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 |
| Secondary identifying numbers | RGC00393 |
- 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
Scientific
School of Psychology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 0121 414 7191 |
|---|---|
| A.G.Copello@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 | 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 study start date | 01/04/2000 |
| Completion date | 01/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School of Psychology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive West Midlands (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
