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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04949620
Other study ID # 2576/ 18.03.2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date August 31, 2022

Study information

Verified date March 2024
Source Babes-Bolyai University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date August 31, 2022
Est. primary completion date August 30, 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
REThink therapeutic 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.
Online parenting program
The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles

Locations

Country Name City State
Romania Oana David Cluj-Napoca

Sponsors (2)

Lead Sponsor Collaborator
Babes-Bolyai University 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 Parenting practices 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). immediately post first-stage intervention (4 weeks following baseline)
Other Changes in parenting practices 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). post second-stage intervention (8 weeks following baseline)
Other Changes in parenting practices - 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). 6-month follow-up
Other Changes in parenting practices - follow up one year 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). 12-month follow-up
Other Parent distress 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). immediately post first-stage intervention (4 weeks following baseline)
Other Changes in parent distress 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). post second-stage intervention (8 weeks following baseline)
Other Changes in parent distress -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). 6-month follow-up
Other Changes in parent distress -follow up one year 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). 12-month follow-up
Other Parent beliefs 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). immediately post first-stage intervention (4 weeks following baseline)
Other Changes in parent beliefs 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). post second-stage intervention (8 weeks following baseline)
Other Changes in parent beliefs - 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). 6-month follow-up
Other Changes in parent beliefs - follow up one year 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-month follow-up
Other Parent emotion regulation 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"). immediately post first-stage intervention (4 weeks following baseline)
Other Changes in parent emotion regulation 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"). post second-stage intervention (8 weeks following baseline)
Other Changes in parent emotion regulation - 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"). 6-month follow-up
Other Changes in parent emotion regulation - follow up one year 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"). 12-month follow-up
Other Child attachment (moderator variable) 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
Other Academic burnout 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. Baseline
Other Changes in academic burnout 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. post second-stage intervention (8 weeks following baseline)
Primary Children's emotional symptoms 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. baseline
Primary Changes in children's emotional symptoms - immediately 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. immediately post first-stage intervention (4 weeks following baseline)
Secondary Child irrationality 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" baseline
Secondary 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
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
Secondary Changes in child irrationality 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" immediately post first-stage intervention (4 weeks following baseline)
Secondary Changes in 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" immediately post first-stage intervention (4 weeks following baseline)
Secondary Changes in children emotional abilities 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. immediately post first-stage intervention (4 weeks following baseline)
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