A randomised comparison of two levels of an intervention to work with relatives of alcohol and drug users in primary care

ISRCTN	ISRCTN46411517
DOI	https://doi.org/10.1186/ISRCTN46411517
Protocol serial number	RGC00393
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive West Midlands (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 14/01/2009

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

Mr Alex Copello
Scientific

School of Psychology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 0121 414 7191
Email	A.G.Copello@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To establish the effectiveness of an intervention designed to be used with patients in the primary care setting who are affected by the alcohol or drug problem of a relative. Each approach will be developed from existing evidence and based on the stress-coping-health model. The research aims to establish the most cost effective service for this client group within the primary care setting and by comparing the two approaches establish the key components of the intervention that lead to a positive outcome.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Alcohol/drug addiction
Intervention	The approaches will differ in the extent of input provided by the primary care professional 1. Self-help manual with minimal input 2. Self-help manual with a five step structured package including discussion on stress, coping and social support
Intervention type	Other
Primary outcome measure(s)	The main outcome measures are: For the relatives: 1. Total score on the Symptom Rating Test 2. Total and subscale scores on the Coping Questionnaire (Subscales: Engaged, Tolerant and Withdrawal) 3. In addition, categorical data on the engagement in treatment of the person with the alcohol/drug problem during the period of the intervention including whether the person engages in treatment (i.e. new episode) or remains in treatment (in cases where the person is already in contact with a service) For the PHCPs: Total and subscale scores on the adapted version of the Alcohol and Alcohol Problems Perception Questionnaire
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2002

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	143
Key inclusion criteria	Relatives of people with alcohol/drug problems are included if: 1. The relative considered that the drinking or drug taking of another member of the family had been a major source of distress 2. The relative with the alcohol/drug problem had been drinking or consuming drugs at some time during the last six months 3. The alcohol/drug user and relative had been living under the same roof at some point during the last six months
Key exclusion criteria	Those relatives of alcohol/drug users experiencing alcohol and drug problems themselves will be excluded from the study as it would be difficult to clearly separate the problems caused by their own use of substances as opposed to that of their relatives.
Date of first enrolment	01/04/2000
Date of final enrolment	01/04/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Psychology

Birmingham
B15 2TT
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	01/01/2009		Yes	No