Digitizing and Automating the Diagnostic Psychiatric Assessment Process (DADAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Diagnosis; Validation Studies

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 Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Irene Lopez Armenteros, PhD student; Phone Number: +34687415627; Email: ireloar@gmail.com
• Study Contact Backup: Name: Marina Romero-González, Doctor; Phone Number: +34665695206; Email: Doctoramarinaromero@gmail.com

Study Locations

• Spain
  • Málaga
    • Málaga, Málaga, Spain, 29019
      • Recruiting
      • Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta
      • Contact: Irene Lopez Armenteros; Phone Number: 687415627; Email: ireloar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion criteria:

- Families and children aged 6 to 17 with a mental health referral from primary care.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	At baseline

Collaborators and Investigators

• Sponsor: Irene Lopez Armenteros
• Investigators: Principal Investigator: Marina Romero-González, Doctor, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Publications and helpful links

Helpful Links

• LinkedIn
• Official webpage

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Validation; Translation; Cross-cultural adaptation; Child and adolescente psychiatry; mental health care assessment,
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: DADAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No