Oana David
Cluj-Napoca, 400015, Romania
NCT Number: NCT04949620
The general objective of the study is to test an online platform for the promotion of emotional health in children
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Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Cluj-Napoca, 400015, Romania
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles
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 The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.
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 The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.
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"
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.
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"
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"
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"
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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").
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").
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").
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").
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".
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.
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.
Babes-Bolyai University
Other
REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health
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