Interpersonal RelationsNCT04808102
The Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents
A study testing IER AG and BubbleShooter in people with Interpersonal Relations, run by Karl Landsteiner University of Health Sciences.
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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Relations
- What is being tested?
- IER AG and BubbleShooter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Beate Schrank contact
About this study
Official title: 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.
- Conditions
- Interpersonal Relations
- Being tested
- IER AG, BubbleShooter
- Keywords
- interpersonal emotion regulation, serious games, early adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IER AGDevice
The game is a web-based single-player adventure game with 3 levels created with the RPG Maker MV. Playtime is approximately 3 hours.
BubbleShooterDevice
A free-to-play arcade browser puzzle game called BubbleShooter.
| Study group | Role | What they receive |
|---|---|---|
| IER serious game | Experimental | A serious game training interpersonal emotion regulation strategies. Receives: Device: IER AG |
| control game | Sham comparator | A control puzzle game without psychoeducational content. Receives: Device: BubbleShooter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The follow-up will be approximately 5 days after baseline measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interpersonal RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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".
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Gesellschaft
- Responsible party
- Sponsor
- Investigators
- Beate Schrank, Study director, Karl Landsteiner University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808102
- Sponsor's protocol ID
- DOT2021P1
- Status last verified
- Feb 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34696816
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents
- ClinicalTrials.gov ID
- NCT04808102
- Acronym / sponsor ID
- DOT2021P1
- Conditions
- Interpersonal Relations
- Keywords
- interpersonal emotion regulation, serious games, early adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Gesellschaft
- Study start
- Apr 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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".
| Arm | Type | Receives |
|---|---|---|
| IER serious game | Experimental | Device: IER AGA serious game training interpersonal emotion regulation strategies. |
| control game | Sham comparator | Device: BubbleShooterA control puzzle game without psychoeducational content. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IER AGThe game is a web-based single-player adventure game with 3 levels created with the RPG Maker MV. Playtime is approximately 3 hours. | Device | IER serious game |
| BubbleShooterA free-to-play arcade browser puzzle game called BubbleShooter. | Device | control game |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 34696816Mittmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Schrank contact
Beate Schrank study director
Karl Landsteiner University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing IER AG and BubbleShooter in people with Interpersonal Relations, run by Karl Landsteiner University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Mittmann, MSc (+43 (0) 664 882 857 69, gloria.mittmann@kl.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpersonal emotion regulation (time frame: The follow-up will be approximately 5 days after baseline measures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04808102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.