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

Sponsor

Karl Landsteiner University of Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04808102

Collaborator

Ludwig Boltzmann Gesellschaft (Other)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interpersonal Relations	Device: IER AG Device: BubbleShooter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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".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".

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Investigator and trial participants will be blinded throughout the study due to the automised randomization process via the online server SosciSurvey. Statistical analysis will be executed by generating a number for each group, with its affiliation unknown to the analyst.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IER serious game A serious game training interpersonal emotion regulation strategies.	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.
Sham Comparator: control game A control puzzle game without psychoeducational content.	Device: BubbleShooter A free-to-play arcade browser puzzle game called BubbleShooter.

Arm

Intervention/Treatment

Experimental: IER serious game

A serious game training interpersonal emotion regulation strategies.

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.

Sham Comparator: control game

A control puzzle game without psychoeducational content.

Device: BubbleShooter

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

Outcome Measures

Primary Outcome Measures

Interpersonal emotion regulation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karl Landsteiner University of Health Sciences
Ludwig Boltzmann Gesellschaft

Investigators

Study Director: Beate Schrank, Karl Landsteiner University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karl Landsteiner University of Health Sciences

ClinicalTrials.gov Identifier:

NCT04808102

Other Study ID Numbers:

DOT2021P1

First Posted:

Mar 22, 2021

Last Update Posted:

Mar 22, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karl Landsteiner University of Health Sciences

interpersonal emotion regulation

serious games

early adolescence

Study Results

No Results Posted as of Mar 22, 2021