Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 6:54 AM
Study NCT ID:
NCT06350760
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bullying', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Cyberbullying. peer bullying screening. Scores range from 0 to 40. The higher the score, the greater the role played in bullying (aggressor, victim, observer).'}, {'measure': 'Expressed Emotion', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Expressed Emotion Evaluation Questionnaire. The scores range from 1 to 7. The higher the score, the greater the difficulties in the family communication style.'}, {'measure': 'Ecoanxiety', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Climate Anxiety Scale. Scores range from 13 to 52. The higher the score, the greater the climate anxiety.'}, {'measure': 'Exam anxiety', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Test anxiety questionnaire adapted for ESO and Baccalaureate. Scores range from 35 to 140. The higher the score, the greater the anxiety before the exams.'}, {'measure': 'Videogames addiction', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Game Addiction Scale for Adolescents (GASA). Scores range from 0 to 28. The higher the score, the greater the risk of video game addiction.'}, {'measure': 'Smartphone addiction', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Smartphone Addiction Scale - Short Version (SAS-SV). Scores range from 10 to 70. The higher the score, the greater the risk of smartphone addiction.'}], 'primaryOutcomes': [{'measure': 'Self-reported anxiety and mood symptomatology', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': "The study's primary outcome was self-reported anxiety and mood symptomatology as assessed by Revised Child Anxiety Depression Scale (RCADS-30). Total scores range from 0 to 90. Higher scores mean a worse outcome"}, {'measure': "Factors associated with adolescents' mental health", 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': "The study's primary outcome was self-reported risk and protective factors level of emotional disorders as assessed by Strengths and Difficulties Questionnaire (SDQ). Total scores range from 0 to 50. Higher scores mean a worse outcome."}, {'measure': 'Resilience measure', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'This primary measure was intended to measure the resilience of adolescents through 10 items with 5 response options. Scores range from 0 to 40. The higher the score, the greater the resilience.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Secondary outcome assessed included self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. Total scores range from 10 to 50. Higher scores mean a better outcome.'}, {'measure': 'Absence of emotional disorders', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': "The study's primary outcome was absence of any emotional disorders over the long-term measured by the ADIS-5-C/P"}], 'secondaryOutcomes': [{'measure': 'Economic evaluations', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Implementation service costs (training, program materials, provider salaries), costs to school system, and later health costs saved for preventing emotional problems that could narrow cumulative disparities in mental health and disadvantage later in life.'}, {'measure': 'Psychological flexibility', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'Psychological flexibility as assessed by Willingness and Action Measure for Children and Adolescents (WAM-C/A).\n\nTotal scores range from 0 to 56. Higher scores mean a better outcome.'}, {'measure': 'Emotional regulation', 'timeFrame': 'Baseline to 7 months after start of interventions', 'description': 'The Difficulties in Emotion Regulation Scale (DERS). Scores range from 0 to 150. The higher the score, the greater the difficulties in emotional regulation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transdiagnostic', 'emotional disorders', 'anxiety', 'depression', 'adolescents', 'child and youth population', 'indicated prevention'], 'conditions': ['Anxiety Disorders and Symptoms', 'Depressive Symptoms']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ehrenreich-May, J.; & Kennedy, S.M. (2022). Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales en niños y adolescentes: Manual del terapeuta. Ediciones Pirámide.'}, {'pmid': '36635735', 'type': 'BACKGROUND', 'citation': 'Vivas-Fernandez M, Garcia-Lopez LJ, Piqueras JA, Muela-Martinez JA, Canals-Sans J, Espinosa-Fernandez L, Jimenez-Vazquez D, Diaz-Castela MDM, Morales-Hidalgo P, Rivera M, Ehrenreich-May J. Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders. Child Adolesc Psychiatry Ment Health. 2023 Jan 12;17(1):7. doi: 10.1186/s13034-022-00550-2.'}]}, 'descriptionModule': {'briefSummary': "PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty.", 'detailedDescription': 'The general objetive of PROCARE-I+ is to implement and evaluate an indicated 8-session preventive group intervention with add-on modules for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The intervention will be based on the Unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A), already proven as effective in the US, but adapted with indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program.\n\nMETHODOLOGY: In order to achieve this objetive, PROCARE-I+ working plan will be divided into 3 steps. Firstly, in order to identify adolescents at high risk of suffering emotional disorders (anxiety and depression), the following self-reports will be administered to adolescents: Strengths and Difficulties Questionnaire (SDQ) to evaluate adolescents at-risk of emotional disorders, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Then, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. Valuing voices from stakeholders and end-users, the investigators will focus on the study of the influence of the above described variables. Third, the investigators will test PROCARE-I with add-on modules.\n\nIMPACT: The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent from adolescent and legal guardian\n* able to attend prevention modules on his/her own\n* language competence\n* Strengths and Difficulties Questionnaire ""probable diagnoses"\n* score above cut-off for Revised Child Anxiety and Depression Scale-30\n* having incipient symptoms on an emotional level in ADIS 5 C/P\n* absence of anxiety and/or mood disorders\n\nExclusion Criteria:\n\n* in- or outpatient\n* concomitant psychological/psychiatric treatment\n* acute suicidality\n* general medical contraindications that hamper attendance to prevention modules\n* have been diagnosed with a neurodevelopmental disorder\n* Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"\n* presence of mood and/or anxiety disorders'}, 'identificationModule': {'nctId': 'NCT06350760', 'acronym': 'PROCARE-I+', 'briefTitle': 'Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules', 'organization': {'class': 'OTHER', 'fullName': 'University of Jaén'}, 'officialTitle': 'Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)', 'orgStudyIdInfo': {'id': 'UJA_PROCARE-I+'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROCARE-I (UP-A for indicated purposes)', 'description': 'To ensure cost-effectiveness, PROCARE-I intervention will be designed as a brief 8-session child-focused programme by adapting the core modules from UP-A, along with one individual session with adolescent and parents. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness.', 'interventionNames': ['Behavioral: Active control condition']}, {'type': 'EXPERIMENTAL', 'label': 'PROCARE-I+ 8-session (for indicated purposes)', 'description': 'PROCARE-I+ intervention will be designed as a brief 8-session with 4 additonal sessions (add-on modules) child-focused programme by adapting the core modules from UP-A. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness.', 'interventionNames': ['Behavioral: PROCARE-I+ 8-session']}], 'interventions': [{'name': 'Active control condition', 'type': 'BEHAVIORAL', 'description': 'The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.', 'armGroupLabels': ['PROCARE-I (UP-A for indicated purposes)']}, {'name': 'PROCARE-I+ 8-session', 'type': 'BEHAVIORAL', 'description': 'The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021. In addition, PROCARE-I+ adds additional modules, which allow adolescents to be provided with tools to address the risk factors they present.', 'armGroupLabels': ['PROCARE-I+ 8-session (for indicated purposes)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Antonio Piqueras, Ph. D.', 'role': 'CONTACT', 'email': 'jpiqueras@umh.es', 'phone': '966658343'}, {'name': 'José Antonio Piqueras, Ph. D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidad Miguel Hernández', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '23071', 'city': 'Jaén', 'state': 'Jaen', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Joaquín García-López, Ph. D.', 'role': 'CONTACT', 'email': 'ljgarcia@ujaen.es', 'phone': '953213412'}, {'name': 'Luis Joaquín García-López, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José Antonio Muela-Martínez, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lourdes Espinosa-Fernández, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura Zafra-Palomino, Ph. D. stud', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Jiménez-Vázquez, Ph. D. stud', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '43003', 'city': 'Tarragona', 'state': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josefa Canals, M.D.', 'role': 'CONTACT', 'email': 'josefa.canals@urv.cat', 'phone': '977257895'}, {'name': 'Josefa Canals, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitat Rovira i Virgili', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'centralContacts': [{'name': 'LuisJoaquín J García-López, Ph.D.', 'role': 'CONTACT', 'email': 'ljgarcia@ujaen.es', 'phone': '953213412'}, {'name': 'Laura Zafra-Palomino, Ph.D.stud', 'role': 'CONTACT', 'email': 'lzpalomi@ujaen.es', 'phone': '953213412'}], 'overallOfficials': [{'name': 'Luis Joaquín García-López, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jaén'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'From June 2024', 'ipdSharing': 'YES', 'description': 'Authors of secondary analyses using shared data will attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They will also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses will explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data will deserve substantial credit for their efforts. Those using data collected by others will seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data will be recognized.', 'accessCriteria': 'upon request to authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jaén', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, {'name': 'University of Miami', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'LuisJoaquin Garcia-Lopez', 'investigatorAffiliation': 'University of Jaén'}}}}