Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438276
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-06
Brief Title:
Psychiatric Outreach Nurses Supporting Adolescent Mental Health
Sponsor:
University of Eastern Finland
Organization:
University of Eastern Finland
Study Overview
Official Title:
Supporting Adolescent Mental Health by Psychiatric Outreach Nurses A Mixed Method Evaluation Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAPSY
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 supporttreatment 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
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
Detailed 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 supporttreatment eg 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 supporttreatment 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 Countys 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 adolescents 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 adolescents 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 eg 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 correlationmulticollinearity 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 andor 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 eg 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 persons 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 andor complicated anxiety mood symptoms obsessive-compulsive andor eating disorder symptoms mild to moderate self-harm eg death wishes or cutting In addition the young persons 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 eg 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 andor 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 eg 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
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 supporttreatment 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 Countys 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 adolescents 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 adolescents 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 eg 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 correlationmulticollinearity 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 andor 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 eg 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 persons 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 andor complicated anxiety mood symptoms obsessive-compulsive andor eating disorder symptoms mild to moderate self-harm eg death wishes or cutting In addition the young persons 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 eg 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 andor 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None