NCT03332966

Brief Summary

This study aims to identify unusual experiences and psychiatric symptoms that indicate a heightened risk for severe mental disorders - especially psychoses. It is important to develop reliable questionnaire methods that are cost-effective in first-stage screening, leading to in-depth assessments and targeted care. However, existing psychosis-risk questionnaires are limited in content, intended for adults, and have been insufficiently tested for actual predictive value. Therefore we will collect a new, large dataset from an unselected group of adolescents entering psychiatric care in three major urban areas of Finland. Comprehensive national health care registers will be used to assess how well the selected experiences and symptoms predict the participants' mental health over the following few years.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

5.1 years

First QC Date

November 1, 2017

Last Update Submit

September 23, 2024

Conditions

Keywords

adolescentoutpatientsquestionnairepsychotic-like symptomspsychosis risk

Outcome Measures

Primary Outcomes (1)

  • First psychosis disorder diagnosis

    National health care register diagnosis of non-organic psychosis

    5 years from recruitment (baseline questionnaire assessment)

Secondary Outcomes (2)

  • Need for psychiatric care

    5 years from recruitment (baseline questionnaire assessment)

  • Psychiatric hospitalization

    5 years from recruitment (baseline questionnaire assessment)

Study Arms (1)

Participants

The adolescent psychiatric organizations of the Helsinki University Central Hospital (serving the capital region's 1.1 million inhabitants), the Tampere University Hospital (catchment area of 500.000 inhabitants), and the Oulu University Hospital (catchment area of 500.000 inhabitants) have agreed to implement the data collection as part of routine intake assessments for patients aged 15-17. All consenting patients are enrolled; the only exclusion criterion is a previous diagnosis of psychotic disorder. The participants fill in psychiatric self-report questionnaires, and their structured diagnostic interview data are collected with their permission.

Diagnostic Test: Psychiatric questionnairesDiagnostic Test: Semi-structured psychiatric interview

Interventions

Participants will fill in the following questionnaires as part of routine intake assessments: Generalised Anxiety Disorder Assessment (GAD-7); Mini-Social Phobia Inventory; Beck Depression Inventory 21A; Pittsburgh Sleep Quality Index; Insomnia Severity Index; Youth Experiences and Health Questionnaire; Adolescent Dissociative Experiences Scale (abbr.); Adolescent Peer Relations Instrument (APRI-B + cyberbullying, abbr.); Adolescent Trauma and Dissociation Scale (abbr.); Alcohol Use Disorders Identification Test; Alcohol, Smoking and Substance Involvement Screening Test - Lite (extended); Nicotine Questionnaire incl. Heavy Smoking Index; Internet Addiction Test (abbr.); European School Survey Project on Alcohol and Other Drugs 2015 Social Media Use and Computer Gaming; McMaster Family Assessment Device - General Functioning positive items; Multidimensional Scale of Perceived Social Support; Brief Resilience Scale; The Short Warwick-Edinburgh Mental Well-Being Scale

Participants

Kiddie Schedule for Affective Disorders and Schizophrenia, version K-SADS-PL 2013.

Participants

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients in the adolescent health clinics in three hospital districts of Finland.

You may qualify if:

  • Start of care in adolescent mental health clinic

You may not qualify if:

  • Previous diagnosis of psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HUS Helsinki University Hospital, adolescent psychiatry clinics

Helsinki, 00029, Finland

NOT YET RECRUITING

Northern Ostrobothnia Hospital District, Adolescent Mental Health Clinic

Oulu, 90230, Finland

RECRUITING

Pirkanmaa Hospital District, Tays Central Hospital, Adolescent psychiatry clinic

Tampere, 33521, Finland

RECRUITING

Related Links

MeSH Terms

Conditions

Psychotic DisordersProdromal SymptomsPsychological Trauma

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Sebastian Therman, PhD

    Sebastian.Therman@THL.fi

    STUDY DIRECTOR
  • Mauri Marttunen, MD, PhD

    Hospital District of Helsinki and Uusimaa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Therman, PhD

CONTACT

Jaana Suvisaari, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

December 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations