- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05424601
Intervention in a Small-scale Study of Game Based Cognitive Change Skills
6. september 2022 opdateret af: Oana David, Babes-Bolyai University
Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching With or Without EMI
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Preliminary efficacy will be tested in an emotion-regulation framework.
Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition.
Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation.
Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
78
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Cluj
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Cluj-Napoca, Cluj, Rumænien
- Babeș-Bolyai University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 16 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- children and adolescents between 10 and 16 years old
- provided written parental consent
- able to access mobile/internet applications on their device
Exclusion Criteria:
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Styring
Kontrolgruppe
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Eksperimentel: Rethink game plus PsyPills
Rethink game followed by PsyPills
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REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
PsyPills is a mobile app designed to provide personalized psychological pills
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Eksperimentel: Rethink Game
Rethink game only
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REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Levels of rational and irrational beliefs
Tidsramme: Baseline
|
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")
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Baseline
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Changes in levels of rational and irrational beliefs
Tidsramme: Post-intervention (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")
|
Post-intervention (one week after the intervention)
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Levels of emotion-regulation
Tidsramme: Baseline
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The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001).
It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,
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Baseline
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Changes in levels of emotion-regulation
Tidsramme: Post-intervention (one week after the intervention)
|
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001).
It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,
|
Post-intervention (one week after the intervention)
|
Level of distress
Tidsramme: Post-intervention (one week after the intervention)
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Measured with Profile of Emotional Distress
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Post-intervention (one week after the intervention)
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Emotion regulation abilities
Tidsramme: Baseline
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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.
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Baseline
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Changes in emotion regulation abilities
Tidsramme: Post-intervention (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.
|
Post-intervention (one week after the intervention)
|
Reflective functioning
Tidsramme: Baseline
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The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.
|
Baseline
|
Changes in reflective functioning
Tidsramme: Post-intervention (one week after the intervention)
|
The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.
|
Post-intervention (one week after the intervention)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. juni 2022
Primær færdiggørelse (Faktiske)
5. september 2022
Studieafslutning (Faktiske)
7. september 2022
Datoer for studieregistrering
Først indsendt
15. juni 2022
Først indsendt, der opfyldte QC-kriterier
16. juni 2022
Først opslået (Faktiske)
21. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RETthinkEMOTIONS3
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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