Not Yet RecruitingNot Applicable

A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)

Spain465 participantsStarted 2026-04-01

Plain-language summary

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. Participants will be randomly assigned to one of three groups: AGENCIA 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. Digital psychoeducation (control): a self-guided online program providing general information about adolescent well-being. The main research questions are: Does 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? Participants will: * Complete three structured sessions depending on their assigned group. * Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups. * Receive brief phone calls during follow-ups to support questionnaire completion. A 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.

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SDQ Total Difficulties Score

Timeframe: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)

Trial details

NCT IDNCT07560072

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Clara Rosso Fernandez

+34 955 013414 claram.rosso.sspa@juntadeandalucia.es

View on ClinicalTrials.gov More Irritability trials