"Be Independent (Eigenständig werden)" prevention trial: a school-based substance use prevention programme based on the Social Influence Approach

ISRCTN	ISRCTN99442407
DOI	https://doi.org/10.1186/ISRCTN99442407
Protocol serial number	108374
Sponsor	German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
Funder	German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany) (ref: 108374)

Submission date: 06/05/2010
Registration date: 22/07/2010
Last edited: 29/12/2020

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Reiner Hanewinkel
Scientific

IFT-Nord
Harmsstr. 2
Kiel
24114
Germany

Phone	+49 (0)431 570 2920
Email	hanewinkel@ift-nord.de

Study information

Primary study design	Interventional
Study design	Prospective cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A school-based substance use prevention programme based on the Social Influence Approach: a prospective cluster randomised controlled trial
Study objectives	Participation in the prevention programme "Eigenständig werden" leads to higher social and personal competencies, lower rates of substance use and initiation, better knowledge on substance use, lower susceptibilitiy to smoking and alcohol and more negative attitudes towards substances.
Ethics approval(s)	Ethics Board of Medical Faculty of Christian Albrechts University Kiel, Germany, approved on the 23rd April 2010 (ref: D419/10)
Health condition(s) or problem(s) studied	Tobacco and alcohol dependance
Intervention	"Eigenständig werden" (Becoming independent) is a school-based life skill programme with substance specific units and information of parents. Trained teachers implement 9 units school year. In the contol group, classes receive treatment as usual (normal school lessons).
Intervention type	Other
Primary outcome measure(s)	1. Life skills, social and interpersonal competencies 2. Smoking and alcohol use behaviour (lifetime, current) and intentions These will be measured at baseline, post-test 1 (end of grade 5), post-test 2 (end of grade 6), 6 and 18 months follow-up.
Key secondary outcome measure(s)	1. Knowledge on smoking and alcohol 2. Attitudes on smoking and alcohol These will be measured at baseline, post-test 1 (end of grade 5), post-test 2 (end of grade 6), 6 and 18 months follow-up.
Completion date	15/01/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	3160
Total final enrolment	3444
Key inclusion criteria	1. Students of public schools 2. Aged between 10 and 12 years (grade 5 to 6), either sex
Key exclusion criteria	1. Students of schools with special pedagogic needs 2. Missing consent of school 3. Missing parental consent
Date of first enrolment	01/05/2010
Date of final enrolment	15/01/2014

Locations

Countries of recruitment

Germany

Study participating centre

IFT-Nord

Kiel
24114
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?
Results article	6-month follow-up results	21/01/2014	29/12/2020	Yes	No
Results article	results	01/01/2011	29/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.