[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636006":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":104,"whyStopped":23,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"AGENCIA In-person with Digital Assistant","EXPERIMENTAL","Participants receive AGENCIA in in-person sessions delivered by a clinician and assisted by a conversational digital tool. The digital assistant guides therapeutic exercises while the clinician supervises delivery. Content is identical to the digital version.",[13],"Behavioral: AGENCIA In-person With Digital Assistant",{"label":15,"type":10,"description":16,"interventionNames":17},"AGENCIA Digital Self-Guided","Participants complete the AGENCIA program in a fully self-guided digital format. The intervention includes three structured online sessions with audiovisual content and experiential exercises, completed independently on a secure platform.",[18],"Behavioral: AGENCIA Digital Self-Guided",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Digital Psychoeducation","NO_INTERVENTION","Participants complete three self-guided online sessions of digital psychoeducation covering adolescent well-being topics (sleep, routines, screen use, physical activity, family communication). No mechanism-based therapeutic strategies are included.",null,[25,29],{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","AGENCIA Digital Self-Guided is a brief, structured psychological intervention designed to strengthen personal agency in adolescents with emotional and behavioral difficulties. The program includes three sessions focused on improving emotion regulation and self-compassion, supporting value-based actions, promoting gradual engagement with meaningful activities, and reducing family accommodation. In the self-guided digital format, participants complete the three sessions independently on a secure online platform with audiovisual materials and experiential exercises.",[15],{"type":26,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"AGENCIA In-person With Digital Assistant","AGENCIA In-person With Digital Assistant is a brief, structured psychological intervention aimed at strengthening personal agency and improving emotional and behavioral functioning in adolescents. It consists of three core sessions addressing emotion regulation, self-compassion, value-based actions, meaningful goal pursuit, and the reduction of family accommodation. In the in-person format, a mental health professional delivers the intervention in person, while a conversational digital assistant guides structured exercises and presents session content. The clinician supervises and ensures safe, consistent delivery. The therapeutic ingredients and objectives of AGENCIA remain identical to those used in the self-guided format.",[9],[34],{"name":35,"affiliation":36,"role":37},"Nathalia Garrido Torres","Andalusian Health Service","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Clara Rosso Fernandez","CONTACT","+34 955 013414","claram.rosso.sspa@juntadeandalucia.es",[45],{"facility":46,"status":23,"city":47,"state":23,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital Universitario Virgen del Rocío","Seville","41013","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-5.97317,37.38283,{"lat":55,"lon":54},[58,61],{"name":35,"role":41,"phone":59,"phoneExt":23,"email":60},"+34 608 30 46 63","nagatorr@gmail.com",{"name":35,"role":37,"phone":23,"phoneExt":23,"email":23},{"type":63,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[65,67],{"name":66,"class":6},"Hospitales Universitarios Virgen del Rocío",{"name":68,"class":69},"Instituto de Salud Carlos III","OTHER_GOV","100636006","a-scalable-trans-diagnostic-intervention-targeting-adolescent-agency-supported-by-conversational-ai-agencia-100636006",false,"NCT07560072","A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)","A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI","AGENCIA","Inclusion Criteria:\n\n* Adolescents aged 12 to 18 years at enrollment.\n* Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).\n* Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.\n* Ability to use digital materials through a personal device and basic reading skills in Spanish.\n* Availability to attend assessments and participate in the intervention and follow-up schedule.\n* Informed consent from caregivers and assent from the adolescent.\n\nExclusion Criteria:\n\n* Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).\n* Score of \"Severe\" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying\u002Fsocial problems).\n* Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive\u002Fexpressive language difficulties, motor limitations preventing device use).\n* Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.\n* Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.","ALL","12 Years","18 Years",{"count":82,"type":83},465,"ESTIMATED","INTERVENTIONAL",[86],"NA","The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.\n\nParticipants will be randomly assigned to one of three groups:\n\nAGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.\n\nDigital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.\n\nThe main research questions are:\n\nDoes AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?\n\nParticipants will:\n\n* Complete three structured sessions depending on their assigned group.\n* Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.\n* Receive brief phone calls during follow-ups to support questionnaire completion.\n\nA total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.",[89,90,91,92,93,94],"Irritability","Neurodevelopmental Disorders","Impulsivity","Emotional Dysregulation","Distress, Emotional","Distress, Psychological",[96,97,98,99,100,101,102,103],"Adolescents","Randomized controlled trial","Personal Agency","Digital health intervention","Neurodevelopmental disorders","Family accommodation","Conversational AI","Trans diagnostic interventions","NOT_YET_RECRUITING","2026-04-23",{"date":107,"type":108},"2026-04-30","ACTUAL",{"date":110,"type":83},"2026-04-01",{"date":112,"type":83},"2028-12-31",{"name":5,"class":6},1]