An Integrative Platform for Promoting Children's Emotional Health

NCT ID: NCT04949620

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2022-08-31

Brief Summary

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The general objective of the study is to test an online platform for the promotion of emotional health in children

Detailed Description

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The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.

The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.

Conditions

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Emotional Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The first stage investigates the efficacy of the online REThink therapeutic game in comparison with monitoring in the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the intervention, the online parenting intervention will be implemented, while the other groups will be monitored for other 4 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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REThink game, then responder monitoring

Participants in this group will have access to the REThink game for four weeks; based on their response to the intervention, they will be monitored for an additional period of four weeks.

Group Type EXPERIMENTAL

REThink therapeutic game

Intervention Type BEHAVIORAL

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, then online parent intervention for non-responders

Participants who are allocated to the REThink game and do not respond to the four-week intervention will be allocated to the online

Group Type EXPERIMENTAL

REThink therapeutic game

Intervention Type BEHAVIORAL

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.

Online parenting program

Intervention Type BEHAVIORAL

The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles

Monitoring

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REThink therapeutic game

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.

Intervention Type BEHAVIORAL

Online parenting program

The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children aged 8 to 12 years
* scores above average at any subscale of Childhood Trauma Questionnaire
* parental consent provided
* for the parental intervention: no changes in children's main outcomes following the REThink intervention

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Executive Agency for Higher Education, Research, Development and Innovation Funding

OTHER

Sponsor Role collaborator

Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Oana David

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oana David

Cluj-Napoca, , Romania

Site Status

Countries

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Romania

Other Identifiers

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2576/ 18.03.2021

Identifier Type: -

Identifier Source: org_study_id

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