A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Trial Details
| Condition | Irritability, Neurodevelopmental Disorders, Impulsivity, Emotional Dysregulation, Distress, Emotional, Distress, Psychological |
| Intervention | AGENCIA Digital Self-Guided; AGENCIA In-person With Digital Assistant |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 465 |
| Est. Completion | 31 Mar 2028 |
| Last Updated | 30 Apr 2026 |
Primary Outcome
SDQ Total Difficulties Score
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Adolescents aged 12 to 18 years at enrollment. * Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance). * Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis. * Ability to use digital materials through a personal device and basic reading skills in Spanish. * Availability to attend assessments and participate in the intervention and follow-up schedule. * Informed consent from caregivers and assent from the adolescent. Exclusion Criteria: * 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). * Score of "Severe" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying/social problems). * Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive/expressive language difficulties, motor limitations preventing device use). * Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70. * Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.
Trial Sites
Countries
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