Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350760
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-19
Brief Title:
Transdiagnostic Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems WAdd-On Modules
Sponsor:
University of Jaén
Organization:
University of Jaén
Study Overview
Official Title:
Transdiagnostic Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules PROCARE-I
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:
PROCARE-I
Brief Summary:
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young peoples risk of developing emotional problems In this study an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population with the following objectives 1 provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I and 2 evaluate if there is any risk factor that predicts anxiety-depressive symptoms andor emotional difficulties The sample was made up of 30 adolescents who showed symptoms of anxiety andor depression and a high risk of developing an emotional disorder and who benefited from the preventive transdiagnostic online and personalized intervention called PROCARE-I After the analysis of the data collected at the pre-intervention and post-intervention time the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology quality of life and emotional regulation On the other hand the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression In contrast predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty
Detailed Description:
The general objetive of PROCARE-I is to implement and evaluate an indicated 8-session preventive group intervention with add-on modules for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression The intervention will be based on the Unified protocol for transdiagnostic treatment of emotional disorders in adolescents UP-A already proven as effective in the US but adapted with indicated prevention purposes in Spain thanks support of main author of the protocol Prf Ehrenreich-May It will be culturally-adapted and designed to be an acceptable scalable and sustainable indicated prevention program
METHODOLOGY In order to achieve this objetive PROCARE-I working plan will be divided into 3 steps Firstly in order to identify adolescents at high risk of suffering emotional disorders anxiety and depression the following self-reports will be administered to adolescents Strengths and Difficulties Questionnaire SDQ to evaluate adolescents at-risk of emotional disorders and the Revised Child Anxiety and Depression Scale-30 RCADS-30 will screen for presenceabsence of emotional symptomatology Then ADIS5-CP will be administered to rule-out presence of anxiety andor mood disorders Valuing voices from stakeholders and end-users the investigators will focus on the study of the influence of the above described variables Third the investigators will test PROCARE-I with add-on modules
IMPACT The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements
METHODOLOGY In order to achieve this objetive PROCARE-I working plan will be divided into 3 steps Firstly in order to identify adolescents at high risk of suffering emotional disorders anxiety and depression the following self-reports will be administered to adolescents Strengths and Difficulties Questionnaire SDQ to evaluate adolescents at-risk of emotional disorders and the Revised Child Anxiety and Depression Scale-30 RCADS-30 will screen for presenceabsence of emotional symptomatology Then ADIS5-CP will be administered to rule-out presence of anxiety andor mood disorders Valuing voices from stakeholders and end-users the investigators will focus on the study of the influence of the above described variables Third the investigators will test PROCARE-I with add-on modules
IMPACT The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements
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