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Intervention in a Small-scale Study of Game Based Cognitive Change Skills

Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching with or Without EMI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05424601
Enrollment
165
Registered
2022-06-21
Start date
2022-06-10
Completion date
2022-09-07
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotion Regulation

Keywords

online therapeutic game, emotional problems, emotional regulation, children and adolescents

Brief summary

This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

Detailed description

Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.

Interventions

BEHAVIORALRethink game

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

BEHAVIORALPsyPills

PsyPills is a mobile app designed to provide personalized psychological pills

Sponsors

The Executive Agency for Higher Education, Research, Development and Innovation Funding
CollaboratorOTHER
Babes-Bolyai University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* children and adolescents between 10 and 16 years old * provided written parental consent * able to access mobile/internet applications on their device

Exclusion criteria

* Intellectual disability or physical limitations precluded the use of the computer program * Had a major mental health disorder

Design outcomes

Primary

MeasureTime frameDescription
Changes in levels of rational and irrational beliefsPost-intervention (one week after the intervention)The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 (strong disagreement) to 5 (strong agreement)
Emotion regulation abilitiesBaselineThe Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Changes in emotion regulation abilitiesPost-intervention (one week after the intervention)The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Levels of rational and irrational beliefsBaselineThe Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 (strong disagreement) to 5 (strong agreement)

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026