Clinical trial NCT05424900: An Integrative Intervention for Preventing Children's Emotional Disorders
Official title: An Integrative Intervention for Preventing Children's Emotional Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Keywords: online therapeutic game
emotional problems
prevention
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2022-06-21
Enrollment: 294
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 \&amp; 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

Primary outcomes:
measure: Child emotion regulation
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Changes in child emotion regulation
timeFrame: post-test, one week after the intervention
measure: Children emotional regulation
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Changes in children emotional regulation
timeFrame: post-test, one week after the intervention
measure: child emotional simptoms
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Changes in child emotional simptoms
timeFrame: post-test, one week after the intervention
Secondary outcomes:
measure: Children's irrational beliefs
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: changes in Children's irrational beliefs
timeFrame: post-test, one week after the intervention
measure: child behavioral difficulties
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Mental health
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Changes child mental health
timeFrame: post-test, one week after the intervention
Other outcomes:
measure: Child trauma
timeFrame: baseline; pre-intervention (one week before the intervention)
measure: Child attachment
timeFrame: baseline; pre-intervention (one week before the intervention)
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References: