An Integrative Intervention for Preventing Children's Emotional Disorders

October 3, 2023 updated by: Oana David
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Cluj-Napoca, Romania
        • Babeș-Bolyai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REThink 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.
Behavioral: Rethink 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.
No Intervention: Monitoring
Participants in this arm will be monitored for a total of eight weeks, for comparison with the REThink game intervention (after four weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child emotion regulation
Time Frame: baseline; pre-intervention (one week before the intervention)
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
Time Frame: post-test, one week after the intervention
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
Time Frame: baseline; pre-intervention (one week before the intervention)
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
Time Frame: post-test, one week after the intervention
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
Time Frame: baseline; pre-intervention (one week before the intervention)
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
Time Frame: post-test, one week after the intervention
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)
post-test, one week after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's irrational beliefs
Time Frame: baseline; pre-intervention (one week before the intervention)
The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)
baseline; pre-intervention (one week before the intervention)
changes in Children's irrational beliefs
Time Frame: post-test, one week after the intervention
The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)
post-test, one week after the intervention
child behavioral difficulties
Time Frame: baseline; pre-intervention (one week before the intervention)
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: "a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130"
baseline; pre-intervention (one week before the intervention)
Mental health
Time Frame: baseline; pre-intervention (one week before the intervention)
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: "a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130"
baseline; pre-intervention (one week before the intervention)
Changes child mental health
Time Frame: post-test, one week after the intervention
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: "a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130"
post-test, one week after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child trauma
Time Frame: baseline; pre-intervention (one week before the intervention)
CTQ - Childhood Trauma Questionnaire Bernstein, D. P., Stein, J. A., Newcomb, M. D., Walker, E., Pogge, D., Ahluvalia, T., ... & Zule, W. (2003). Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child abuse & neglect, 27(2), 169-190.
baseline; pre-intervention (one week before the intervention)
Child attachment
Time Frame: baseline; pre-intervention (one week before the intervention)
The Security Scale (Kerns, Klepac, & Cole, 1996) is a 15-item measure of attachment security in children aged 8 to 12. The scale uses a "some kids... other kids..." format and asks respondents to select the degree to which they feel they are similar to the type of children they have previously selected, using a two-point Likert scale ("Really true for me" or "Sort of true for me".
baseline; pre-intervention (one week before the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oana David

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REThink Preventive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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