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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04808102
Other study ID # DOT2021P1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2021
Est. completion date March 2022

Study information

Verified date February 2021
Source Karl Landsteiner University of Health Sciences
Contact Gloria Mittmann, MSc
Phone +43 (0) 664 882 857 69
Email gloria.mittmann@kl.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date March 2022
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Karl Landsteiner University of Health Sciences Ludwig Boltzmann Gesellschaft

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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