Study aims and benefits
The START training for research will be tested for efficacy in a randomized-controlled design with both primary/co-primary endpoints of the Perceived Stress Scale PSS-10 and Impact of Events Scale Revised (IES-R). To analyze the primary hypothesis, a mixed linear regression model will be used with the difference at 8 weeks and baseline of the PSS-10 and IES-R, respectively, as the outcome variable. In addition, the stability of the intervention effect will be tested at a catamanesis time point 24 weeks after intervention (including booster session).
Additional study information
START is a low-threshold and culturally integrative stabilization concept for children and adolescents with severe stress experiences, trauma sequelae and severe emotional stress. The structured therapy manual "START" was developed in the context of practical work with unaccompanied minor refugees in clearing and initial reception contexts and in the clinical care of child and adolescent psychiatry in Idar-Oberstein.
The START program will be tested for effectiveness in a larger randomized-controlled approach with more rigorous scientific framing and an adequate control group.
Primary endpoint:
- Reduction in stress experience as measured by the PSS-10 (Perceived Stress Scale) from baseline measurement to completion of the intervention (T1) relative to the wait-list control group.
Co-primary endpoint:
- Reduction in post-traumatic symptoms measured with the IES-R (Impact of Event Scale) between baseline and completion of the intervention (T1) relative to the wait-list control group.
Study procedures
If you would like to participate in the study, we will first make two appointments with you. At these meetings (= screening) you will receive further information and fill out questionnaires together with us. In this way we want to check whether the training is suitable for you. If you meet the conditions and want to participate, it will be decided at random whether you can start the START training directly (intervention group/immediate group) or whether you have to wait a few more weeks (waiting control group).
The START training lasts 8 weeks: the sessions take place twice a week and last one hour each. 4 weeks after the end of the program there will be another session to refresh what we have learned.
Before and after the START training, you will also be asked to fill out questionnaires about, for example, your emotions or your opinion of the program. In this way, we want to check whether the program is helpful.
You can also see the exact procedure of the study in the figure
Waiting control group: max. 1-2 weeks after randomization
Waiting control group: 8 weeks waiting time
Waiting control group: 8 weeks waiting time
Contact
M.Sc. Nicole Fischer
Nicole.fischer@unimedizin-mainz.de
+49 6131 378 12352
Coordinators
Head: Univ.-Prof. Dr. med. Dipl.-Psych. Michael Huss