Clinical trial NCT06185049: Selective Prevention Transdiagnostic Intervention for At-risk Adolescents With Booster Sessions. (PROCARE+ 2.0)
Official title: Transdiagnostic Selective Preventive Intervention for At-risk Adolescents With Booster Sessions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms Depressive Symptoms
Risk Factors (Rejection, Bullying/Cyberbullying, Addictions, Healthy Lifestyle Habits, Exam Stress Management, Ecoanxiety, Expressed Emotion)
Keywords: ADOLESCENCE
TRANSDIAGNOSTIC SELECTIVE PREVENTION
RISK FACTOR
REJECTION, BULLYING/CYBERBULLYING
ADDICTIONS
HEALTHY LIFESTYLE HABITS
ECOANXIETY
EXAM STRESS
EXPRESSED EMOTION
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: Universidad Miguel Hernandez de Elche
name: University Rovira i Virgili
First posted: 2023-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The effects of an intervention with two booster sessions will be evaluated in parallel with an intervention that only has one booster session and with an intervention without booster sessions.
Primary purpose: PREVENTION

Brief 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.

Detailed description: The general objective of this research is to maximize the benefits of PRCARE+ and assess the effectiveness of implementing booster sessions following the personalized, preventive-selective transdiagnostic intervention in adolescents aged 12 to 18 years.

The core intervention is based on the Unified Protocol for the transdiagnostic treatment of emotional disorders in adolescents (UP-A), which has already demonstrated its effectiveness in the United States but, in this case, adapted for selective prevention purposes. New, enhanced specific modules are provided to address the risk factors identified by the adolescents themselves. Based on the prior stratification of adolescents according to risk and resilience factors, additional specific modules are offered to strengthen emotional regulation, resilience, and coping capacity. Special attention is paid to the effects of booster sessions that allow for the maintenance of intervention outcomes over time. All of this is accomplished through a sequenced approach to skill development, resilience, and explicit implementation guidelines. It is culturally adapted to be acceptable, scalable, and sustainable, contributing to the promotion of emotional mental health in young people.

The specific objectives of this research are as follows:

To identify adolescents at risk of emotional difficulties through a comprehensive analysis of risk and resilience factors. The personalized medicine approach will enable the team to tailor additional intervention modules according to the specific needs of each individual, as well as to determine which risk factors are the best indicators for identifying at-risk youth and/or indicators of program effectiveness.

To enhance the transdiagnostic, preventive-selective, and personalized PROCARE+ intervention for adolescents at risk of developing mental health problems such as anxiety and depression. The preventive program will be adapted from the UP-A protocol for the clinical population, and new additional modules will be applied based on the presented risk factors. This will be implemented through a personalized telemedicine approach. The project has the support of a strong External Advisory Board (EAB): Asociación Española de Ayuda Mutua contra Fobia Social y Trastornos de Ansiedad (AMTAES), Federación Estatal de Lesbianas, Gais, Trans y Bisexuales (FELGTB), Instituto de la Juventud (INJUVE/Ministerio de Asuntos Sociales y Agenda 2030 de España) y Confederación de Organizaciones de Psicopedagogía y Orientación de España (COPOE), Consejo de la juventud de España (CJE).

To demonstrate the cost-effectiveness of booster sessions by designing a trial with three conditions: 1) PROCARE + (Core intervention with add-on modules) and two booster sessions, at 6 and 12 months; 2) PROCARE + (Core intervention with add-on modules) and one booster session, at 6 months; 3) PROCARE + (Core intervention with add-on modules) without booster sessions. All conditions will include baseline, post-test, 6-month, and one-year follow-ups. PROCARE will adhere to internationally adopted guidelines to maximize the reliability of results in preventive trials. The evaluation will combine quantitative and qualitative methods, and the analysis of findings will be conducted: (a) qualitatively, (b) quantitatively, and (c) disaggregated by gender, examining differences between boys and girls and data intersecting with gender (cultural gender norms and emotion regulation skills) that can help explain these differences.

METHODOLOGY The methodology was designed in response to current trends in selective prevention and personalized medicine. The work plan for this research will be divided into three interconnected stages.: Assessment and Stratification; Intervention; and Booster and Follow-up. First, to identify adolescents at risk of experiencing emotional disorders (anxiety and depression), the following questionnaires will be administered to the adolescents: Strengths and Difficulties Questionnaire (SDQ) to assess adolescents at risk of emotional disorders, the Connor-Davidson Resilience Scale (CD-RISC) to assess resilience, the Revised Child Anxiety and Depression Scale-30 (RCADS-30) to detect the presence/absence of emotional symptomatology, the Kidscreen-10 scale for self-reported quality of life assessment, the Difficulties in Emotion Regulation Scale (DERS) as a measure of emotional regulation, and the Willingness and Action Measure for Children and Adolescents (WAM-C/A) as a measure of psychological flexibility. Additionally, potential risk factors will be collected from adolescents and parents through the Climate Anxiety Scale (CAS) by Clayton and Karazsia; Exam Anxiety Questionnaire adapted for Secondary Education (CAEX-A); Cyberbullying and bullying scale; Structured Interview for the Assessment of Expressed Emotion: Child version (E5cv); Video Game Addiction Scale for Adolescents (GASA); Short Version Smartphone Addiction Scale (SAS-SV). These factors will be used for stratification and the adaptation of additional intervention modules according to the specific needs of each subject: (i)to identify individuals at risk and define short- and long-term mechanisms of action for the transdiagnostic, preventive-selective, and personalized PROCARE+ intervention. The researchers will test the effects of booster sessions on the maintenance of the outcomes of a selective preventive intervention using a randomized clinical trial and a personalized medicine approach, with a focus on risk factors and vulnerable youth (refugees, immigrants, or national, ethnic, linguistic, religious, and sexual minorities).

IMPACT The need to prioritize mental health on the public health agenda has been increasingly recognized over the past decades. he results of the research will have a significant impact, ultimately contributing to increasing understanding of the underlying mechanisms of selective prevention of mental disorders in young people and the maintenance of these effects. These problems are extensive, enduring, and of great magnitude, imposing a range of costs on individuals, families, and communities. Prevention will lead to the reduction of personal, social, and economic costs.

Eligibility criteria: Inclusion Criteria:

* written informed consent from adolescent and legal guardian
* able to attend prevention modules on his/her own
* Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
* score on Connor-Davidson Resilience Scale as low or medium resilient,
* score below cut-off for Revised Child Anxiety and Depression Scale-30
* evidence of risk factors (social exclusion, stress-related situations, unhealthy lifestyle habits, parental-child interaction)
* absence of anxiety and/or mood disorders
* not receiving psychological or psychiatric treatment
* not presenting acute suicidality and (9) absence of neurodevelopmental disorders.

Primary outcomes:
measure: The Strengths and Difficulties Questionnaire SDQ
timeFrame: Baseline to 12 months after start of interventions]
measure: Resilience
timeFrame: Baseline to 12 months after start of interventions]
measure: Health-related quality of life
timeFrame: Baseline to 12 months after start of interventions]
Secondary outcomes:
measure: Emotion regulation skills
timeFrame: Baseline to 12 months after start of interventions]
measure: Psychological flexibility
timeFrame: Baseline to 12 months after start of interventions]
measure: Self-reported anxiety and mood symptomatology
timeFrame: Baseline to 12 months after start of interventions]
Other outcomes:
measure: Ecoanxiety
timeFrame: Baseline to 12 months after start of interventions]
measure: Exam anxiety
timeFrame: Baseline to 12 months after start of interventions]
measure: Social exclusion
timeFrame: Baseline to 12 months after start of interventions]
measure: Parental-child interaction
timeFrame: Baseline to 12 months after start of interventions]
measure: video game addiction
timeFrame: Baseline to 12 months after start of interventions]
measure: problematic mobile phone use
timeFrame: Baseline to 12 months after start of interventions]
measure: Health and lifestyle habits
timeFrame: Baseline to 12 months after start of interventions]
Locations:
city: Jaén
country: Spain
facility: University of Jaen
state: Jaen
Study officials:
affiliation: University of Jaen
name: LuisJoaquin Garcia-Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14.
citation: Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.
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citation: Queen AH, Barlow DH, Ehrenreich-May J. The trajectories of adolescent anxiety and depressive symptoms over the course of a transdiagnostic treatment. J Anxiety Disord. 2014 Aug;28(6):511-21. doi: 10.1016/j.janxdis.2014.05.007. Epub 2014 Jun 2.
citation: Bilek EL, Ehrenreich-May J. An open trial investigation of a transdiagnostic group treatment for children with anxiety and depressive symptoms. Behav Ther. 2012 Dec;43(4):887-97. doi: 10.1016/j.beth.2012.04.007. Epub 2012 May 1.
citation: Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.
citation: Vivas-Fernandez M, Garcia-Lopez LJ, Piqueras JA, Muela-Martinez JA, Canals-Sans J, Espinosa-Fernandez L, Jimenez-Vazquez D, Diaz-Castela MDM, Morales-Hidalgo P, Rivera M, Ehrenreich-May J. Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders. Child Adolesc Psychiatry Ment Health. 2023 Jun 23;17(1):77. doi: 10.1186/s13034-023-00616-9.