NCT05356949

Brief Summary

The aim of the research project is to measure the effectiveness of an early and rapid psychiatric nurse intervention at schools in improving the emotional well-being and functioning of adolescents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

April 26, 2022

Last Update Submit

June 15, 2023

Conditions

Keywords

DepressionAnxietyInterventionAdolescentsSchool

Outcome Measures

Primary Outcomes (1)

  • Emotional well-being, short-term

    Change from the baseline to the end of the intervention in the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score. The score range for the scale is 0-40 and lower scores indicate better emotional well-being.

    6 weeks

Secondary Outcomes (1)

  • Emotional well-being, long-term

    6 months

Study Arms (1)

Intervention

EXPERIMENTAL

The participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

The participants receive a psychological intervention including six weekly sessions. The intervention is based on methods of cognitive-behavioral therapy and delivered by a psychiatric nurse working in the participant's school.

Intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) score ≥14
  • Willing and able to commit to the intervention and study protocol
  • Sufficient proficiency in Finnish

You may not qualify if:

  • Other ongoing mental health treatment
  • Substance use as the main problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Southwest Finland, 20700, Finland

Location

Related Publications (1)

  • Tornivuori A, Kronstrom K, Aromaa M, Salantera S, Karukivi M. Accessible mental well-being intervention for adolescents in school settings: a single-group intervention study using a pretest-post-test design. Child Adolesc Psychiatry Ment Health. 2023 Feb 20;17(1):28. doi: 10.1186/s13034-023-00576-0.

MeSH Terms

Conditions

DepressionAnxiety DisordersStress, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Max Karukivi, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 2, 2022

Study Start

January 1, 2020

Primary Completion

June 30, 2022

Study Completion

December 31, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations