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.
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.
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.
Parallel
AGENCIA Digital Self-Guided
BehavioralAGENCIA 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 In-person With Digital Assistant
BehavioralAGENCIA 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.
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.
SDQ Subscale Scores (Emotional, Conduct, Hyperactivity/Inattention, Peer, Prosocial)
Subscale scores of the Strengths and Difficulties Questionnaire (SDQ) capturing specific emotional and behavioral areas. The SDQ consists of 25 items divided into 5 subscales, each containing 5 items rated on a 3-point scale (0 = not true, 1 = somewhat true, 2 = certainly true). Each subscale score ranges from 0 to 10. For the Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Problems subscales, higher scores indicate greater difficulties. For the Prosocial Behavior subscale, higher scores indicate better functioning.
SDQ-Impact Score (Functional Impairment)
Index of functional impairment associated with emotional and behavioral symptoms, including impact on home life, friendships, school learning, and overall distress, measured with the Strengths and Difficulties Questionnaire Impact Supplement. The impact score ranges from 0 to 10, with higher scores indicating greater impairment.
Aberrant Behavior Checklist (ABC) Subscales
Measures irritability, lethargy/withdrawal, stereotypy, hyperactivity/non-compliance, and inappropriate speech using the Aberrant Behavior Checklist. The ABC consists of 58 items across 5 subscales, each scored from 0 (not a problem) to 3 (severe problem). Subscale score ranges are: Irritability (0-45), Lethargy/Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity/Noncompliance (0-48), and Inappropriate Speech (0-12). Higher scores indicate more severe symptoms.
HoNOSCA-SR Total Score
Self-reported global functioning across emotional, behavioral, social, and daily living domains measured with the Health of the Nation Outcome Scales for Children and Adolescents - Self-Rated (HoNOSCA-SR). The scale consists of 13 items, each rated from 0 to 4. The total score ranges from 0 to 52, with higher scores indicating greater impairment.
K-Brief Intelligence Test (Intellectual Functioning)
Intellectual functioning assessed with the Kaufman Brief Intelligence Test, Second Edition, measuring verbal and non-verbal cognitive abilities. The Kaufman Brief Intelligence Test, Second Edition yields an Intelligence Quotient Composite standard score with a normative mean of 100 and standard deviation of 15. Standard scores typically range from 40 to 160, with higher scores indicating better intellectual functioning.
ABAS-II (Adaptive Functioning)
Adaptive functioning assessed with the Adaptive Behavior Assessment System, Second Edition (ABAS-II), providing a General Adaptive Composite (GAC) and conceptual, social, and practical domain scores. The GAC is a standard score with a normative mean of 100 and standard deviation of 15. Standard scores typically range from 40 to 160, with lower scores indicating poorer adaptive functioning.
SRS-2 (Autistic Traits)
Dimensional assessment of autistic traits measured with the Social Responsiveness Scale, Second Edition (SRS-2), used for baseline characterization and heterogeneity analyses. The SRS-2 yields T-scores with a normative mean of 50 and standard deviation of 10. T-scores range from 37 to 90+, with higher scores indicating greater severity of autistic traits. T-scores ≥76 are considered severe, 66-75 moderate, and 60-65 mild.
CBCL (Child Behavior Checklist)
Emotional and behavioral problems assessed with the Child Behavior Checklist (CBCL), providing broadband Internalizing and Externalizing problem scores and syndrome scales. The CBCL yields T-scores with a normative mean of 50 and standard deviation of 10. T-scores range from approximately 30 to 100, with higher scores indicating greater symptom severity. T-scores ≥64 are considered clinically significant.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead sponsor
Hospitales Universitarios Virgen del Rocío
Collaborator
Instituto de Salud Carlos III
Collaborator
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