ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

alcohol use in young people

Condition category

Condition code

Mental Health

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]

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]

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]

baseline, 3, 6 and 12 months

Primary outcome [2]

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]

baseline, 3, 6 and 12 months

Secondary outcome [1]

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]

baseline, 3, 6 and 12 months

Secondary outcome [2]

Point prevalence of substance use related adverse psychosocial outcomes as measured by a telephone administered standardised questionnaire (in French)

Timepoint [2]

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?

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]

Switzerland

State/province [1]

Romandie

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Swiss Academy of Medical Science (Kathe-Zingg-Schwichtenberg-Fonds)

Address [1]

Petersplatz 13
4051 Basel

Country [1]

Switzerland

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Safra Foundation, Geneva University Hospitals, Switzerland

Address [2]

4 rue Gabrielle-Perret-Gentil, 1211 Geneve 14

Country [2]

Switzerland

Funding source category [3]

Government body

Name [3]

Federal Office of Public Health, Switzerland

Address [3]

Schwarztorstrasse 96, CH-3007 Bern

Country [3]

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]

Hospital

Name [1]

Department of Community Medicine and Primary Care

Address [1]

4 rue Gabrielle-Perret-Gentil, 1211 Geneve 14

Country [1]

Switzerland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Commission d'ethique pour la recherche clinique en ambulatoire

Ethics committee address [1]

12 rue Micheli-du-Crest, 1205 Geneve 4

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

01/09/2008

Approval date [1]

24/09/2008

Ethics approval number [1]

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

Dr Dagmar HALLER

Address

Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4

Country

Switzerland

Phone

+4122379 50 61

Fax

dagmar.haller-hester@hcuge.ch

Contact person for public queries

Name

Dagmar HALLER

Address

Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4

Country

Switzerland

Phone

+41 22 379 50 61

Fax

+41 22 372 33 88

dagmar.haller-hester@hcuge.ch

Contact person for scientific queries

Name

Dagmar HALLER

Address

Primary Care Unit (UIGP), Faculty of Medicine, CMU
1 rue Michel Servet
1211 GENEVE 4

Country

Switzerland

Phone

+41 22 379 50 61

Fax

+41 22 372 33 88

dagmar.haller-hester@hcuge.ch

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

Source	Title	Year of Publication	DOI
Embase	Reasons for encounter in young people consulting a family doctor in the French speaking part of Switzerland: a cross sectional study.	2015	https://dx.doi.org/10.1186/s12875-015-0375-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically