Clinical trial NCT04949620: An Integrative Platform for Promoting Children's Emotional Health
Official title: REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Keywords: emotional problems
children
parenting
online therapeutic game
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2021-07-02
Enrollment: 256
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: PREVENTION

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.

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

Primary outcomes:
measure: Children's emotional symptoms
timeFrame: baseline
measure: Changes in children's emotional symptoms - immediately
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
Secondary outcomes:
measure: Child irrationality
timeFrame: baseline
measure: Child trauma
timeFrame: baseline
measure: Child behavioral difficulties
timeFrame: baseline
measure: Changes in child irrationality
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in child behavioral difficulties
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in children emotional abilities
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
Other outcomes:
measure: Parenting practices
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in parenting practices
timeFrame: post second-stage intervention (8 weeks following baseline)
measure: Changes in parenting practices - follow up
timeFrame: 6-month follow-up
measure: Changes in parenting practices - follow up one year
timeFrame: 12-month follow-up
measure: Parent distress
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in parent distress
timeFrame: post second-stage intervention (8 weeks following baseline)
measure: Changes in parent distress -follow up
timeFrame: 6-month follow-up
measure: Changes in parent distress -follow up one year
timeFrame: 12-month follow-up
measure: Parent beliefs
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in parent beliefs
timeFrame: post second-stage intervention (8 weeks following baseline)
measure: Changes in parent beliefs - follow up
timeFrame: 6-month follow-up
measure: Changes in parent beliefs - follow up one year
timeFrame: 12-month follow-up
measure: Parent emotion regulation
timeFrame: immediately post first-stage intervention (4 weeks following baseline)
measure: Changes in parent emotion regulation
timeFrame: post second-stage intervention (8 weeks following baseline)
measure: Changes in parent emotion regulation - follow up
timeFrame: 6-month follow-up
measure: Changes in parent emotion regulation - follow up one year
timeFrame: 12-month follow-up
measure: Child attachment (moderator variable)
timeFrame: baseline
measure: Academic burnout
timeFrame: Baseline
measure: Changes in academic burnout
timeFrame: post second-stage intervention (8 weeks following baseline)
Locations:
city: Cluj-Napoca
country: Romania
facility: Oana David
Study officials:
References: