NCT07468214

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 9, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 12, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 27, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Cross-cultural adaptationChild and adolescente psychiatrymental health care assessment,TranslationValidation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Content validity

    At baseline

  • Patient acceptability

    At baseline

  • Feasibility of the EPSI-C

    At baseline

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Málaga, Málaga, 29019, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Marina Romero-González, Doctor

    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Lopez Armenteros, PhD student

CONTACT

Marina Romero-González, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Predoctoral investigator

Study Record Dates

First Submitted

January 27, 2026

First Posted

March 12, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations