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

Emotion Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424601
• Other study ID #: RETthinkEMOTIONS3
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: September 2022
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 7, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Behavioral:
• Rethink 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.
• PsyPills
PsyPills is a mobile app designed to provide personalized psychological pills

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (2)

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

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of rational and irrational beliefs	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")	Baseline
Primary	Changes in levels of rational and irrational beliefs	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")	Post-intervention (one week after the intervention)
Primary	Levels of emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	Baseline
Primary	Changes in levels of emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	Post-intervention (one week after the intervention)
Primary	Level of distress	Measured with Profile of Emotional Distress	Post-intervention (one week after the intervention)
Primary	Emotion regulation abilities	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.	Baseline
Primary	Changes in emotion regulation abilities	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.	Post-intervention (one week after the intervention)
Primary	Reflective functioning	The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.	Baseline
Primary	Changes in reflective functioning	The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.	Post-intervention (one week after the intervention)