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NCT Number: NCT07468214

Digitizing and Automating the Diagnostic Psychiatric Assessment Process

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta

Málaga, 29019, Spain

Location status: Recruiting

Location contact

Irene Lopez Armenteros

CONTACT

[email protected]

687415627

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Content validity

    Time frame: At baseline

    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).

  2. Patient acceptability

    Time frame: At baseline

    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.

  3. Feasibility of the EPSI-C

    Time frame: At baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Lopez Armenteros, PhD student

CONTACT

[email protected]

+34687415627

Marina Romero-González, Doctor

CONTACT

[email protected]

+34665695206

Sponsors and collaborators

Lead sponsor

Irene Lopez Armenteros

Other

Registry information

Acronym: DADAP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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