Contact information
Type
Scientific
Primary contact
Mr Alex Copello
ORCID ID
Contact details
School of Psychology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 0121 414 7191
A.G.Copello@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGC00393
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2000
Overall trial end date
01/04/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
143
Participant 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.
Recruitment start date
01/04/2000
Recruitment end date
01/04/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive West Midlands (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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19133888
Publication citations
-
Results
Copello A, Templeton L, Orford J, Velleman R, Patel A, Moore L, MacLeod J, Godfrey C, The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial., Addiction, 2009, 104, 1, 49-58, doi: 10.1111/j.1360-0443.2008.02417.x.