An Integrative Platform for Promoting Children's Emotional Health

NCT04949620 | Completed

• 1 other identifier: 2576/ 18.03.2021
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emotional Problem

Keywords

emotional problems; children; parenting; online therapeutic game

Outcome Measures

Primary Outcomes (2)

• Children's emotional symptoms

  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 The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

  baseline

• Changes in children's emotional symptoms - immediately

  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 The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

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

Secondary Outcomes (6)

• Child irrationality

  baseline

• Child trauma

  baseline

• Child behavioral difficulties

  baseline

• Changes in child irrationality

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

• Changes in child behavioral difficulties

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

Other Outcomes (19)

• Parenting practices

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

• Changes in parenting practices

  post second-stage intervention (8 weeks following baseline)

• Changes in parenting practices - follow up

  6-month follow-up

Study Arms (3)

REThink game, then responder monitoring

EXPERIMENTAL

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.

Behavioral: REThink therapeutic game

REThink game, then online parent intervention for non-responders

EXPERIMENTAL

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

Behavioral: REThink therapeutic game; Behavioral: Online parenting program

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) and the online parenting program (after an additional four weeks).

Interventions

REThink therapeutic game 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; REThink game, then responder monitoring

Online parenting program BEHAVIORAL

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

REThink game, then online parent intervention for non-responders

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Babes-Bolyai University: lead
• The Executive Agency for Higher Education, Research, Development and Innovation Funding: collaborator

Study Sites (1)

Oana David

Cluj-Napoca, 400015, Romania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: July 2, 2021
• Study Start: May 3, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 31, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)