Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000432314
Ethics application status
Approved
Date submitted
8/08/2008
Date registered
29/08/2008
Date last updated
12/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
BRIEF INTERVENTION ADDRESSING SUBSTANCE USE IN YOUNG PEOPLE CONSULTING FAMILY DOCTORS: A CLUSTER RANDOMISED TRIAL
Scientific title
Brief primary care intervention to reduce excessive substance use in young people
Secondary ID [1] 696 0
nil
Universal Trial Number (UTN)
Trial acronym
PRISM-Ado
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cannabis use in young people 3521 0
alcohol use in young people 3522 0
Condition category
Condition code
Mental Health 3675 3675 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief (5-10 minutes) one-off preventive intervention in primary care, discussing cannabis and/or alcohol use with young people in the general practice consultation
Intervention code [1] 3239 0
Early detection / Screening
Comparator / control treatment
usual care, i.e. care for the problem for which the young person is consulting the doctor, plus preventative care usually offered by this doctor to his/her patients
Control group
Active

Outcomes
Primary outcome [1] 4581 0
point prevalence of self-reported hazardous cannabis consumption in the past 30 days as measured by a telephone administered standardised questionnaire (in French)
Timepoint [1] 4581 0
baseline, 3, 6 and 12 months
Primary outcome [2] 4582 0
Point prevalence of self-reported hazardous alcohol consumption in the past 30 days as measured by a telephone administered standardised questionnaire (in French)
Timepoint [2] 4582 0
baseline, 3, 6 and 12 months
Secondary outcome [1] 7742 0
Point prevalence of self-reported abstinence from cannabis and / or alcohol in the past 30 days as measured by a telephone administered standardised questionnaire (in French)
Timepoint [1] 7742 0
baseline, 3, 6 and 12 months
Secondary outcome [2] 7743 0
Point prevalence of substance use related adverse psychosocial outcomes as measured by a telephone administered standardised questionnaire (in French)
Timepoint [2] 7743 0
baseline, 3, 6 and 12 months

Eligibility
Key inclusion criteria
young people consulting family doctors for any health problem
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acute illness requiring immediate attention of the physician, severe mental disorder such as psychosis or suicidal thoughts requiring treatment in a specialised setting, drug or alcohol abuse requiring more immediate attention (such as for example alcohol abuse and recent court ruling regarding drunk driving), previous treatment for cannabis or alcohol dependence

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The unit of randomisation will be the family doctors. The randomisation list will be computer generated by a researcher unlinked to the trial, who will not know the participating doctors. The doctors will know to which group they are allocated by contacting the holder of the allocation schedule.
Young participants will be recruited as they attend the practice for a consultation.
Allocation of their doctor will be concealed from the patients, but doctors themselves will not of course be blind to their allocation group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated sequence required from a statistician not involved in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cluster randomisation with the doctor as the unit of randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
30/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
594
Recruitment outside Australia
Country [1] 1103 0
Switzerland
State/province [1] 1103 0
Romandie

Funding & Sponsors
Funding source category [1] 3706 0
Charities/Societies/Foundations
Name [1] 3706 0
Swiss Academy of Medical Science (Kathe-Zingg-Schwichtenberg-Fonds)
Country [1] 3706 0
Switzerland
Funding source category [2] 3789 0
Charities/Societies/Foundations
Name [2] 3789 0
Safra Foundation, Geneva University Hospitals, Switzerland
Country [2] 3789 0
Switzerland
Funding source category [3] 243997 0
Government body
Name [3] 243997 0
Federal Office of Public Health, Switzerland
Country [3] 243997 0
Switzerland
Primary sponsor type
University
Name
Department of Community Health and Medicine, University of Geneva
Address
1 rue Michel-Servet
1211 Geneve
Country
Switzerland
Secondary sponsor category [1] 3323 0
Hospital
Name [1] 3323 0
Department of Community Medicine and Primary Care
Address [1] 3323 0
4 rue Gabrielle-Perret-Gentil, 1211 Geneve 14
Country [1] 3323 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5758 0
Commission d'ethique pour la recherche clinique en ambulatoire
Ethics committee address [1] 5758 0
12 rue Micheli-du-Crest, 1205 Geneve 4
Ethics committee country [1] 5758 0
Switzerland
Date submitted for ethics approval [1] 5758 0
01/09/2008
Approval date [1] 5758 0
24/09/2008
Ethics approval number [1] 5758 0
protocole 08-28

Summary
Brief summary
When excessive alcohol or cannabis use occurs at a vulnerable age such as adolescence, the physical, psychological and developmental consequences extend into adulthood. Good level evidence favours brief interventions to prevent harm associated with substance use in a variety of settings.
The purpose of this study is to assess the effectiveness of a brief intervention addressing excessive substance use in reducing the prevalence of excessive substance use in young people consulting family doctors (paediatricians, general practitioners and general internists).
Building on the experience of a pilot study in which we developed and successfully tested such a brief intervention in seven family practices in and around Geneva, we have designed a cluster randomised trial in primary care which aims to provide evidence of the effectiveness of this intervention. We hypothesise that the intervention can lead to a 15% reduction in the prevalence of at-risk alcohol and/or cannabis use in this population.
Trial website
http://sante-jeunes.hug-ge.ch/EtudePrism-Ado.html
Trial related presentations / publications
Haller DM, Meynard A, Ukoumunne O, Narring F, Broers B.
Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized trial.
Canadian Medical Association Journal 2014 May 13,186(8):E263-72.

Meynard A, Broers B, Lefebvre D, Narring F, Haller DM. Why do young people go to their family doctor in Switzerland? ICPC-2 coded reasons for encounter in young people consulting a primary care physician in the French speaking part of Switzerland. BMC family practice 2015

Haller DM, Meynard A, Lefebvre D, Hasselgard-Rowe J, Broers B, Narring F.
Excessive substance use among young people consulting family doctors: a cross-sectional study. Family Practice 2015, Oct;32(5):500-4

34. Haller DM, Meynard A, Lefebvre D, Tylee A, Narring F, Broers B. Brief intervention addressing excessive cannabis use in young people consulting family practitioners: a pilot study. British Journal of General Practice 2009; 59 (560): 166-172
Public notes

Contacts
Principal investigator
Name 28819 0
Dr Dagmar HALLER
Address 28819 0
Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4
Country 28819 0
Switzerland
Phone 28819 0
+4122379 50 61
Fax 28819 0
Email 28819 0
[email protected]
Contact person for public queries
Name 11976 0
Dr Dagmar HALLER
Address 11976 0
Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4
Country 11976 0
Switzerland
Phone 11976 0
+41 22 379 50 61
Fax 11976 0
+41 22 372 33 88
Email 11976 0
[email protected]
Contact person for scientific queries
Name 2904 0
Dr Dagmar HALLER
Address 2904 0
Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4
Country 2904 0
Switzerland
Phone 2904 0
+41 22 379 50 61
Fax 2904 0
+41 22 372 33 88
Email 2904 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReasons for encounter in young people consulting a family doctor in the French speaking part of Switzerland: a cross sectional study.2015https://dx.doi.org/10.1186/s12875-015-0375-x
N.B. These documents automatically identified may not have been verified by the study sponsor.