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

NCT06085391 | Completed

• 1 other identifier: REThink SMARTrial
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Regulation

Outcome Measures

Primary Outcomes (9)

• Levels of rational and irrational beliefs

  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")

  baseline, pre-intervention

• Changes of rational and irrational beliefs

  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")

  Post-intervention (one week after the intervention)

• Fluctuations in of rational and irrational beliefs

  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")

  6 months Follow-up

• Levels of emotion-regulation

  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,

  baseline, pre-intervention

• Changes in emotion-regulation

  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,

  Post-intervention (one week after the intervention)

• Fluctuations in emotion-regulation

  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,

  6 months Follow-up

• Levels of child behavioral difficulties

  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.

  Pre-intervention (one week before the intervention)

• Changes in child behavioral difficulties

  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.

  Post-intervention (one week after the intervention)

• Fluctuations in child behavioral difficulties

  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.

  6 months follow-up

Secondary Outcomes (3)

• Level of emotional distress

  baseline, pre-intervention

• Changes in emotional distress

  Post-intervention (one week after the intervention)

• Fluctuations in emotional distress

  6 months follow-up

Study Arms (3)

REThink game

EXPERIMENTAL

Each recruited participant randomized in the experimental group will receive the REThink game app.

Other: REThink Game

MoodWheel

ACTIVE COMPARATOR

The participants randomized in the control group will complete the MoodWheel app.

Other: MoodWheel

PsyPills

EXPERIMENTAL

Participants from experimental group who do not respond to REThink game alone will receive the PsyPills app

Other: REThink Game; Other: PsyPills

Interventions

REThink Game OTHER

REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.

PsyPills; REThink game

MoodWheel OTHER

Mood Wheel is a web and mobile-based app that uses experience sampling procedures for the assessment of current/previous distress and positive emotions. The aim of the app is to inquire about the valence, control and functionality of users' emotions.

MoodWheel

PsyPills OTHER

PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments. Psychological Pills (PsyPills) are inspired by Rational-Emotive \& Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions. The PsyPills app was tested in a pilot study and showed positive effects on reducing distress.

PsyPills

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children and adolescents between 8 and 16 years old
• provided written parental consent
• able to access mobile/internet applications on their device

You may not qualify if:

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

Sponsors & Collaborators

• Babes-Bolyai University: lead
• The Executive Agency for Higher Education, Research, Development and Innovation Funding: collaborator

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ph.D of Clinical Psychology

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 17, 2023
• Study Start: October 7, 2023
• Primary Completion: November 10, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)