Safety and ethical aspects of the FIAT study

Great importance is placed on minimising potential risks in the FIAT study, to ensure the safety of all study participants. The study is being conducted in accordance with the Declaration of Helsinki, which are ethical principles in medical research involving humans. Ethical approval has been obtained from a designated research ethics committee to ensure that the FIAT study meets the highest ethical standards.

 

However, the following burdens or risks may arise:

 

• FBT^SCM may be inferior to SMT.  
• In families receiving FBT^SCM, parents are required to be actively involved, which involves a significant time commitment.  
• Especially in the early stages, FBT^SCM can be emotionally challenging and stressful for patients and their families due to illness-related factors (e.g., the fear of weight gain).
• If weight goals are not achieved or other crises occur, patients treated with FBT^SCM may require a short hospital stay to ensure medical stability.  
• In special cases, such as severe psychiatric crises, FBT^SCM may have to be stopped.

 

 

The study is based on the following ethical safeguards:

Before the study begins, all families receive detailed information and potential risks are discussed in further depth. In addition, a comprehensive initial examination is carried out by experienced study physicians. This includes a physical examination, psychological assessment and medical tests such as an ECG or blood tests. The FBT^SCM only begins once medical and psychiatric stability is guaranteed, all participants voluntarily decide to take part in the study and the consent forms have been signed.

 

During FBT^SCM, patients are monitored by a doctor. The frequency of the examinations depends on the weight development. The results of these tests are discussed with the families.

 

If medical or psychiatric instability arises, inpatient stabilisation takes place for a maximum of six weeks, preferably in the clinic originally intended for inpatient therapy. FBTSCM can then be continued. If FBTSCM does not lead to the desired outcomes after a maximum of two attempts, FBTSCM is terminated and a transfer to regular inpatient care with subsequent outpatient treatment is initiated. However, study outcome measures will still be collected at the main time-points, as this is the only way to obtain a complete picture of the long-term effectiveness of FBTSCM even after its termination.

 

Therapeutic quality assurance

All FBT^SCM therapists are appropriately trained and certified or are undergoing certified specialist training. Regular case supervision and interdisciplinary team visits ensure the high quality of FBT^SCMdelivery. Critical developments are recognised at an early stage, discussed in the supervision and consultation sessions and appropriate actions are initiated. Therapy sessions are also video-recorded, and 5% are analysed at the end of the study to verify that the therapeutic approach is in accordance with the therapy manual.

 

Data protection

All personal data are treated in strict confidence and processed in accordance with applicable data protection laws.