Evaluation of the German adaptation of the US-American family based prevention program against substance abuse, "Strengthening Families Program 10-14"
| ISRCTN | ISRCTN90251787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90251787 |
| Secondary identifying numbers | 01EL0810 |
- Submission date
- 07/04/2011
- Registration date
- 25/05/2011
- Last edited
- 30/09/2014
- 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
Dr Martin Stolle
Scientific
Scientific
Martinistr. 52
Hamburg
20246
Germany
| m.stolle@uke.de |
Study information
| Study design | Controlled randomized longitudinal and cross-sectional study |
|---|---|
| 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 | Randomized controlled multicenter evaluation of the German adaptation of the US-American family based prevention program against substance abuse "Strengthening Families Program 10-14" |
| Study objectives | 1. Adolescents who attend the adapted German version of "Strengthening Families Program 10-14" will significantly later begin the consumption of tobacco, alcohol and cannabis. 2. On average, adolescents in the intervention group will consume less of these substances than the controls group 3. Adolescents from the intervention group will manifest less behavioural problems in school and at home than controls |
| Ethics approval(s) | Medical Association of Hamburg, Germany |
| Health condition(s) or problem(s) studied | Substance abuse and behavioural disorders in adolescents |
| Intervention | Intervention: 1. The German version of the Strengthening Families Program 10-14, now called Familien stärken consists of 11 training sessions which last two hours each 2. The first 7 sessions are held weekly, followed by a pause of 2-3 months. 3. Then, another 4 booster sessions are held weekly 4. Up to nine families with their children aged 11-13 take part in the intervention 5. The groups are led by 3 facilitators who have a degree in social education 6. During the first hour of the training, parents and adolescents are separated and attend individual groups 7. In the second hour, families are reunited for the family session 8. The program aims at improving adolescents self-efficacy, coping with stress and with peer pressure 9. Parents are encouraged to reflect their education style, to develop a more consistent form of parenting and to express positive affect more openly 10. Dysfunctional communication patterns within the family are addressed and family cohesiveness is strengthened Control: 1. Parents gather for a single session which lasts 2 ½ hours 2. Here, parents learn about adolescents and substance abuse and about ways to improve their parenting styles Pre and post intervention assessments and follow-ups after 6, 12, and 18 months |
| Intervention type | Other |
| Primary outcome measure | 1. Adolescents substance consumption 2. Adolescents mental health status 3. Adolescents self-efficacy 4. Adolescents problem behaviour 5. Parenting style 6. Level of family functioning 7. Measuring points for both arms are at baseline, post intervention (after the booster sessions), as well as 6 and 18 months after the intervention ended (follow ups) |
| Secondary outcome measures | 1. Parents mental health status 2. Parents self-efficacy 3. Parents' self-efficacy in parenting |
| Overall study start date | 01/03/2010 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 288 |
| Key inclusion criteria | 1. Age range from 11-13 2. Living in an economically deprived area of a city 3. The capability to attend group programs |
| Key exclusion criteria | 1. A diagnosed substance abuse disorder 2. Currently participating or having participated in the past six months in another comparable prevention program |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 31/03/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
Martinistr. 52
Hamburg
20246
Germany
20246
Germany
Sponsor information
German Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF)] (Germany)
Government
Government
c/o German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt; DLR)
Heinrich-Konen-Str. 1
Bonn
53227
Germany
| Phone | +49 228 3821 0 |
|---|---|
| Nathalie.dommel@dlr.de | |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (BMBF), ref: 01EL0810.
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/01/2014 | Yes | No |
