Training family members and carers of opiate users in overdose management and naloxone administration

ISRCTN	ISRCTN76786302
DOI	https://doi.org/10.1186/ISRCTN76786302
Protocol serial number	N/A
Sponsor	Institute of Psychiatry, Kings College London (UK)
Funders	Institute of Psychiatry, Kings College London (UK), Institute of Social Psychiatry (UK), University of London (UK) - Central Research Funds, Alban Programme (UK)

Submission date: 22/04/2010
Registration date: 05/05/2010
Last edited: 07/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Anna Williams
Scientific

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

Phone	+44 (0)20 7848 0027
Email	anna.v.williams@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional multicentre non-blinded controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Training family members and carers of opiate users in overdose management naloxone administration: a randomised trial
Study objectives	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(s)	The Joint South London and Maudsley and Institute of Psychiatry NHS Research Ethics Committee, 27/02/2009, ref: 08/H0807/90
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	09/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Total final enrolment	187
Key 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
Key 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
Date of first enrolment	09/10/2009
Date of final enrolment	09/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychiatry, King's College London

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2014	07/08/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.