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Completed

NCT Number: NCT04949620

An Integrative Platform for Promoting Children's Emotional Health

The general objective of the study is to test an online platform for the promotion of emotional health in children

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Key information

Conditions

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oana David

Cluj-Napoca, 400015, Romania

About this study

The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.

The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.

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
  • scores above average at any subscale of Childhood Trauma Questionnaire
  • parental consent provided
  • for the parental intervention: no changes in children's main outcomes following the REThink intervention

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 therapeutic 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.

Online Parenting Program

Behavioral

The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles

Primary outcomes

  1. Children's emotional symptoms

    Time frame: baseline

    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

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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.

Secondary outcomes

  1. Child irrationality

    Time frame: baseline

    The Child and Adolescent Scale of Irrationality "Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132"

  2. Child trauma

    Time frame: baseline

    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.

  3. Child behavioral difficulties

    Time frame: baseline

    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. Changes in child irrationality

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    The Child and Adolescent Scale of Irrationality "Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132"

  5. Changes in child behavioral difficulties

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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"

  6. Changes in children emotional abilities

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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.

Other outcomes

  1. Parenting practices

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).

  2. Changes in parenting practices

    Time frame: post second-stage intervention (8 weeks following baseline)

    The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).

  3. Changes in parenting practices - follow up

    Time frame: 6-month follow-up

    The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).

  4. Changes in parenting practices - follow up one year

    Time frame: 12-month follow-up

    The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).

  5. Parent distress

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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).

  6. Changes in parent distress

    Time frame: post second-stage intervention (8 weeks following baseline)

    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).

  7. Changes in parent distress -follow up

    Time frame: 6-month follow-up

    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).

  8. Changes in parent distress -follow up one year

    Time frame: 12-month follow-up

    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).

  9. Parent beliefs

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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).

  10. Changes in parent beliefs

    Time frame: post second-stage intervention (8 weeks following baseline)

    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).

  11. Changes in parent beliefs - follow up

    Time frame: 6-month follow-up

    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).

  12. Changes in parent beliefs - follow up one year

    Time frame: 12-month follow-up

    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).

  13. Parent emotion regulation

    Time frame: immediately post first-stage intervention (4 weeks following baseline)

    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").

  14. Changes in parent emotion regulation

    Time frame: post second-stage intervention (8 weeks following baseline)

    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").

  15. Changes in parent emotion regulation - follow up

    Time frame: 6-month follow-up

    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").

  16. Changes in parent emotion regulation - follow up one year

    Time frame: 12-month follow-up

    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").

  17. Child attachment (moderator variable)

    Time frame: baseline

    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".

  18. Academic burnout

    Time frame: Baseline

    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.

  19. Changes in academic burnout

    Time frame: post second-stage intervention (8 weeks following baseline)

    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.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

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

Registry information

Official study title

REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2021
Registry last updated
Mar 6, 2024

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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