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
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