Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06438276 |
| Other study ID # |
JAPSY_20230 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 6, 2024 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Eastern Finland |
| Contact |
Anne Surakka, M.Soc.Sc, MHS (Health Econ.) |
| Phone |
+358505292553 |
| Email |
anne.surakka[@]uef.fi |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Quantitative research data will be used to evaluate the effectiveness of the psychiatric
outreach care compared to conventional care (TAU). Psychiatric outreach registered nurses are
currently available in some schools in several municipalities in the North Savo region in
Finland. In the other schools, support is provided by so-called "usual" counselling and other
support/treatment, e.g. by public health nurses, school social workers, school psychologists
and school doctors.
The study design is a clustered controlled setting. The target sample size for quantitative
data is 160 participants. The intervention group (n = 80) will consist of pupils receiving
support/treatment from psychiatric outreach nurses. The control group (n = 80) will consist
of pupils whose schools provide standard student welfare services and whose mental health
status and support needs are similar to those of the intervention group.
The data will be collected through questionnaires administered to secondary school pupils to
assess their mental health status and quality of life. The adolescents' service use in terms
of student welfare services as well as Wellbeing Services County's social and health care
services will be collected through questionnaires. At baseline, the use of services will be
surveyed retrospectively over a six-month period.
The primary outcome variable of the intervention is the adolescent's perceived mental health
status as assessed by the PHQ-9-A (Patient Health Questionnaire) measure of depression and
the GAD-7 (generalized anxiety disorder) measure of anxiety. The secondary outcome variables
are the adolescent's perceived quality of life (EQ-5D-Y, five dimensional quality of life
measure) and substance use (ADSUME, Adolescents´ Substance Use Measurement). The study will
primarily investigate the effect of psychiatric outreach nurses on treatment response.
Secondarily, subgroups of at least 20 participants will be examined (e.g. controls for
gender, age or other background variables).
Participants are assigned to the intervention or control group based on whether the services
of an psychiatric outreach nurse is available in their school (intervention) or not
(control).
For similarities and differences between the intervention and control groups, a descriptive
analysis is performed using the chi-square test to compare categorical variables and the
t-test or Mann-Whitney U-test to compare continuous variables. The effectiveness of the
intervention will be analysed using statistical methods appropriate for panel data, taking
into account the effects of possible correlation/multicollinearity on the results.
Statistical methods will be used to control for the possible selection of a non-standardised
design by including control variables in the models.
The economic evaluation of the intervention will use data on the use of social and health
services, student welfare services and the cost of the intervention. Data on the costs of the
intervention will be obtained from the Wellbeing Services County of North Savo. The costs of
health and social services and student welfare services are calculated on the basis of the
number of services used and the unit costs. The cost-effectiveness of the intervention is
analysed in relation to the treatment as usual provided by student welfare services using
incremental net monetary benefit or incremental net health benefit evaluation to examine
differences in costs and/or health benefits between groups and in the above-mentioned
outcomes at 6-month and 12-month follow-up. Primarily, the economic evaluation will use the
EQ-5D-Y measure to calculate quality-weighted life-years. In addition, the results of the
PHQ-9-A, GAD-7 and ADSUME measures will be analysed.
Eligibility Criteria: Pupils (12-16 years old) who seek help from a student welfare service
due to mood disorders. In addition, a representative of the student welfare service (e.g. a
public health nurse, school social worker, psychologist or doctor) or a representative of the
student welfare service and an psychiatric outreach nurse assess together a person's
eligibility for the study, taking into account the inclusion and exclusion criteria.
Inclusion criteria for the intervention and control groups will be one or more of the
following symptoms: 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, the young person's motivation to receive the service is an admission criterion.
Exclusion criteria: The psychiatric outreach nurse service is not suitable for persons with
one or more of the following needs or life situations: pupils 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, the service is not
intended for pupils who are in acute need of specialist care or for pupils 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). Exclusion criteria for the intervention and
control groups also include situations where the young person has a long-lasting, already
established mental health problem and/or a need for further treatment after a period of
specialised hospital care. Exclusion criteria also include behavioural disorders where there
is a clear underlying cause other than a mental disorder.
The qualitative perspective of the study focuses on those implementing the service
(psychiatric outreach nurses) and their collaborators in schools (e.g. school social workers,
public health nurses, school psychologists, doctors and teachers). The total number of
interviewees is estimated to be 15-20. Data collection consists of individual semi-structured
interviews to describe the interviewees' experiences of applying the new service approach in
the school setting. As the approach is new in the Wellbeing Services County of North Savo, it
is necessary to explore the experiences of both those implementing as well as their
collaborators in terms of introducing the service, operation of the service, the perceived
needs for the service as well as the needs for development of the service. The interviews
will be carried out at the beginning of the study and at 12-month follow-up.
