Clinical trial NCT04808102: The Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents
Official title: Randomized Controlled Trial to Evaluate the Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interpersonal Relations
Keywords: interpersonal emotion regulation
serious games
early adolescence
Lead sponsor: Karl Landsteiner University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Gesellschaft
First posted: 2021-03-22
Enrollment: 180
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a RCT with an experimental and a control group, with participants being individually allocated to either of the groups. The allocation ratio is 50:50. This RCT adopts a pre-post-test strategy with the between-participant factor "group" and the within-participant factor "time".
Primary purpose: PREVENTION

Brief summary: 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 early adolescents specifically.

Methods: This randomized 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 assessed by a vignette task is the primary outcome variable and will be analysed with a chi-square test. Feasibility and acceptability and variables such as emotional competence, personal emotion regulation, gender, and sex will be assessed by questionnaires.

Discussion: This RCT will test whether playing serious game about iER strategies will result 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 school classes and help early adolescents achieve positive peer relationships.


Eligibility criteria: Inclusion Criteria:

* Between 10 and 14 years old
* Willing and able to provide written parental consent
* Willing and able to participate in filling out pre- and post-test online questionnaires, and playing a web-based game
* Able to read and understand German or English
* Access to a device with internet (computer, mobile phone, tablet)

Exclusion Criteria:

-

Primary outcomes:
measure: Interpersonal emotion regulation
timeFrame: The follow-up will be approximately 5 days after baseline measures.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karl Landsteiner University of Health Sciences
name: Beate Schrank
role: STUDY_DIRECTOR
References:
citation: Mittmann G, Zehetmayer S, Schrank B. Study protocol for a randomised controlled trial to evaluate the effectiveness of a serious game targeting interpersonal emotion regulation in early adolescents. Trials. 2021 Oct 25;22(1):741. doi: 10.1186/s13063-021-05706-7.