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

June 15, 2023 updated by: Turku University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20700
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional well-being, short-term
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional well-being, long-term
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku
City of Turku

Investigators

  • Principal Investigator: Max Karukivi, MD, PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12086-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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