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Effectiveness of Enhanced Mental Health Support for Young People (Nopsatuki)

Primary Purpose

Depression, Anxiety, Emotional Stress

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intervention
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Anxiety, Intervention, Adolescents, School

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Emotional well-being, long-term
Change from the baseline to the 6 month follow-up time-point 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.

Full Information

First Posted
April 26, 2022
Last Updated
June 15, 2023
Sponsor
Turku University Hospital
Collaborators
University of Turku, City of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT05356949
Brief Title
Effectiveness of Enhanced Mental Health Support for Young People
Acronym
Nopsatuki
Official Title
Effectiveness of Enhanced Mental Health Support for Young People
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku, City of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this study, the impact of a short psychological intervention on adolescent emotional well-being, symptoms, and functioning is assessed. The intervention is a short intervention based on the methods of cognitive-behavioral therapy comprising 6 weekly sessions. It is delivered by psychiatric nurses working in the schools in the City of Turku. The participants are adolescents aged 12-18 who seek student health care due to mental health problems. The goal is to recruit 150 participants. The intervention is not tied to some particular disorder and thus, the main response variable is emotional well-being. Emotional well-being is measured at both the beginning and the end of the intervention, and at 6-month follow-up using the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) questionnaire. Effectiveness is measured as a change in the YP-CORE scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Emotional Stress
Keywords
Depression, Anxiety, Intervention, Adolescents, School

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotional well-being, short-term
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Emotional well-being, long-term
Description
Change from the baseline to the 6 month follow-up time-point 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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Other ongoing mental health treatment Substance use as the main problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Karukivi, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Southwest Finland
ZIP/Postal Code
20700
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Enhanced Mental Health Support for Young People

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