Clinical trial NCT05257642: Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity
Official title: Testing the Usability of the REThink Game and the Efficacy of Its Main Game-based ER Strategies on the Stress Reactivity of Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2022-02-25
Enrollment: 146
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents

Detailed description: Children included in this study (aged 8-16 years, G\*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.

Eligibility criteria: Inclusion Criteria:

children and adolescents between 8 and 16 years provided written parental consent

Exclusion Criteria:

Intellectual disability or physical limitations precluded the use of the computer program

Primary outcomes:
measure: Levels of rational and irrational beliefs
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in rational and irrational beliefs
timeFrame: Post-intervention (one week afterthe intervention)
measure: Levels of mindfulness
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in levels of mindfulness
timeFrame: Post-intervention (one week afterthe intervention)
measure: Levels of well-being
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in levels of well-being
timeFrame: Post-intervention (one week afterthe intervention)
measure: Levels of emotion-regulation
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in levels of emotion-regulation
timeFrame: Post-intervention (one week afterthe intervention)
measure: Level of distress
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in level of distress
timeFrame: Post-intervention (one week afterthe intervention)
measure: Children Emotional Abilities
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in children Emotional Abilities
timeFrame: Post-intervention (one week afterthe intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Oana David, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: