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AI-Powered therapy for teens shows promise in new trial

NCT ID NCT07560072

Symptom relief Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, to help teens aged 12-18 with emotional and behavioral difficulties like irritability, impulsivity, and conflicts. Participants are randomly assigned to an online self-guided version, an in-person version with a digital assistant, or a control group with general well-being information. The goal is to see if AGENCIA reduces difficulties and improves functioning, with follow-ups up to 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 465 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Impulsive Behavior neurodevelopmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distress, emotional Distress, psychological Emotional dysregulation Impulsivity Irritability Neurodevelopmental disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.