Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT05154292
Status:
UNKNOWN
Last Update Posted:
2021-12-13
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAEM: A Serious Game for Emotional Regulation Problems in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Difficulties in Emotional Regulation Scale (DERS; Hervás & Jódar, 2008)', 'timeFrame': 'Change from baseline at immediately after the intervention, and at 3 months', 'description': 'Consists of 28 items that make up 6 dimensions of emotional dysregulation: attention, acceptance, impulsivity, clarity, goals and strategies. The reliability index is between .87 and .93.'}, {'measure': 'Revised Child Anxiety and Depression Scale (RCADS-30; Pineda et al., 2018)', 'timeFrame': 'Change from baseline at immediately after the intervention, and at 3 months', 'description': 'it is a 30-item scale to assess the presence of symptoms associated or compatible with depression and anxiety in children and adolescents. Internal consistency between .78 and .93.'}], 'secondaryOutcomes': [{'measure': 'Avoidance and Fusion Questionnaire for Young People (AFQ-Y; Valdivia-Salas, Martín-Albo, Zaldívar, Lombas, & Jiménez, 2016)', 'timeFrame': 'Change from baseline at immediately after the intervention, and at 3 months', 'description': "that assesses the level of avoidance and cognitive fusion present when faced with distressing situations. This scale presents a Cronbach's alpha between .76 and 87."}, {'measure': '. Willingness and Action Scale for Children and Adolescents (WAM; Cobos, Flujas-Contreras, & Gomez, 2020)', 'timeFrame': 'Change from baseline at immediately after the intervention, and at 3 months', 'description': ') to assess levels of acceptance and behavioral activation (action) in the direction of valued life areas. This scale shows an internal consistency between .76 and .81.'}, {'measure': 'Mood and coping', 'timeFrame': 'Change from baseline at immediately after the intervention, and at 3 months', 'description': 'At the start and close of the App, a series of questions will appear that measure mood of the users by means of a visual face scale (5-point Likert) and a coping question by means of a 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotion Regulation', 'Adolescents', 'Serious Game', 'Anxiety', 'Behavior problems'], 'conditions': ['Adolescents']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effects of an intervention to improve emotional regulation skills in adolescents with affective (anxiety and/or depression) and behavioral problems.', 'detailedDescription': 'Emotional regulation skills and strategies are a protective factor against various problems and psychopathologies. The development and maintenance of affective symptoms are usually very harmful to the adolescent and for his/her family and social environment and can lead to other more serious psychological problems (depression, anxiety, adaptive disorders, etc.) or problems of socio-educational maladjustment.\n\nThis study aims to improve the emotional regulation of adolescents who present affective symptoms related to anxiety, depression, or behavioral problems, such as difficulties in their interpersonal relationships, impulsivity, anxiety, anger attacks, low tolerance to frustration, apathy, or sadness. The intervention program, applied through a video game, is an intervention protocol for emotional well-being that has been tested and validated in an adolescent population with emotional and behavioral problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 12 and 16 years old\n* Show affective symptoms associated with depression and anxiety or behavior problems\n* Show willingness to participate in the research study\n* Understand written and spoken Spanish\n* Show stability in treatment dosage, if taking medication.\n\nExclusion Criteria:\n\n* Exhibit incapacitating neurological and/or intellectual impairment\n* Have a diagnosis of severe mental disorder\n* Substance abuse addiction or dependence'}, 'identificationModule': {'nctId': 'NCT05154292', 'acronym': 'SAEMGame', 'briefTitle': 'SAEM: A Serious Game for Emotional Regulation Problems in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Almeria'}, 'officialTitle': 'A Serious Game for Psychological Assessment and Intervention in Adolescents With Emotional Regulation Problems', 'orgStudyIdInfo': {'id': 'UALPsy002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eHealth Emotion Regulation Skills', 'description': 'The intervention aims to develop competencies for emotional regulation through exposure and acceptance strategies for coping with circumstances that produce stress or emotional discomfort. The application has a series of mini-games that the user will overcome throughout a narrative, with different challenges and rewards', 'interventionNames': ['Behavioral: Serious Game: Emotional Health Island (SAEM)']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List', 'description': 'He or she will not be exposed to the intervention but will remain on the waiting list and will complete the pre and post-measures.'}], 'interventions': [{'name': 'Serious Game: Emotional Health Island (SAEM)', 'type': 'BEHAVIORAL', 'otherNames': ['Isla de SAEM (Salud Emocional) (ES)'], 'description': 'This intervention aims to aim to develop competencies for emotional regulation through exposure and acceptance strategies. This intervention is applied through a serious game developed for this purpose. the adolescent will complete a series of missions aimed at developing skills related to psychological flexibility, namely, greater psychological acceptance, mindfulness in the present moment, and committed actions in the direction of personal values. This serious game is guided by a therapist.', 'armGroupLabels': ['eHealth Emotion Regulation Skills']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04009', 'city': 'Almería', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Torrecardenas Hospital', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '04120', 'city': 'Almería', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'University of Almería', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '12071', 'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'University Jaume I', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'centralContacts': [{'name': 'Inmaculada Gómez-Becerra, Prof.', 'role': 'CONTACT', 'email': 'igomez@ual.es', 'phone': '+34 950 214414'}, {'name': 'Juan M Flujas-Contreras, PhD', 'role': 'CONTACT', 'email': 'jm.flujas@ual.es'}], 'overallOfficials': [{'name': 'Inmaculada Gómez Becerra, Prof PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Almeria'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'At the end of the RCT. For a period of 1 year.', 'ipdSharing': 'YES', 'description': 'The data will be published in a data repository and in the publications that are necessary. The data related to the responses will be published in the self-reported evaluation systems, mainly, pre, post and follow-up that have an impact on the evaluation of the effectiveness of the treatment.', 'accessCriteria': 'Open access in data repository or under request to authors.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Almeria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Jaume I', 'class': 'OTHER'}, {'name': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Juan Miguel Flujas', 'investigatorAffiliation': 'Universidad de Almeria'}}}}