Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

Not Applicable

Completed

• Conditions: Emotional Regulation
• Interventions: Other: REThink Game; Other: MoodWheel; Other: PsyPills

• Registration Number: NCT06085391
• Lead Sponsor: Babes-Bolyai University

Brief Summary

This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-06
• Study Start: 2023-10-07
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-17
• Primary Completion: 2023-11-10
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• children and adolescents between 8 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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PsyPills	REThink Game	Participants from experimental group who do not respond to REThink game alone will receive the PsyPills app
REThink game	REThink Game	Each recruited participant randomized in the experimental group will receive the REThink game app.
MoodWheel	MoodWheel	The participants randomized in the control group will complete the MoodWheel app.
PsyPills	PsyPills	Participants from experimental group who do not respond to REThink game alone will receive the PsyPills app

Primary Outcome Measures

Name	Time	Method
Fluctuations in emotion-regulation	6 months Follow-up	The Emotion Regulation Index for Children and Adolescents (ERICA). 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,
Fluctuations in child behavioral difficulties	6 months follow-up	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.
Levels of rational and irrational beliefs	baseline, pre-intervention	The Child and Adolescent Scale of Irrationality 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 of rational and irrational beliefs	Post-intervention (one week after the intervention)	The Child and Adolescent Scale of Irrationality 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")
Fluctuations in of rational and irrational beliefs	6 months Follow-up	The Child and Adolescent Scale of Irrationality 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")
Levels of child behavioral difficulties	Pre-intervention (one week before the intervention)	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.
Changes in child behavioral difficulties	Post-intervention (one week after the intervention)	Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.
Levels of emotion-regulation	baseline, pre-intervention	The Emotion Regulation Index for Children and Adolescents (ERICA) 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,
Changes in emotion-regulation	Post-intervention (one week after the intervention)	The Emotion Regulation Index for Children and Adolescents (ERICA). 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,

Secondary Outcome Measures

Name	Time	Method
Level of emotional distress	baseline, pre-intervention	The Profile of Emotional Distress (PED) is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).
Changes in emotional distress	Post-intervention (one week after the intervention)	The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).
Fluctuations in emotional distress	6 months follow-up	The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).

Trial Locations

Locations (1)

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