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

March 18, 2021 updated by: Karl Landsteiner University of Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The follow-up will be approximately 5 days after baseline measures.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Landsteiner University of Health Sciences

Collaborators

Ludwig Boltzmann Gesellschaft

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DOT2021P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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