in overdose management naloxone administration: a randomised trial

Acronym

Study hypothesis

To evaluate the short-term effects of a group-based intervention to train family members and carers of opioid users in overdose management and naloxone administration and compare with control information-only intervention.

Alternative hypotheses under investigation:
1. The group-based training is effective in increasing family members' knowledge and positive attitudes towards managing an overdose when compared to the controlled intervention
2. The group-based training is effective in increasing family members' positive attitudes in overdose management overdose when compared to the controlled intervention
3. Changes promoted by the interventions are robust after 3 months

Secondary objectives:
1. To verify if family members succeed in having a naloxone supply prescribed to their opiate user relative after training
2. To verify if family members have witnessed and managed an overdose 3, 6 and 12 months after the interventions
3. To assess qualitative aspects of training through trainers' and trainees' feedback on the group-based intervention
4. To determine the acceptability of possible alternative routes and devices of naloxone administration among family members and carers

Ethics approval

The Joint South London and Maudsley and Institute of Psychiatry NHS Research Ethics Committee, 27/02/2009, ref: 08/H0807/90

Study design

Randomised interventional multicentre non-blinded controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Opioid overdose

Intervention

Intervention group:
The short-term objective of the training session is to produce an increase in knowledge, skills and positive attitudes towards managing an overdose. A group-based intervention previously used to train drug-using service users and clinicians in other studies conducted by the National Addiction Centre has been adapted for delivery among family members for the present study. The intervention should take approximately 2 hours. There will be two coordinators and 4 to 8 family members in each group. Sessions will be structured but informal to allow participants to interact.

The training session will be formed of two stages:
1. First there will be an oral presentation and all important aspects of managing an opiate overdose will be covered. The interactive session will include the following topics: how to recognise and manage an opioid overdose; an explanation of how naloxone reverses an opiate overdose; actions that should be taken and how naloxone should be administered. There will also opportunity for discussions and to clarify doubts and concerns on the topic.
2. The second stage will be a practice session. Trainers will demonstrate and participants will practice the skills which are going to be taught: how to manage an overdose and administer naloxone.

Each trained subject will receive copies of the presentation including guidelines on naloxone provision and links to useful websites. Information will be given on how to request a take-home emergency supply of naloxone through Addiction Services and GPs; this will be facilitated by the project.

Feedback form will be administered by the end of the session to assess quality and participants' satisfaction with training.

Control group:
At the moment in the Addiction Services across the UK family members are not offered training on overdose management. The current practice just includes the offer of information in the format of leaflets. For this reason the experimental intervention will be compared to the current practice of offering information only.

The control group will receive an information pack which will include:
1. Overdose booklet: produced by © Harm Reduction Works 'Overdose: everything you need to know'. The booklet contains comprehensive information about causes and signs of overdose, myths and actions to be taken.

Reading time for the information pack will be approximately 15 minutes. Participants from the control group will be given the pack and asked to immediately read it. This pack will also be distributed to the experimental group.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at 6 and 12 months:
1. Scores on the Overdose Knowledge Scale (OD-KS): risk, signs, action and naloxone domains and totals score
2. Scores on the Overdose Attitudes Scale (OD-AS): competence, concerns and readiness domains and total score

Secondary outcome measures

Measured at 6 and 12 months:
1. Characteristics of the sample
2. Number of family members who requested and successfully obtained a naloxone supply after interventions
3. Number of family members who witnessed, experienced and managed an overdose at 3, 6 and 12 months after the intervention
4. Preferable route and device of naloxone administration stated by family members
5. Trainers' and trainees' feedback on the group-based training
6. Scores in the Symptom Rating Test

Overall trial start date

09/10/2009

Overall trial end date

09/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older, either sex
2. To have at least one family member (e.g., parent, partner, sibling, carer) who uses opioids
3. Opioid being the main drug type taken by their relative
4. To have sufficient knowledge of English to understand the study protocol, intervention and the research instruments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total sample size of 128 participants

Participant exclusion criteria

1. Not having close contact with the opioid user (e.g., if they do not live in same house or frequently visiting)
2. Already trained in overdose management and naloxone administration in the past 3 years
3. Not interested in taking part in the study
4. Not willing to accept randomisation

Recruitment start date

09/10/2009

Recruitment end date

09/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry, King's College London
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, Kings College London (UK)

Sponsor details

c/o Jennifer Liebscher
SLaM/IoP R&D Office
Room W 1.08
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/departments/?locator=26

Funders

Funder type

University/education

Funder name

Institute of Psychiatry, Kings College London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Social Psychiatry (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of London (UK) - Central Research Funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alban Programme (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

Publication citations

Additional files

Editorial Notes