The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: update to the study protocol for the multi-center randomized controlled trial YOURTREAT.
Adolescents
Children
Narrative Exposure Therapy for Children (KIDNET)
Post-traumatic stress disorder
Randomized controlled trial
Refugees
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 Apr 2022
27 Apr 2022
Historique:
received:
14
02
2022
accepted:
07
04
2022
entrez:
28
4
2022
pubmed:
29
4
2022
medline:
30
4
2022
Statut:
epublish
Résumé
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. 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. 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. German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00017222 . Registered on May 15, 2019.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00017222 . Registered on May 15, 2019.
Identifiants
pubmed: 35477413
doi: 10.1186/s13063-022-06288-8
pii: 10.1186/s13063-022-06288-8
pmc: PMC9044372
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
360Subventions
Organisme : Bundesministerium für Bildung und Forschung
ID : 01GL1749C
Informations de copyright
© 2022. The Author(s).
Références
Trials. 2020 Feb 14;21(1):185
pubmed: 32059695
J Affect Disord. 2020 Dec 1;277:55-64
pubmed: 32799105
J Affect Disord. 2021 Feb 1;280(Pt A):407-408
pubmed: 33227670
Trials. 2021 Jan 18;22(1):62
pubmed: 33461595