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

Not Applicable

Completed

• Conditions: Emotion Regulation
• Interventions: Behavioral: Rethink game; Behavioral: PsyPills

• Registration Number: NCT05424601
• Lead Sponsor: Babes-Bolyai University

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.

Study Timeline

• Study Start: 2022-06-10
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Primary Completion: 2022-09-05
• Study Completion: 2022-09-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rethink Game	Rethink game	Rethink game only
Rethink game plus PsyPills	Rethink game	Rethink game followed by PsyPills
Rethink game plus PsyPills	PsyPills	Rethink game followed by PsyPills

Primary Outcome Measures

Name	Time	Method
Emotion regulation abilities	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.
Changes in emotion regulation abilities	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.
Levels of rational and irrational beliefs	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")
Changes in levels of rational and irrational beliefs	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")

Trial Locations

Locations (1)

Babes-Bolyai University; 🇷🇴 Cluj-Napoca, Cluj, Romania