Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19133888

Publication citations

  1. 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.

Additional files

Editorial Notes