NCT05424601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

June 15, 2022

Last Update Submit

December 2, 2024

Conditions

Keywords

online therapeutic gameemotional problemsemotional regulationchildren and adolescents

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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)

  • 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

  • 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)

Study Arms (3)

Rethink game plus PsyPills

EXPERIMENTAL

Rethink game followed by PsyPills

Behavioral: Rethink gameBehavioral: PsyPills

Rethink Game

EXPERIMENTAL

Rethink game only

Behavioral: Rethink game

Control

NO INTERVENTION

Control group

Interventions

Rethink gameBEHAVIORAL

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.

Rethink GameRethink game plus PsyPills
PsyPillsBEHAVIORAL

PsyPills is a mobile app designed to provide personalized psychological pills

Rethink game plus PsyPills

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children and adolescents between 10 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

June 10, 2022

Primary Completion

September 5, 2022

Study Completion

September 7, 2022

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations