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

NCT07560072 | Not Yet Recruiting

• 1 other identifier: AGENCIA TEENS
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritability; Neurodevelopmental Disorders; Impulsivity; Emotional Dysregulation; Distress, Emotional; Distress, Psychological

Keywords

Adolescents; Randomized controlled trial; Personal Agency; Digital health intervention; Neurodevelopmental disorders; Family accommodation; Conversational AI; Trans diagnostic interventions

Outcome Measures

Primary Outcomes (1)

• SDQ Total Difficulties Score

  Change in emotional and behavioral difficulties measured with the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score. The scale includes 20 items assessing emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems. The total score ranges from 0 to 40, with higher scores indicating greater difficulties. * 0-13: Close to average * 14-16: Slightly raised * 17-19: High * 20-40: Very high The primary comparison is change from baseline day 0 to the 1-month follow-up.

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

Secondary Outcomes (10)

• SDQ Subscale Scores (Emotional, Conduct, Hyperactivity/Inattention, Peer, Prosocial)

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

• SDQ-Impact Score (Functional Impairment)

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

• Aberrant Behavior Checklist (ABC) Subscales

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

• HoNOSCA-SR Total Score

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

• EQ-5 Dimension-5 Level Index Score (Quality of Life)

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

Other Outcomes (9)

• K-Brief Intelligence Test (Intellectual Functioning)

  Baseline Day 0 (T0)

• ABAS-II (Adaptive Functioning)

  Baseline Day 0 (T0)

• SRS-2 (Autistic Traits)

  Baseline Day 0 (T0)

Study Arms (3)

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.

Behavioral: AGENCIA In-person With Digital Assistant

AGENCIA Digital Self-Guided

EXPERIMENTAL

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.

Behavioral: AGENCIA Digital Self-Guided

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.

Interventions

AGENCIA Digital Self-Guided 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.

AGENCIA Digital Self-Guided

AGENCIA In-person With Digital Assistant BEHAVIORAL

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.

AGENCIA In-person with Digital Assistant

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen del Rocio: collaborator
• Instituto de Salud Carlos III: collaborator
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Impulsive Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Nathalia Garrido Torres

  Andalusian Health Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Rosso Fernandez

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are masked in the digital arms due to identical platform design. Outcomes assessors and analysts are masked through self-administered digital assessments and anonymized datasets. The care provider is not masked in the in-person arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm parallel randomized controlled trial with equal allocation (1:1:1).

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documents will be available after publication of the main study results. Data may be requested for up to 5 years after publication. Availability beyond this period will depend on institutional policies and ethical approvals.
• Access Criteria: Access will be granted to qualified researchers for scientific and non-commercial purposes. Requests must include a methodologically sound proposal and will require approval from the Research Ethics Committee. A Data Transfer Agreement (DTA) will be required. Only fully de-identified datasets will be shared, delivered through secure institutional channels.

Locations

ES (1)