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Clinical Trials/NCT05424900
NCT05424900
Completed
N/A

An Integrative Intervention for Preventing Children's Emotional Disorders

Oana David1 site in 1 country294 target enrollmentMay 3, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotional Problem
Sponsor
Oana David
Enrollment
294
Locations
1
Primary Endpoint
Child emotion regulation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2021
End Date
September 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oana David
Responsible Party
Sponsor Investigator
Principal Investigator

Oana David

Professor Ph.D

Babes-Bolyai University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

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)

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)

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.

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.

Secondary Outcomes

  • child behavioral difficulties(baseline; pre-intervention (one week before the intervention))
  • Changes child mental health(post-test, one week after the intervention)
  • Children's irrational beliefs(baseline; pre-intervention (one week before the intervention))
  • changes in Children's irrational beliefs(post-test, one week after the intervention)
  • Mental health(baseline; pre-intervention (one week before the intervention))

Study Sites (1)

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