Condition category
Mental and Behavioural Disorders
Date applied
06/05/2010
Date assigned
22/07/2010
Last edited
22/07/2010
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

Dr Reiner Hanewinkel

ORCID ID

Contact details

IFT-Nord
Harmsstr. 2
Kiel
24114
Germany
+49 (0)431 570 2920
hanewinkel@ift-nord.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

108374

Study information

Scientific title

A school-based substance use prevention programme based on the Social Influence Approach: a prospective cluster randomised controlled trial

Acronym

Study hypothesis

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

Ethics Board of Medical Faculty of Christian Albrechts University Kiel, Germany, approved on the 23rd April 2010 (ref: D419/10)

Study design

Prospective cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/05/2010

Overall trial end date

15/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Students of public schools
2. Aged between 10 and 12 years (grade 5 to 6), either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3160 students (in 158 classes)

Participant exclusion criteria

1. Students of schools with special pedagogic needs
2. Missing consent of school
3. Missing parental consent

Recruitment start date

01/05/2010

Recruitment end date

15/01/2014

Locations

Countries of recruitment

Germany

Trial participating centre

IFT-Nord
Kiel
24114
Germany

Sponsor information

Organisation

German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)

Sponsor details

Buschstr. 32
Bonn
53113
Germany

Sponsor type

Charity

Website

http://www.krebshilfe.de

Funders

Funder type

Charity

Funder name

German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany) (ref: 108374)

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