Condition category
Mental and Behavioural Disorders
Date applied
07/04/2011
Date assigned
25/05/2011
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.familien-staerken.info

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 measures

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

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24467917

Publication citations

  1. 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.

Additional files

Editorial Notes