Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Martin Stolle
ORCID ID
Contact details
Martinistr. 52
Hamburg
20246
Germany
m.stolle@uke.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01EL0810
Study information
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"
Acronym
Study hypothesis
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
Medical Association of Hamburg, Germany
Study design
Controlled randomized longitudinal and cross-sectional study
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
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
Phase
Not Applicable
Drug names
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 trial start date
01/03/2010
Overall trial end date
31/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
288
Participant exclusion criteria
1. A diagnosed substance abuse disorder
2. Currently participating or having participated in the past six months in another comparable prevention program
Recruitment start date
01/03/2010
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Martinistr. 52
Hamburg
20246
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF)] (Germany)
Sponsor details
c/o German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt; DLR)
Heinrich-Konen-Str. 1
Bonn
53227
Germany
+49 228 3821 0
Nathalie.dommel@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (BMBF), ref: 01EL0810.
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24467917
Publication citations
-
Protocol
Bröning S, Sack PM, Thomsen M, Stolle M, Wendell A, Stappenbeck J, Thomasius R, Implementing and evaluating the German adaptation of the "Strengthening Families Program 10 - 14"- a randomized-controlled multicentre study., BMC Public Health, 2014, 14, 83, doi: 10.1186/1471-2458-14-83.