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Completed

NCT Number: NCT05424601

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

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

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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Self-Control Social Behavior

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rethink game

Behavioral

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.

PsyPills

Behavioral

PsyPills is a mobile app designed to provide personalized psychological pills

Primary outcomes

  1. Levels of rational and irrational beliefs

    Time frame: Baseline

    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")

  2. Changes in levels of rational and irrational beliefs

    Time frame: Post-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")

  3. Emotion regulation abilities

    Time frame: Baseline

    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.

  4. Changes in emotion regulation abilities

    Time frame: Post-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.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

  • The Executive Agency for Higher Education, Research, Development and Innovation Funding

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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