A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA) (AGENCIA)
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:
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Clara Rosso Fernandez
- Telefonní číslo: +34 955 013414
- E-mail: claram.rosso.sspa@juntadeandalucia.es
Studijní místa
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Seville, Španělsko, 41013
- Hospital Universitario Virgen del Rocio
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Kontakt:
- Nathalia Garrido Torres
- Telefonní číslo: +34 608 30 46 63
- E-mail: nagatorr@gmail.com
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Vrchní vyšetřovatel:
- Nathalia Garrido Torres
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: AGENCIA In-person with Digital Assistant
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.
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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.
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Experimentální: AGENCIA Digital Self-Guided
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.
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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.
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Žádný zásah: Control Digital Psychoeducation
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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SDQ Total Difficulties Score
Časové okno: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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SDQ Subscale Scores (Emotional, Conduct, Hyperactivity/Inattention, Peer, Prosocial)
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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SDQ-Impact Score (Functional Impairment)
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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Aberrant Behavior Checklist (ABC) Subscales
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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HoNOSCA-SR Total Score
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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EQ-5 Dimension-5 Level Index Score (Quality of Life)
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-
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Family Accommodation (FASA / FASA-CR Total Score)
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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Children's Hope Scale - Agency Subscale (CHS-Agency)
Časové okno: Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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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.
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Time Frame: Baseline Day 0 (T0), Within 1 week post-intervention (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
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Usability, Acceptability, and Satisfaction Questionnaire
Časové okno: Within 1 week post-intervention (T1)
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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.
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Within 1 week post-intervention (T1)
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Relational Openness / Self-Disclosure
Časové okno: Within 1 week post-intervention (T1)
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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.
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Within 1 week post-intervention (T1)
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Perceived Alliance (Session Rating Scale, SRS)
Časové okno: Within 1 week post-intervention (T1)
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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.
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Within 1 week post-intervention (T1)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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K-Brief Intelligence Test (Intellectual Functioning)
Časové okno: Baseline Day 0 (T0)
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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.
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Baseline Day 0 (T0)
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ABAS-II (Adaptive Functioning)
Časové okno: Baseline Day 0 (T0)
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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.
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Baseline Day 0 (T0)
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SRS-2 (Autistic Traits)
Časové okno: Baseline Day 0 (T0)
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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.
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Baseline Day 0 (T0)
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CBCL (Child Behavior Checklist)
Časové okno: Baseline Day 0 (T0)
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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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Baseline Day 0 (T0)
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ASQ-14 (Psychosocial Stressors)
Časové okno: Baseline Day 0 (T0)
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Accumulated psychosocial stress measured with the Adolescent Stress Questionnaire-14 (ASQ-14), a 14-item scale assessing exposure to common adolescent stress domains.
Each item is rated on a 5-point scale (1 = not at all stressful to 5 = very stressful), with total scores ranging from 14 to 70.
Higher scores indicate greater stress burden.
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Baseline Day 0 (T0)
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Sociodemographic and Clinical Data
Časové okno: Baseline Day 0 (T0)
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Sociodemographic and clinical information collected for sample characterization and covariate adjustment, including: age, sex assigned at birth, gender identity, racial/ethnic self-identification (White, Black, Roma, Latin American, Arab/Moroccan, Mixed, Asian, other), recruitment source, living situation, educational level and school modality (mainstream, mainstream with support, specific classroom, or special education center), personal neuropsychiatric history (current and past diagnoses), family neuropsychiatric history (first-degree: parents, siblings; second-degree: grandparents, aunts/uncles), current and past psychopharmacological treatments (name, dose, regimen, start/end dates), and history of significant adverse drug reactions (paradoxical reactions to benzodiazepines/sedatives/anesthetics, atypical reactions to other medications).
These are descriptive categorical and continuous variables; no composite score is calculated.
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Baseline Day 0 (T0)
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THRIVE Screener (Social Determinants of Health)
Časové okno: Baseline Day 0 (T0)
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Social determinants of health assessed with the THRIVE Screener (Boston Medical Center), a caregiver-reported questionnaire designed to identify social risk factors in clinical settings.
The screener includes 9 items covering: housing stability (0 = stable, 1 = at risk, 2 = unstable), food security (2 items; 0 = never, 1 = sometimes, 2 = frequently), medication affordability (Yes/No), transportation access to medical appointments (Yes/No), utility payment difficulties (Yes/No), caregiving burden (Yes/No), employment status (Yes/No), and interest in further education (Yes/No).
Items use mixed response formats; higher scores on housing and food security items indicate greater social risk.
This measure is used for sample characterization and covariate adjustment; no composite score is calculated.
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Baseline Day 0 (T0)
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Anthropometric Measures
Časové okno: Baseline Day 0 (T0)
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Height (cm) and weight (kg) collected as general health indicators for sample characterization.
These are continuous measurements reported in their respective units.
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Baseline Day 0 (T0)
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Physiological Biomarkers
Časové okno: During intervention sessions (Days 1-21, approximately)
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Electrodermal activity (skin conductance, µS) and heart rate (beats per minute) continuously recorded using an Empathic wristband device during intervention sessions as potential mechanistic correlates of emotional reactivity and autonomic stress response.
These are continuous physiological measurements; mean, variability, and reactivity indices may be derived for analysis.
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During intervention sessions (Days 1-21, approximately)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Nathalia Garrido Torres, Andalusian Health Service
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AGENCIA TEENS
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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