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

NCT04808102 | Unknown

• 1 other identifier: DOT2021P1
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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

Keywords

interpersonal emotion regulation; serious games; early adolescence

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

IER serious game

EXPERIMENTAL

A serious game training interpersonal emotion regulation strategies.

Device: IER AG

control game

SHAM COMPARATOR

A control puzzle game without psychoeducational content.

Device: BubbleShooter

Interventions

IER AG 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.

IER serious game

BubbleShooter DEVICE

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

control game

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• Ludwig Boltzmann Gesellschaft: collaborator

Related Publications (1)

• 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.

  PMID: 34696816 DERIVED

Study Officials

• Beate Schrank

  Karl Landsteiner University of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Gloria Mittmann, MSc

CONTACT

+43 (0) 664 882 857 69; gloria.mittmann@kl.ac.at

Beate Schrank

CONTACT

beate.schrank@kl.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share