NCT06350760

Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules

Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Jaén · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

Summary

PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's 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 and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or 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 presence/absence of emotional symptomatology. Then, ADIS5-C/P will be administered to rule-out presence of anxiety and/or 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.

Conditions

• Anxiety Disorders and Symptoms
• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Active control condition	The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.
BEHAVIORAL	PROCARE-I+ 8-session	The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021. In addition, PROCARE-I+ adds additional modules, which allow adolescents to be provided with tools to address the risk factors they present.

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-05
• Last updated: 2025-09-29

Locations

3 sites across 1 country: Spain