- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808102
The Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gloria Mittmann, MSc
- Phone Number: +43 (0) 664 882 857 69
- Email: gloria.mittmann@kl.ac.at
Study Contact Backup
- Name: Beate Schrank
- Email: beate.schrank@kl.ac.at
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Collaborators
Investigators
- Study Director: Beate Schrank, Karl Landsteiner University of Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DOT2021P1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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