Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06954051
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERFs Game-based Assessment in AYAs: Validation of Game-based Assessment of Emotion Regulation Abilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotion regulation', 'timeFrame': 'Baseline', 'description': 'The Cognitive Emotion Regulation Questionnaire (CERQ-short) is an 18-item scale assessing nine different emotion regulation strategies, namely Self-blame, Other-blame, Rumination, Catastrophizing, Positive refocusing, Planning, Positive reappraisal, Putting into perspective and Acceptance. Children and adolescents were asked to express the frequency of using each strategy on a 5-point Likert-type scale, from 1 ("almost never") to 5 ("almost always"). Higher scores on adaptive strategies (e.g., positive reappraisal, refocus on planning, positive refocusing, putting into perspective, acceptance) are equivalent to a better outcome (more adaptive coping). Higher scores on maladaptive strategies (e.g., rumination, catastrophizing, self-blame, other-blame) are equivalent to worse outcomes (less adaptive coping).'}, {'measure': 'Behavioral difficulties', 'timeFrame': 'Baseline', 'description': 'The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for children aged 2 to 17 years old, encompassing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.\n\nTotal difficulties score: Sum of all subscales except Prosocial → Range: 0 to 40. Prosocial score is reported separately → Range: 0 to 10. Higher scores on total difficulties and the four problem subscales are equivalent to worse outcomes. Higher scores on the prosocial subscale are equivalent to better outcomes.'}, {'measure': 'Stress', 'timeFrame': 'Baseline', 'description': "The Adolescent Stress Scale (ADOSS) will be used to capture students' level of stress in the following domains: personal, academic, family, and social. Total score ranges from 20 to 100, with higher scores indicating higher levels of stress."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emotion Regulation']}, 'descriptionModule': {'briefSummary': 'This activity will have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults.', 'detailedDescription': "Each level of the REThink LIFE online game dedicated to training a specific ER skill has an assessment task for emotion recognition, stress reactivity, mindfulness and positive attention abilities. The aim of this study will be to investigate the validity of in-game performance measurements or scores as indicators of adolescents and young adults' emotion regulation abilities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable\n\nExclusion Criteria:\n\n* intellectual disability or physical limitations precluded the use of the computer program'}, 'identificationModule': {'nctId': 'NCT06954051', 'briefTitle': 'ERFs Game-based Assessment in AYAs: Validation of Game-based Assessment of Emotion Regulation Abilities', 'organization': {'class': 'OTHER', 'fullName': 'Babes-Bolyai University'}, 'officialTitle': 'Validation of Game-based Assessment of Emotion Regulation Abilities Using the REThink Life Online Game in a Population of Adolescents and Young Adults', 'orgStudyIdInfo': {'id': 'REThinkRESILIENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'REThink Life', 'description': 'The participants will complete the scale measurements after receiving the four levels of the REThink Life game, each focusing on an emotion regulation skill and an associated assessment system.', 'interventionNames': ['Other: REThink Life']}], 'interventions': [{'name': 'REThink Life', 'type': 'OTHER', 'description': 'REThink Life is a therapeutic game developed by David and collaborators (2019) and it is composed of four levels, each training a different emotion regulation ability (emotion recognition, mindfulness, distinguishing between rational and irrational thoughts, and positive attention bias).', 'armGroupLabels': ['REThink Life']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400015', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Babes-Bolyai University', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'overallOfficials': [{'name': 'Oana A. David, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Babes-Bolyai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Babes-Bolyai University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Executive Agency for Higher Education, Research, Development and Innovation Funding', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor PhD', 'investigatorFullName': 'Oana David', 'investigatorAffiliation': 'Babes-Bolyai University'}}}}