Transdiagnostic Selective Preventive Intervention for At-risk Adolescents With Booster Sessions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Health-related quality of life
时间窗: Baseline to 12 months after start of interventions]
Self-reported changes in health-related quality of life as assessed by self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. This instrument contains 10 items with a Likert-type response form ranging from 1 to 4. Total scores range from 10 to 40. Higher scores mean a better outcome.
The Strengths and Difficulties Questionnaire SDQ
时间窗: Baseline to 12 months after start of interventions]
The study's primary outcome was self-reported risk and protective factors level of emotional disorders as assessed by Strengths and Difficulties Questionnaire (SDQ). Only 5 items of the emotional problems subscale of the self-reported version for adolescents (Self-Reported SDQ) was used. And 5 items of the emotional problems subscale of the parent version (Parent SDQ). Items with Likert-type response format scored from 0 to 2. Higher scores mean a worse outcome.
Resilience
时间窗: Baseline to 12 months after start of interventions]
Self-reported resilience, as measured by Connor-Davidson Resilience Scale (CD-RISC-10).10 items with a Likert-type response format from 0 to 4. Total scores range from 0 to 40. Higher scores mean a better outcome.
次要结局
- Self-reported anxiety and mood symptomatology(Baseline to 12 months after start of interventions])
- Emotion regulation skills(Baseline to 12 months after start of interventions])
- Psychological flexibility(Baseline to 12 months after start of interventions])
研究者
LuisJoaquin Garcia-Lopez
Professor
University of Jaén
