The Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents

Interpersonal Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04808102
• Other study ID #: DOT2021P1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: March 2022

Study information

• Verified date: February 2021
• Source: Karl Landsteiner University of Health Sciences
• Contact: Gloria Mittmann, MSc
• Phone: +43 (0) 664 882 857 69
• Email: gloria.mittmann[@]kl.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Interpersonal Relations

Intervention

Device:
• IER AG
The game is a web-based single-player adventure game with 3 levels created with the RPG Maker MV. Playtime is approximately 3 hours.
• BubbleShooter
A free-to-play arcade browser puzzle game called BubbleShooter.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karl Landsteiner University of Health Sciences	Ludwig Boltzmann Gesellschaft

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interpersonal emotion regulation	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.	The follow-up will be approximately 5 days after baseline measures.