Background: The trial YOURTREAT aims to compare the pragmatic, short-term psychotherapy Narrative Exposure Therapy for Children (KIDNET) with treatment as usual (TAU) for the treatment of young refugees in Germany. This update outlines changes made to the study protocol in response to the current COVID-19 pandemic with the aim of allowing the continuation of the clinical trial while ensuring the safety of the staff and the participants, maintaining methodological quality, and ensuring compliance with legal regulations.
Methods: The major amendments to the original study protocol include (1) the possibility of using telehealth technology for the conduction of diagnostic and therapy sessions, (2) a reduction of the diagnostic set, and (3) an increased flexibility in the time frame of the study protocol.
Discussion: The adaptations to the study protocol made it feasible to continue with the trial YOURTREAT during the COVID-19 pandemic. Although the diagnostic set had to be shortened, the primary outcomes and the main secondary outcomes remain unimpaired by the amendment. Therefore, we expect the trial to provide evidence regarding effective treatment options for young refugees in Germany, a population that has received little scientific attention so far and has only very limited access to mental health care in the German health care system. In light of the current pandemic, which globally increases the risk of mental problems, the situation for young refugees is likely to aggravate further. Thus, the clinical and social relevance of the present trial YOURTREAT is even more important in these particular times.
Trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00017222 . Registered on May 15, 2019.
Keywords: Adolescents; Children; Narrative Exposure Therapy for Children (KIDNET); Post-traumatic stress disorder; Randomized controlled trial; Refugees.
© 2022. The Author(s).