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

NCT ID: NCT04808102

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-03-31

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.

Conditions

Interpersonal Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

IER serious game

A serious game training interpersonal emotion regulation strategies.

Group Type: EXPERIMENTAL

IER AG

Intervention Type: DEVICE

The game is a web-based single-player adventure game with 3 levels created with the RPG Maker MV. Playtime is approximately 3 hours.

control game

A control puzzle game without psychoeducational content.

Group Type: SHAM_COMPARATOR

BubbleShooter

Intervention Type: DEVICE

A free-to-play arcade browser puzzle game called BubbleShooter.

Interventions

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.

Intervention Type: DEVICE

BubbleShooter

A free-to-play arcade browser puzzle game called BubbleShooter.

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ludwig Boltzmann Gesellschaft

OTHER

Sponsor Role: collaborator

Karl Landsteiner University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beate Schrank

Role: STUDY_DIRECTOR

Karl Landsteiner University of Health Sciences

Central Contacts

Gloria Mittmann, MSc

Role: CONTACT

gloria.mittmann@kl.ac.at

+43 (0) 664 882 857 69

Beate Schrank

Role: CONTACT

beate.schrank@kl.ac.at

References

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.

Reference Type: DERIVED

PMID: 34696816 (View on PubMed)

Other Identifiers

DOT2021P1

Identifier Type: -

Identifier Source: org_study_id