NCT06438276

Brief Summary

The study evaluates the effectiveness and cost-effectiveness of the outreach work of psychiatric registered nurses (RN) and the experiences of professionals in the field. The service is provided in school environment. First, the study will assess the effectiveness of brief interventions provided by psychiatric outreach nurses on the perceived mental health and quality of life of adolescents (12-16 year old pupils) and their use of social and health services, compared to the support/treatment provided by conventional student welfare services at 6 and 12 months follow-up. The intervention is an outreach service provided by psychiatric nurses. In the intervention, the psychiatric registered nurse will implement interventions such as usual care, discussion, psychoeducation, substance abuse skills and various methods (such as interpersonal psychotherapy = IPT-N and Cool Kids) and motivational interviewing. Secondly, an economic evaluation of the service will be carried out at 6 and 12 months follow-up. The economic evaluation will be carried out from the perspective of the Wellbeing Services County, including the costs of implementing the intervention model and its effects on adolescents' use of student welfare services as well as other social and health services. Primarily, the economic evaluation will use quality-weighted life years as a measure of effectiveness. Also analysis using depression, anxiety and substance use measures will be conducted. Thirdly, the study will explore the experiences of psychiatric nurses implementing the service as well as the experiences of their collaborators in schools (public health nurses, school social workers, psychologists, doctors and teachers) about the service and its implementation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started May 2024

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Progress80%
May 2024Dec 2026

First Submitted

Initial submission to the registry

May 6, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

May 6, 2024

Last Update Submit

May 24, 2024

Conditions

Keywords

mental healthmental disordersadolescentoutreach serviceschool-basedeffectivenesseconomic evaluation

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire modified for adolescent to measure perceived mental health

    The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Patient Health Questionnaire modified for adolescent (PHQ-9-A) measure of depression in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 27. Higher scores is worse outcome.

    6-month and 12-month follow-up

  • Generalized Anxiety Disorder 7-item to measure adolescent's perceived mental health

    The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Generalized Anxiety Disorder 7-item (GAD-7) measure of anxiety in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 21. Higher scores is worse outcome.

    6-month and 12-month follow-up

Secondary Outcomes (2)

  • EuroQol-5-Dimension 3-Level modified for adolescent to measure perceived quality of life

    6-month and 12-month follow-up

  • Adolescents' Substance Use Measurement to measure substance use

    6-month and 12-month follow-up

Study Arms (1)

Adolescents with mood disorders seeking help in student welfare services

Intervention group receiving psychiatric outreach nurse services: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have access to psychiatric outreach nurse's service. Control group receiving TAU: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have no access to psychiatric outreach nurse's service.

Behavioral: Psychiatric outreach nurse service

Interventions

Mental health service provided by psychiatric outreach nurses for 12-16 year old students in secondary schools

Adolescents with mood disorders seeking help in student welfare services

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Adolescent (12-16 year old) students of secondary schools in the municipalities of North Savo Wellbeing County who seek help from student welfare services due to mood disorders.

You may qualify if:

  • Adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and who have one or more of the following conditions: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, person's motivation to receive the service provided is an admission criterion.

You may not qualify if:

  • Persons with one or more of the following needs or life situations: adolescents who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, adolescents who are in acute need of specialist care or for adolescents with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellbeing Services County of North Savo

Kuopio, Northern Savonia, Finland

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-BeingMental Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Johanna Lammintakanen, PhD, Professor

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Surakka, M.Soc.Sc, MHS (Health Econ.)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 31, 2024

Study Start

May 6, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations