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Clinical Trials/NCT04808102
NCT04808102
Unknown
Not Applicable

Randomized Controlled Trial to Evaluate the Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents

Karl Landsteiner University of Health Sciences0 sites180 target enrollmentApril 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interpersonal Relations
Sponsor
Karl Landsteiner University of Health Sciences
Enrollment
180
Primary Endpoint
Interpersonal emotion regulation
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2021
End Date
March 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karl Landsteiner University of Health Sciences
Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Interpersonal emotion regulation

Time Frame: The follow-up will be approximately 5 days after baseline measures.

change of iER strategies participants can think of from pre (baseline)- to post-intervention, i.e. if the percentage of participants who improve their knowledge about possible iER strategies is higher in the experimental group compared to the control group. This is done via a vignette-task.

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