@article{dab5ca929a444a31a424d5219840288f,
title = "Study protocol for a randomised controlled trial to evaluate the effectiveness of a serious game targeting interpersonal emotion regulation in early adolescents",
abstract = "BACKGROUND: Adaptive interpersonal emotion regulation (iER) is a vital tool for positive relations. During early adolescence, peer relations become increasingly important, making this age group a relevant target group for interventions promoting positive interactions with each other, yet no evidence-based intervention exists for iER and early adolescents specifically.METHODS: This randomised controlled trial (RCT) aims to test effectiveness and feasibility of a serious game training iER skills in early adolescents by comparing outcomes with a control group playing a game without psychoeducational content in a pre- and post-test design. German- and English-speaking early adolescents (10-14 years) are eligible for participation. IER skills improvement as assessed by a vignette task is the primary outcome and will be analysed with a chi-square test. Secondary outcomes include feasibility and acceptability, emotional competence, personal emotion regulation, gender, and sex.DISCUSSION: This RCT will test whether playing a serious game about iER strategies results in an improvement of iER skills and whether the game is feasible and acceptable for early adolescents with the ultimate aim to implement the game in schools and help early adolescents achieve positive peer relationships.TRIAL REGISTRATION: ClinicalTrials.gov NCT04808102 , Registered on 19 March 2021.",
keywords = "Adolescent, Adolescent Behavior, Emotional Regulation, Humans, Interpersonal Relations, Peer Group, Randomized Controlled Trials as Topic, Schools",
author = "Gloria Mittmann and Sonja Zehetmayer and Beate Schrank",
note = "Funding Information: The D.O.T. (Die Offene T{\"u}r - The Open Door) team of co-investigators - Adam Barnard (playwright and theatre director), Jo{\~a}o Dias (computer scientist), Marija Mitic (medical doctor and researcher), Beate Schrank (practicing & research psychiatrist), and Kate Woodcock (research psychologist) - grew during a sandpit event (Ideas Lab) organized by the Open Innovation Center of Ludwig Boltzmann Society and facilitated by Know Innovation. The team would like to thank these organisations for their role in its formation. D.O.T teamwork is jointly conceived and led by the co-investigators. The team sees this as a fully meaningful interdisciplinary collaboration. We would also like to thank Professor Karen Niven for providing material from her original study that helped develop the game that is the main intervention in this protocol. GM is the main investigator; she conceived the study and led the protocol development. SZ is responsible for the statistical analysis plan of the data. BS supervised the process throughout and contributed to all aspects of the study and protocol development. All authors read and approved the final manuscript. This work is supported by the Ludwig Boltzmann Society and the Karl-Landsteiner University of Health Sciences. The funding body has no role in the design of the study, analysis, or interpretation of the data. We acknowledge support by Open Access Publishing Fund of Karl Landsteiner University of Health Sciences, Krems, Austria. The study team will have access to the final trial dataset; currently, there are no other contractual agreements. Funding Information: This work is supported by the Ludwig Boltzmann Society and the Karl-Landsteiner University of Health Sciences. The funding body has no role in the design of the study, analysis, or interpretation of the data. We acknowledge support by Open Access Publishing Fund of Karl Landsteiner University of Health Sciences, Krems, Austria. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
doi = "10.1186/s13063-021-05706-7",
language = "English",
volume = "22",
pages = "741",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",
number = "1",
}