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Completed

NCT Number: NCT05424900

An Integrative Intervention for Preventing Children's Emotional Disorders

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.

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Key information

Conditions

Emotional Problem

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rethink 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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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"

  4. 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"

  5. 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"

Other outcomes

  1. 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.

  2. 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".

Sponsors and collaborators

Lead sponsor

Oana David

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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