Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390462
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-19
Brief Title:
Adolescent Interpersonal Counseling in Primary Care
Sponsor:
Finnish Institute for Health and Welfare
Organization:
Finnish Institute for Health and Welfare
Study Overview
Official Title:
Adolescent Depression Treatment Pathways in Primary Care - a Longitudinal Cohort Study Describing Naturalistic Flow of Treatment and Evaluating Effectiveness and Cost-effectiveness of Interpersonal Counseling Compared to Treatment as Usual
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The demand for prevention and treatment of adolescent depression has rapidly increased over years A national project to improve treatment of adolescent depression in primary care has taken place in Finland starting 2020
The goal of this prospective observational cohort study is to describe pathways to mental health services in adolescents with depressive symptoms The main questions it aims to answer are
Do young people reporting depressive symptoms have equal access to treatment
How is it best to recognize those adolescents who will benefit from IPC-A
Adolescents who participate in the study will
complete a survey on protective and risk factors of depression three times over 6 months
report possible depressive symptoms every two weeks over 6 months
report whether they needed and received help motivation for treatment and benefits and harms from treatment
We will also collect
information from one of caretakers with two surveys within 6 month- intervals on their view on adolescents need for support strengths and risks and benefits and harms from treatment where applicable
where applicable from the professional who provided support after the intervention on their training and competence as well as content of and response to treatment
register data to estimate overall provision and cost of social welfare and health care services one year preceding the study and over 2 to 10 years after the observation period
Researchers will compare an intervention that is new in Finland adolescent interpersonal counseling IPC-A to other treatments of depression to see if it is equal to or better than other treatments of depression
The goal of this prospective observational cohort study is to describe pathways to mental health services in adolescents with depressive symptoms The main questions it aims to answer are
Do young people reporting depressive symptoms have equal access to treatment
How is it best to recognize those adolescents who will benefit from IPC-A
Adolescents who participate in the study will
complete a survey on protective and risk factors of depression three times over 6 months
report possible depressive symptoms every two weeks over 6 months
report whether they needed and received help motivation for treatment and benefits and harms from treatment
We will also collect
information from one of caretakers with two surveys within 6 month- intervals on their view on adolescents need for support strengths and risks and benefits and harms from treatment where applicable
where applicable from the professional who provided support after the intervention on their training and competence as well as content of and response to treatment
register data to estimate overall provision and cost of social welfare and health care services one year preceding the study and over 2 to 10 years after the observation period
Researchers will compare an intervention that is new in Finland adolescent interpersonal counseling IPC-A to other treatments of depression to see if it is equal to or better than other treatments of depression
Detailed Description:
Background Implementation of evidence-based interventions is one of the proposed responses to increased demand for prevention and treatment of adolescent depression A national implementation of adolescent interpersonal counseling IPC-A has taken place in Finland starting 2020 While the efficacy of interpersonal psychotherapy IPT-A as an intervention to treat depression of adolescents is well established the effectiveness and cost-effectiveness of the shorter adaptation IPC-A remains open Investigators present a protocol for an evaluation of pathways to mental health services of depressed adolescents and a prospective observational community-based cohort study to estimate the effectiveness and cost-effectiveness of IPC-A as compared to adolescents with sustained depression with treatment as usual or no treatment
Methods The cohort will include grade 7 to 9 adolescents 13-16-year-olds in selected Finnish schools excluding adolescents with preceding treatment of depression A universal prospective evaluation of adolescents in a 6-month follow-up will provide information on the proportion of adolescents a with sustained depression over the follow-up period Patient Health Questionnaire 9 items PHQ-9 10 in two measurements over 6 months b with a self-reported need for support due to depressive symptoms and c with a therapeutic intervention The investigators will describe the treatment received number of sessions therapeutic content based on reports from adolescents caretakers and therapists as well as electronic patient records The primary outcome measure will be the proportion of adolescents who will receive specialized psychiatric services by 12 months after baseline Secondary outcome measures comparing three groups as defined at 6 months IPC-A treatment as usual TAU or no treatment group They will include proportion of adolescents who received any support by 12 months after baseline and longitudinal changes in PHQ-9-A scores by 12 months Cost-effectiveness will be evaluated using survey data at 12 months and an economic evaluation using register data and information on service use 12 months before and 2 and 10 years after baseline Collection of survey data is expected to start in March 2024 and is set to finish in May 2025
Discussion The study will describe need for pathways to and content of social and health services for depressed adolescents Benefits and harms of treatment and the national implementation will be observed The results can improve detection and equal access to care and inform decision-makers about the best practices for prevention including utility of the implementation of IPC-A
Methods The cohort will include grade 7 to 9 adolescents 13-16-year-olds in selected Finnish schools excluding adolescents with preceding treatment of depression A universal prospective evaluation of adolescents in a 6-month follow-up will provide information on the proportion of adolescents a with sustained depression over the follow-up period Patient Health Questionnaire 9 items PHQ-9 10 in two measurements over 6 months b with a self-reported need for support due to depressive symptoms and c with a therapeutic intervention The investigators will describe the treatment received number of sessions therapeutic content based on reports from adolescents caretakers and therapists as well as electronic patient records The primary outcome measure will be the proportion of adolescents who will receive specialized psychiatric services by 12 months after baseline Secondary outcome measures comparing three groups as defined at 6 months IPC-A treatment as usual TAU or no treatment group They will include proportion of adolescents who received any support by 12 months after baseline and longitudinal changes in PHQ-9-A scores by 12 months Cost-effectiveness will be evaluated using survey data at 12 months and an economic evaluation using register data and information on service use 12 months before and 2 and 10 years after baseline Collection of survey data is expected to start in March 2024 and is set to finish in May 2025
Discussion The study will describe need for pathways to and content of social and health services for depressed adolescents Benefits and harms of treatment and the national implementation will be observed The results can improve detection and equal access to care and inform decision-makers about the best practices for prevention including utility of the implementation of IPC-A
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