CAN Stop - psychoeducation and relapse prevention for young persons with problematic cannabis use

ISRCTN	ISRCTN57036983
DOI	https://doi.org/10.1186/ISRCTN57036983
Protocol serial number	IIA5-2507DSM209
Sponsor	German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)
Funders	German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: AZ IIA5-2507DSM209), University Medical Centre Hamburg-Eppendorf (Germany) - German Centre for Addiction Research in Children and Adolescents, University of Rostock (Germany) - Department for Child and Adolescent Psychiatry

Submission date: 18/01/2011
Registration date: 10/03/2011
Last edited: 18/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rainer Thomasius
Scientific

DZSKJ
Martinistrasse 52
Hamburg
20246
Germany

Email	thomasius@uke.uni-hamburg.de

Study information

Primary study design	Interventional
Study design	Four-arm randomised wait-list controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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]
Study acronym	CAN Stop
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	119
Key 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
Key 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.
Date of first enrolment	15/02/2011
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

Germany

Study participating centre

DZSKJ

Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/04/2011	18/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2020: Publication reference added.