NCT05424900

Brief Summary

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

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

May 3, 2021

Completed
1.1 years 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 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

June 15, 2022

Last Update Submit

October 3, 2023

Conditions

Emotional Problem

Keywords

online therapeutic gameemotional problemsprevention

Outcome Measures

Primary Outcomes (6)

  • Child emotion regulation

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilitie

    baseline; pre-intervention (one week before the intervention)

  • Changes in child emotion regulation

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities.

    post-test, one week after the intervention

  • Children emotional regulation

    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; pre-intervention (one week before the intervention)

  • Changes in children emotional regulation

    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-test, one week after the intervention

  • child emotional simptoms

    SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998)

    baseline; pre-intervention (one week before the intervention)

  • Changes in child emotional simptoms

    SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)

    post-test, one week after the intervention

Secondary Outcomes (5)

  • Children's irrational beliefs

    baseline; pre-intervention (one week before the intervention)

  • changes in Children's irrational beliefs

    post-test, one week after the intervention

  • child behavioral difficulties

    baseline; pre-intervention (one week before the intervention)

  • Mental health

    baseline; pre-intervention (one week before the intervention)

  • Changes child mental health

    post-test, one week after the intervention

Other Outcomes (2)

  • Child trauma

    baseline; pre-intervention (one week before the intervention)

  • Child attachment

    baseline; pre-intervention (one week before the intervention)

Study Arms (2)

REThink game

EXPERIMENTAL

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.

Behavioral: Rethink game

Monitoring

NO INTERVENTION

Participants in this arm will be monitored for a total of eight weeks, for comparison with the REThink game intervention (after four weeks).

Interventions

Rethink gameBEHAVIORAL

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.

REThink game

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged 8 to 12 years
  • parental consent provided
  • al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein \& Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse

You may not qualify if:

  • intellectual disability or physical limitations precluding the use of the online platform presence of a mental health disorder in the children or their enrolled parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

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
SPONSOR INVESTIGATOR
PI Title
Professor Ph.D

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

May 3, 2021

Primary Completion

September 15, 2022

Study Completion

September 30, 2022

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)