An Integrative Intervention for Preventing Children's Emotional Disorders

Emotional Problem Clinical Trial

Official title:

An Integrative Intervention for Preventing Children's Emotional Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424900
• Other study ID #: REThink Preventive
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: September 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotional Problem

Intervention

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.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Oana David	The Executive Agency for Higher Education, Research, Development and Innovation Funding

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child trauma	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)
Other	Child attachment	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)
Primary	Child emotion regulation	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)
Primary	Changes in child emotion regulation	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
Primary	Children emotional regulation	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)
Primary	Changes in children emotional regulation	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
Primary	child emotional simptoms	SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998)	baseline; pre-intervention (one week before the intervention)
Primary	Changes in child emotional simptoms	SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)	post-test, one week after the intervention
Secondary	Children's irrational beliefs	The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)	baseline; pre-intervention (one week before the intervention)
Secondary	changes in Children's irrational beliefs	The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999)	post-test, one week after the intervention
Secondary	child behavioral difficulties	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)
Secondary	Mental health	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)
Secondary	Changes child mental health	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