An Integrative Intervention for Preventing Children's Emotional Disorders

Sponsor
Oana David (Other)
Overall Status
Recruiting
CT.gov ID
NCT05424900
Collaborator
The Executive Agency for Higher Education, Research, Development and Innovation Funding (Other)
250
1
2
16.9
14.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Rethink game
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
An Integrative Intervention for Preventing Children's Emotional Disorders
Actual Study Start Date :
May 3, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Children's emotional symptoms [baseline; pre-intervention (one week before the intervention)]

    The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach & Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

  2. Changes in children's emotional symptoms - immediately [post-test, one week after the intervention]

    The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach & Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

  3. Child emotion regulation [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

  4. Changes in child emotion regulation [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.

  5. Children emotional regulation [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.

  6. Changes in children emotional regulation [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.

Secondary Outcome Measures

  1. Children's irrational beliefs [baseline; pre-intervention (one week before the intervention)]

    The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement").

  2. changes in Children's irrational beliefs [post-test, one week after the intervention]

    The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement").

  3. Parent distress [baseline; pre-intervention (one week before the intervention)]

    The Profile of Emotional Distress (PED; Opris & Macavei, 2005) is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).

  4. Changes in parent distress [post-test, one week after the intervention]

    The Profile of Emotional Distress (PED; Opris & Macavei, 2005) is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from "Not at all" (0) to "Extremely" (4).

  5. Parent beliefs [baseline; pre-intervention (one week before the intervention)]

    The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).

  6. Changes parent beliefs [post-test, one week after the intervention]

    The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).

  7. Parent emotion regulation [baseline; pre-intervention (one week before the intervention)]

    The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").

  8. Changes in parent emotion regulation [post-test, one week after the intervention]

    The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").

  9. Child attachment [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".

  10. Chanegs in child attachment [post-test, one week after 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".

  11. Academic burnout [baseline; pre-intervention (one week before the intervention)]

    The School Burnout Inventory (Salmela-Aro et al., 2009) consists of 9 items that measure three aspects of school burnout, namely, exhaustion at school, cynicism toward the meaning of school, and the sense of inadequacy at school.

  12. Academic burnout [post-test, one week after the intervention]

    The School Burnout Inventory (Salmela-Aro et al., 2009) consists of 9 items that measure three aspects of school burnout, namely, exhaustion at school, cynicism toward the meaning of school, and the sense of inadequacy at school.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • children aged 8 to 12 years

  • parental consent provided

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Babes-Bolyai University Cluj-Napoca Romania

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oana David, Professor Ph.D, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT05424900
Other Study ID Numbers:
  • REThink Preventive
First Posted:
Jun 21, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oana David, Professor Ph.D, Babes-Bolyai University

Study Results

No Results Posted as of Aug 3, 2022