Selective Prevention Transdiagnostic Intervention for At-risk Adolescents With Booster Sessions. (PROCARE+ 2.0)

Summary

Emotional disorders such as anxiety and depression are significantly underdiagnosed and undertreated, even though they are some of the most prevalent mental health conditions, especially among young individuals. Approximately 50% of mental health disorders manifest by the age of 14, and around 75% appear by the age of 24, underscoring the critical importance of addressing these issues during adolescence. Unfortunately, during this developmental stage, early warning signs and even fully developed clinical conditions often go unnoticed, undiagnosed, and untreated.

Nonetheless, there is a lack of established, evidence-backed procedures aimed at reaching out to adolescents at risk of developing emotional disorders. Urgently required is a fundamental shift in our approach by creating intervention protocols that allow for the early identification and treatment of at-risk adolescents, thus averting the potential development of severe mental health disorders as they mature. The selective prevention of mental health issues is a crucial element in assisting at-risk adolescents in flourishing before emotional disorders progress. To address this gap, PROCARE+ was conceived as a modularized selective prevention program for adolescents aged 12 to 18 years. Using a personalized medicine approach, PROCARE+ successfully allowed for the adaptation of intervention protocols according to the specific needs of each individual, while also identifying vulnerable individuals based on risk factors. This research aims to maximize and extend the impact on the adolescent population in the post-COVID-19 pandemic stage and will analyze the effectiveness of implementing booster sessions. PROCARE + stratifies adolescents based on their risk and resilience status and will deliver, alongside a core intervention, new specific add-on modules designed to address risk factors identified by adolescents: : 1) Situations of rejection, bullying, and cyberbullying; 2) Addiction to new technologies such as video games or mobile phones and other substances like alcohol, tobacco, and drugs; 3) Improvement of healthy lifestyle habits related to nutrition, sleep, and physical activity; 4) Enhancement of stress-related situations: Ecoanxiety or exam-related anxiety; and 5) Improvement of parent-child relationships and situations of high expressed emotion (parent module).

In addition, the study of booster sessions will be further explored to maintain the results following the initial intervention (which is based on core and additional modules according to identified risk factors). To achieve this, a randomized controlled trial with three conditions will be conducted. Adolescents will be assigned to different experimental groups with or without booster sessions in order to increase the effectiveness of the intervention. The objective is to reduce the impact of risk factors and enhance protective factors, ultimately leading to lasting positive outcomes for adolescents. It will combine quantitative analyses, with a special focus on vulnerable groups in a disaggregated approach by sex, gender, sexual orientation, and socioeconomic status. The PROCARE project is expected to have a significant impact. Its outcomes will continue to contribute to the identification and preventive treatment of adolescents at risk of emotional mental disorders at an early stage, before they incur personal, social, and economic costs. This aims to provide new data to help improve personalized preventive medicine. It will be designed to be an acceptable, scalable, and sustainable selective prevention program, striving to increase its effectiveness beyond the context of the COVID-19 pandemic, ultimately contributing to the prevention and reduction of the prevalence of mental disorders in young people.

Conditions

• Anxiety Disorders and Symptoms Depressive Symptoms
• Risk Factors (Rejection, Bullying/Cyberbullying, Addictions, Healthy Lifestyle Habits, Exam Stress Management, Ecoanxiety, Expressed Emotion)

Interventions

BEHAVIORAL

PROCARE+ (Core intervention with add-on modules) and two booster sessions.

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors. It will include two booster sessions at 6 and 12 months into the intervention.

BEHAVIORAL

PROCARE+ (Core intervention with add-on modules) and one booster session

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors. It will include abooster sessions at 6 months into the intervention.

BEHAVIORAL

PROCARE+ (Core intervention with add-on modules) without booster sessions.

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche

  collaborator OTHER

• University Rovira i Virgili

  collaborator OTHER

• University of Jaén

  lead OTHER

Principal Investigators

• LuisJoaquin Garcia-Lopez, PhD · University of Jaen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-23

Primary Completion

2024-06-01

Completion

2024-06-30

Countries

• Spain

Study Locations