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Clinical Trials/NCT04949620
NCT04949620
Completed
Not Applicable

REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health

Babes-Bolyai University1 site in 1 country256 target enrollmentMay 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Problem
Sponsor
Babes-Bolyai University
Enrollment
256
Locations
1
Primary Endpoint
Children's emotional symptoms
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2021
End Date
August 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Babes-Bolyai University
Responsible Party
Principal Investigator
Principal Investigator

Oana David

Professor

Babes-Bolyai University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Children's emotional symptoms

Time Frame: baseline

The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

Changes in children's emotional symptoms - immediately

Time Frame: immediately post first-stage intervention (4 weeks following baseline)

The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

Secondary Outcomes

  • Child irrationality(baseline)
  • Changes in child irrationality(immediately post first-stage intervention (4 weeks following baseline))
  • Child behavioral difficulties(baseline)
  • Child trauma(baseline)
  • Changes in child behavioral difficulties(immediately post first-stage intervention (4 weeks following baseline))
  • Changes in children emotional abilities(immediately post first-stage intervention (4 weeks following baseline))

Study Sites (1)

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