Validation StudiesDADAPNCT07468214
Digitizing and Automating the Diagnostic Psychiatric Assessment Process
An observational study of Validation Studies and Psychiatric Diagnosis, run by Irene Lopez Armenteros at 1 site in Spain.
Trial summary
This is an observational study that will be responsible for the Spanish translation and cross-cultural adaptation, and validation of the Electronic Semi-Structured Psychiatric Interview for Children and Adolescents (EPSI-C), to examine, classify, prioritize, and diagnose patients. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Studies, Psychiatric Diagnosis
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2026to 1 Feb 2027
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged between 6 and 17 years who present a clinical demand for mental health and are referred from primary care to the community mental health center Málaga Centro.
Who may be able to join
- Families and children aged 6 to 17 with a mental health referral from primary care.
Who cannot join
- Minors under state care without stable attachment figures to report clinical history.
- Presence of global developmental disorder or moderate to severe intellectual disability.
- Incomplete, inaccurate, or unclear medical data.
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, 1 recruiting
- Recruiting
Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta
Málaga, Málaga, 29019
Irene Lopez Armenteros, 687415627, ireloar@gmail.com
About this study
This is an observational study that will be responsible for the Spanish translation and cross-cultural adaptation, and validation of the Electronic Semi-Structured Psychiatric Interview for Children and Adolescents (EPSI-C), to examine, classify, prioritize, and diagnose patients.
Read the detailed description
This study, part of the DADAP project, aims to transform the diagnostic evaluation process in the clinical care pathway of child and adolescent psychiatry (CAP) by digitizing and automating it through an innovative solution based on explainable artificial intelligence that optimizes the delivery of health services and care in a wide range of different settings. This study is a real-world, prospective, multicenter, single-arm observational study that has gathered an international consortium formed by Sweden, Norway, Spain, and Romania. Each participating country is responsible for a specific work package.
Our research team is in charge of WP1, which involves the Spanish translation, validation, and cross-cultural adaptation of the Electronic Semi-Structured Psychiatric Interview for Children and Adolescents (EPSI-C). The semi-structured interview EPSI-C was developed in collaboration between the Child and Adolescent Psychiatric Clinic and the Centre for Clinical Research in Region Västmanland, Sweden. It is based on the DSM-5 diagnostic classification, and it will be used to diagnose young people aged 6 to 17.
The Spanish team is also responsible for WP4, which involves validating the feasibility of the EPSI-C tool both across and within countries through a pilot study, integrating new technologies and artificial intelligence to improve diagnostic processes.
- Conditions
- Validation Studies, Psychiatric Diagnosis
- Keywords
- Cross-cultural adaptation, Child and adolescente psychiatry, mental health care assessment,, Translation, Validation
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and adolescent psychiatric assessment
EPSI-C (Electronic Semi-Structured Psychiatric Interview for Children and Adolescents). A semi-structured diagnostic interview that assesses current episodes of psychopathology in children and adolescents aged 6 to 17 years according to the DSM-5 diagnostic criteria. The mental disorders assessed by the EPSI-C are: specific phobia, separation anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD) and complex PTSD (according to ICD-11 criteria), major and persistent depression, manic/hypomanic episode, anorexia nervosa, bulimia nervosa, binge eating disorder, attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, Tourette's disorder/tics, oppositional defiant disorder, and conduct disorder. It also includes screening for psychotic disorders and self-harm.
Measured: At baseline
Secondary outcomes (3)
Content validity
Questionnaire for the Evaluation of the Content Validity of the EPSI-C. The questionnaire evaluates qualitative assessment (comprehension and wording clarity) and quantitative assessment ( Coherence, clarity, sufficiency, and relevance).
Measured: At baseline
Patient acceptability
Ad-hoc patient questionnaire with open-ended items assessing clarity, relevance, comfort, length, and overall satisfaction
Patient-rated satisfaction and acceptability of the culturally adapted EPSI-C after completing the pilot administration.
Measured: At baseline
Feasibility of the EPSI-C
Feasibility of EPSI-C measured by mean score on an ad-hoc clinician evaluation form (Likert 1-4).
Clinician-rated acceptability, feasibility, and perceived clinical relevance, clarity, and time length after EPSI-C administration in clinical/pilot settings.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Jan 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irene Lopez Armenteros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irene Lopez Armenteros, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Investigators
- Marina Romero-González, Doctor, Principal investigator, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468214
- Sponsor's protocol ID
- DADAP
- Acronym
- DADAP
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected during the pilot studies and will include participants' and clinicians' comments, as well as the results of the psychiatric evaluation interview (EPSIC). All shared data will be anonymized and encrypted to ensure confidentiality and security. Participants will be informed and asked for their consent to share their data with professionals in other countries that are part of the consortium. This will be clearly explained in the informed consent and assent forms.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitizing and Automating the Diagnostic Psychiatric Assessment Process
- ClinicalTrials.gov ID
- NCT07468214
- Acronym / sponsor ID
- DADAP / DADAP
- Conditions
- Validation Studies, Psychiatric Diagnosis
- Keywords
- Cross-cultural adaptation, Child and adolescente psychiatry, mental health care assessment,, Translation, Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Irene Lopez ArmenterosUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 12 Mar 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.
This is an observational study that will be responsible for the Spanish translation and cross-cultural adaptation, and validation of the Electronic Semi-Structured Psychiatric Interview for Children and Adolescents (EPSI-C), to examine, classify, prioritize, and diagnose patients.
Detailed description
This study, part of the DADAP project, aims to transform the diagnostic evaluation process in the clinical care pathway of child and adolescent psychiatry (CAP) by digitizing and automating it through an innovative solution based on explainable artificial intelligence that optimizes the delivery of health services and care in a wide range of different settings. This study is a real-world, prospective, multicenter, single-arm observational study that has gathered an international consortium formed by Sweden, Norway, Spain, and Romania. Each participating country is responsible for a specific work package.
Our research team is in charge of WP1, which involves the Spanish translation, validation, and cross-cultural adaptation of the Electronic Semi-Structured Psychiatric Interview for Children and Adolescents (EPSI-C). The semi-structured interview EPSI-C was developed in collaboration between the Child and Adolescent Psychiatric Clinic and the Centre for Clinical Research in Region Västmanland, Sweden. It is based on the DSM-5 diagnostic classification, and it will be used to diagnose young people aged 6 to 17.
The Spanish team is also responsible for WP4, which involves validating the feasibility of the EPSI-C tool both across and within countries through a pilot study, integrating new technologies and artificial intelligence to improve diagnostic processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged between 6 and 17 years who present a clinical demand for mental health and are referred from primary care to the community mental health center Málaga Centro.
Key inclusion criteria (1 listed)
- Families and children aged 6 to 17 with a mental health referral from primary care.
Key exclusion criteria (3 listed)
- Minors under state care without stable attachment figures to report clinical history.
- Presence of global developmental disorder or moderate to severe intellectual disability.
- Incomplete, inaccurate, or unclear medical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child and adolescent psychiatric assessment
Time frame: At baseline
EPSI-C (Electronic Semi-Structured Psychiatric Interview for Children and Adolescents). A semi-structured diagnostic interview that assesses current episodes of psychopathology in children and adolescents aged 6 to 17 years according to the DSM-5 diagnostic criteria. The mental disorders assessed by the EPSI-C are: specific phobia, separation anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder (PTSD) and complex PTSD (according to ICD-11 criteria), major and persistent depression, manic/hypomanic episode, anorexia nervosa, bulimia nervosa, binge eating disorder, attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, Tourette's disorder/tics, oppositional defiant disorder, and conduct disorder. It also includes screening for psychotic disorders and self-harm.
3 secondary outcomes
Content validity
Time frame: At baseline
Patient acceptability
Time frame: At baseline
Feasibility of the EPSI-C
Time frame: At baseline
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 12 Mar 2026.
- LinkedInLink provided by the sponsor.
- Official webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be collected during the pilot studies and will include participants' and clinicians' comments, as well as the results of the psychiatric evaluation interview (EPSIC). All shared data will be anonymized and encrypted to ensure confidentiality and security. Participants will be informed and asked for their consent to share their data with professionals in other countries that are part of the consortium. This will be clearly explained in the informed consent and assent forms.
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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.
Marina Romero-González, Doctor principal investigator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Studies and Psychiatric Diagnosis, run by Irene Lopez Armenteros 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 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 Irene Lopez Armenteros, PhD student (+34687415627, ireloar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and adolescent psychiatric assessment (time frame: At baseline). 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 12 Mar 2026.