"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 |
| Secondary identifying numbers | 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
Scientific
IFT-Nord
Harmsstr. 2
Kiel
24114
Germany
| Phone | +49 (0)431 570 2920 |
|---|---|
| hanewinkel@ift-nord.de |
Study information
| Study design | Prospective cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2010 |
| Completion date | 15/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 3160 students (in 158 classes) |
| 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
24114
Germany
Sponsor information
German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
Charity
Charity
Buschstr. 32
Bonn
53113
Germany
| Website | http://www.krebshilfe.de |
|---|---|
"ROR" |
https://ror.org/01wxdd722 |
Funders
Funder type
Charity
German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany) (ref: 108374)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
