Condition category
Mental and Behavioural Disorders
Date applied
18/01/2011
Date assigned
10/03/2011
Last edited
10/03/2011
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

Prof Rainer Thomasius

ORCID ID

Contact details

DZSKJ
Martinistrasse 52
Hamburg
20246
Germany
thomasius@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IIA5-2507DSM209

Study information

Scientific title

CAN Stop - psychoeducation and relapse prevention for young persons with problematic cannabis use - development and evaluation of a preventive group-based training programme [Psychoedukation und Rückfallprävention für junge Menschen mit problematischem Cannabiskonsum – Entwicklung und Evaluation eines Gruppenbehandlungsprogramms]

Acronym

CAN Stop

Study hypothesis

We hypothesise that young cannabis users who participated at the preventive CAN Stop group training in addition to the treatment or service usually provided in the specific help provision context (e.g. drug addiction aid and youth welfare, in-patient medical context, out-patient medical context, juvenile prisons) show lower level of cannabis intake and higher levels of cannabis abstinence-related self-efficacy after the training as opposed to young cannabis users who received the usual treatment or service.

Ethics approval

1. Ethics Committee of the Chamber of Physicians Hamburg approved on 3rd March 2009 (ref: PV3086)
2. Ethics Committee of the Schleswig-Holstein Chamber of Physicians approved on 6th May 2009 (ref: AZ 41/09)
3. Ethics Committee of the Chamber of Physicians North Rhine approved on 29th January 2010 (ref: 2009366)
4. Ethics Committee of the Chamber of Physicians Hesse approved on 2nd August 2010 (ref: MC 168/2010)

Study design

Four-arm randomised wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Problematic cannabis use

Intervention

The CAN Stop group training consists of eight group sessions of 90 minutes. Groups consist of six to ten young cannabis users and one or two trainers. The training's rationale is based on behavioural therapeutic and motivational interviewing elements. It encompasses consumer or craving diaries, the work with social and emotional context variables and potential triggers as well as the elaboration of alternative behaviour strategies and the activation of participants resources.

Generally and for motivational reasons, it is left open to participants within the training whether they want to reduce or stop their cannabis use. However, certain settings at which the training is tested officially require absolute consume stops (e.g. prisons), yet this is a characteristic of the respective institution and not of the training itself. After completing the CAN Stop training, certificates are handed out to participants who, participated at least at five out of eight group training sessions, for further gratification. If within a group, only three or less participants remain after other participants dropped out of the group, the group is not further continued.

Control participants receive the respective “treatment as usual”, which the setting, the person is in usually provides. After the follow-up assessment, participants are invited to take part at a CAN Stop group training if they wish to attend.

Timepoints:
t0 (pre) = before the training/ treatment as usual
t1 (post) = after the training/ treatment as usual which is 3 months after t0
t2 (follow-up) = 6 months after t1

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Cannabis use in the past 30 days
2. In case of ongoing cannabis use: approximate weight of used cannabis on a day with mean cannabis use

Measured at t0, t1 and t2

Secondary outcome measures

1. Motivation to change existing cannabis use
2. Cannabis abstinence-related self-efficacy
3. Psychosocial adjustment
4. Behaviour in the face of peer pressure with regard to cannabis use

Measured at t0, t1 and t2

Overall trial start date

15/02/2011

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 14 and 21 years, either sex
2. Cannabis consumed is deemed problematic by the young cannabis user or significant persons in his or her context (e.g. parents, teachers)
3. Participant's willingness to at least think over previous consumption patterns and to participate at a group dealing with the topic
4. Informed consent of participants and in the case of underage participants the informed consent of a parent or official guardian

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

n = 119

Participant exclusion criteria

Acute symptoms of psychosis or suicidality. These exclusion criteria were checked via standardised screening questions at the beginning of the face-to-face take-in talks at the respective cooperation partner's institutions.

Recruitment start date

15/02/2011

Recruitment end date

31/10/2011

Locations

Countries of recruitment

Germany

Trial participating centre

DZSKJ
Hamburg
20246
Germany

Sponsor information

Organisation

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)

Sponsor details

Division Addiction and Drugs
Friedrichstrasse 108
Berlin
10117
Germany
albert.kern@bmg.bund.de

Sponsor type

Government

Website

http://www.bmg.bund.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: AZ IIA5-2507DSM209)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Medical Centre Hamburg-Eppendorf (Germany) - German Centre for Addiction Research in Children and Adolescents

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Rostock (Germany) - Department for Child and Adolescent Psychiatry

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

Publication citations

Additional files

Editorial Notes