IrritabilityAGENCIANCT07560072
A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)
A study testing AGENCIA Digital Self-Guided and AGENCIA In-person With Digital Assistant in people with Irritability and Neurodevelopmental Disorders, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Irritability, Neurodevelopmental Disorders, Impulsivity
- What is being tested?
- AGENCIA Digital Self-Guided and AGENCIA In-person With Digital Assistant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Virgen del Rocío
Seville, 41013
Nathalia Garrido Torres, +34 608 30 46 63, nagatorr@gmail.com
Nathalia Garrido Torres
About this study
Official title: A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI
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:
Read more
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.
Read the detailed description
This study is situated at the intersection of mental health, technological innovation, and artificial intelligence, incorporating advanced digital tools and conversational systems as supportive elements for psychological assessment and intervention in clinical settings. Within this framework, the project explores how technology can facilitate the delivery of brief, scalable, and more personalized interventions in child and adolescent mental health.
This study is a three-arm randomized clinical trial designed to evaluate the effectiveness of AGENCIA, a brief, mechanism-focused psychological intervention for adolescents aged 12 to 18 receiving care in routine mental health services. Adolescents in this age range often experience emotional and behavioral difficulties that affect daily functioning at home, school, and in social contexts. These difficulties may include irritability, impulsivity, conflicts with caregivers, or challenges in managing strong emotions, and they may occur with or without a formal neurodevelopmental diagnosis.
AGENCIA is a structured psychological program delivered in three sessions. It aims to strengthen personal agency, improve emotional regulation and self-compassion, support action toward meaningful goals, and help families reduce accommodation behaviors that may limit adolescents' autonomy. The study evaluates two delivery formats: a self-guided digital version and a clinician-delivered in-person version supported by an interactive conversational assistant. A third group receives digital psychoeducation, which provides general information about adolescent well-being without active therapeutic components.
The trial will recruit 465 participants, who will be randomly assigned in a 1:1:1 ratio to one of the study groups. The design is trans diagnostic and dimensional, including adolescents with emotional or behavioral difficulties that interfere with daily functioning, regardless of diagnostic status. Recruitment takes place across child and adolescent mental health services and primary care settings in Spain.
Assessments are conducted at baseline (T0), immediately post-intervention (T1), at 1-month follow-up (T2), and at 6-month follow-up (T3). All assessments are digital and include measures of emotional and behavioral difficulties, functioning, quality of life, family accommodation, and personal agency.
The primary outcome is the change in the Strengths and Difficulties Questionnaire (SDQ-Total Difficulties Score) from baseline to the 1-month follow-up. Secondary outcomes include symptom subscales, emotional dysregulation, functioning, interference in daily life, quality of life, family accommodation, and personal agency. Exploratory analyses will examine whether early changes in personal agency or family accommodation predict later improvement, and whether treatment effects differ across clinical profiles or neurodevelopmental traits.
The study is considered low-risk. It does not involve medication, invasive procedures, or unsupervised generative AI tools. Digital components run on secure institutional servers. Safety monitoring includes routine screening for acute clinical risk at multiple time points, with established referral procedures within the mental health system.
Participation is voluntary, and adolescents continue to receive their usual clinical care during the study. Data are de-identified, securely stored, and may be shared upon reasonable request and ethical approval.
- Conditions
- Irritability, Neurodevelopmental Disorders, Impulsivity, Emotional Dysregulation, Distress, Emotional, Distress, Psychological
- Being tested
- AGENCIA Digital Self-Guided, AGENCIA In-person With Digital Assistant
- Keywords
- Adolescents, Randomized controlled trial, Personal Agency, Digital health intervention, Neurodevelopmental disorders, Family accommodation, Conversational AI, Trans diagnostic interventions
- Medical subject headings
- Neurodevelopmental Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGENCIA Digital Self-GuidedBehavioural
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 In-person With Digital AssistantBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Health-related quality of life index measured with the EuroQol 5-Dimension 5-Level questionnaire, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The index score is calculated using country-specific value sets and ranges from less than 0 (states worse than dead) to 1.0 (perfect health), with higher scores reflecting better health status.
Measured: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
Family Accommodation (FASA / FASA-CR Total Score)
Extent to which caregivers or adolescents engage in accommodation behaviors that may maintain emotional/behavioral difficulties, measured with the Family Accommodation Scale - Anxiety (FASA) for parents and FASA-Child Report (FASA-CR) for adolescents. The FASA total score ranges from 0 to 36, with higher scores indicating more accommodation.
Measured: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Children's Hope Scale - Agency Subscale (CHS-Agency)
Assesses adolescents' sense of personal agency (ability to initiate and sustain goal-directed actions) using the Children's Hope Scale - Agency Subscale. The agency subscale consists of 3 items, each rated from 1 to 6, yielding a subscale score range of 3 to 18, with higher scores indicating stronger perceived agency.
Measured: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Usability, Acceptability, and Satisfaction Questionnaire
Self-reported ratings of satisfaction with the intervention, ease of use, perceived helpfulness, and likelihood of recommending it, measured with an ad hoc Usability and Satisfaction Questionnaire developed for this study. The questionnaire includes 7 closed-ended items assessing perceived benefit, treatment planning, motivation to use strategies, likelihood of recommendation, and modality-specific usability (digital platform, in-person, or conversational AI agent). Each item is rated on a 4-point scale (0 = No, 1 = A little, 2 = Yes, 3 = Very much). Individual item scores range from 0 to 3, with higher scores indicating greater usability, acceptability, and satisfaction. The questionnaire also includes one open-ended item for qualitative feedback.
Measured: Within 1 week post-intervention (T1)
Relational Openness / Self-Disclosure
Relational openness measured with an ad hoc 4-item self-disclosure scale developed for this study, assessing the tendency to talk about oneself, share feelings, express beliefs and opinions, and feel comfortable revealing one's true self during the intervention. Items are adapted to the intervention format (AI conversational agent, therapist-led, or web/app-based). Each item is rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree), with total scores ranging from 4 to 20. Higher scores indicate greater relational openness.
Measured: Within 1 week post-intervention (T1)
Perceived Alliance (Session Rating Scale, SRS)
Working alliance measured with the Session Rating Scale (SRS), a 4-item visual analog scale assessing relationship bond (feeling heard, understood, and respected), agreement on goals and topics, agreement on approach or method, and overall session quality. Each item is rated on a 0-10 visual analog scale, with total scores ranging from 0 to 40. Higher scores indicate stronger perceived therapeutic alliance.
Measured: Within 1 week post-intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrritabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel randomized controlled trial with equal allocation (1:1:1).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Nathalia Garrido Torres, Principal investigator, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560072
- Sponsor's protocol ID
- AGENCIA TEENS
- Acronym
- AGENCIA
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available for sharing. Shared data may include scores from primary and secondary outcomes (SDQ, ABC, HoNOSCA-SR, EQ-5D-5L, FASA, CHS), excluding all direct identifiers. Only fully anonymized datasets will be provided. No information that could allow re-identification will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI
- ClinicalTrials.gov ID
- NCT07560072
- Acronym / sponsor ID
- AGENCIA / AGENCIA TEENS
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Instituto de Salud Carlos III
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is situated at the intersection of mental health, technological innovation, and artificial intelligence, incorporating advanced digital tools and conversational systems as supportive elements for psychological assessment and intervention in clinical settings. Within this framework, the project explores how technology can facilitate the delivery of brief, scalable, and more personalized interventions in child and adolescent mental health.
This study is a three-arm randomized clinical trial designed to evaluate the effectiveness of AGENCIA, a brief, mechanism-focused psychological intervention for adolescents aged 12 to 18 receiving care in routine mental health services. Adolescents in this age range often experience emotional and behavioral difficulties that affect daily functioning at home, school, and in social contexts. These difficulties may include irritability, impulsivity, conflicts with caregivers, or challenges in managing strong emotions, and they may occur with or without a formal neurodevelopmental diagnosis.
AGENCIA is a structured psychological program delivered in three sessions. It aims to strengthen personal agency, improve emotional regulation and self-compassion, support action toward meaningful goals, and help families reduce accommodation behaviors that may limit adolescents' autonomy. The study evaluates two delivery formats: a self-guided digital version and a clinician-delivered in-person version supported by an interactive conversational assistant. A third group receives digital psychoeducation, which provides general information about adolescent well-being without active therapeutic components.
The trial will recruit 465 participants, who will be randomly assigned in a 1:1:1 ratio to one of the study groups. The design is trans diagnostic and dimensional, including adolescents with emotional or behavioral difficulties that interfere with daily functioning, regardless of diagnostic status. Recruitment takes place across child and adolescent mental health services and primary care settings in Spain.
Assessments are conducted at baseline (T0), immediately post-intervention (T1), at 1-month follow-up (T2), and at 6-month follow-up (T3). All assessments are digital and include measures of emotional and behavioral difficulties, functioning, quality of life, family accommodation, and personal agency.
The primary outcome is the change in the Strengths and Difficulties Questionnaire (SDQ-Total Difficulties Score) from baseline to the 1-month follow-up. Secondary outcomes include symptom subscales, emotional dysregulation, functioning, interference in daily life, quality of life, family accommodation, and personal agency. Exploratory analyses will examine whether early changes in personal agency or family accommodation predict later improvement, and whether treatment effects differ across clinical profiles or neurodevelopmental traits.
The study is considered low-risk. It does not involve medication, invasive procedures, or unsupervised generative AI tools. Digital components run on secure institutional servers. Safety monitoring includes routine screening for acute clinical risk at multiple time points, with established referral procedures within the mental health system.
Participation is voluntary, and adolescents continue to receive their usual clinical care during the study. Data are de-identified, securely stored, and may be shared upon reasonable request and ethical approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel randomized controlled trial with equal allocation (1:1:1).
| Arm | Type | Receives |
|---|---|---|
| AGENCIA In-person with Digital Assistant | Experimental | Behavioral: AGENCIA In-person With Digital AssistantParticipants 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. |
| AGENCIA Digital Self-Guided | Experimental | Behavioral: AGENCIA Digital Self-GuidedParticipants 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. |
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGENCIA Digital Self-GuidedAGENCIA 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. | Behavioural | AGENCIA Digital Self-Guided |
| AGENCIA In-person With Digital AssistantAGENCIA 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. | Behavioural | AGENCIA In-person with Digital Assistant |
Primary outcome
SDQ Total Difficulties Score
Time frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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.
10 secondary outcomes
SDQ Subscale Scores (Emotional, Conduct, Hyperactivity/Inattention, Peer, Prosocial)
Time frame: 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: 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: 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: 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: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
Family Accommodation (FASA / FASA-CR Total Score)
Time frame: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Children's Hope Scale - Agency Subscale (CHS-Agency)
Time frame: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Usability, Acceptability, and Satisfaction Questionnaire
Time frame: Within 1 week post-intervention (T1)
Relational Openness / Self-Disclosure
Time frame: Within 1 week post-intervention (T1)
Perceived Alliance (Session Rating Scale, SRS)
Time frame: Within 1 week post-intervention (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available for sharing. Shared data may include scores from primary and secondary outcomes (SDQ, ABC, HoNOSCA-SR, EQ-5D-5L, FASA, CHS), excluding all direct identifiers. Only fully anonymized datasets will be provided. No information that could allow re-identification will be shared.
Related trials for Irritability
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Psychological Treatments for Youth With Severe Irritability.
Irritability
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalia Garrido Torres principal investigator
Andalusian Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGENCIA Digital Self-Guided and AGENCIA In-person With Digital Assistant in people with Irritability and Neurodevelopmental Disorders, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Rosso Fernandez (+34 955 013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDQ Total Difficulties Score (time frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.