Selective Prevention Transdiagnostic Intervention for At-risk Adolescents
Condition: Anxiety Disorders and Symptoms; Depressive Symptoms
MeSH terms: Anxiety Disorders; Depression
Study type: Interventional

Summary: 
      Emotional disorders (anxiety and/or depression) are severely undiagnosed and untreated
      despite being among the most common mental disorders, particularly at a young age. Half of
      all mental disorders begin by age 14; three-quarters by age 24, which makes adolescence a
      particularly crucial stage. In adolescence, prodromal signs of mental disorders and even
      full-blown clinical conditions often remain undetected, undiagnosed and untreated. However,
      there is an absence of evidence-based protocols to reach at-risk youth for developing
      emotional disorders. There is an urgent need for a paradigm shift by developing intervention
      protocols to early identify and treat at-risk adolescents, thus preventing them from
      developing severe mental disorders later on in life. Mental health selective prevention is
      key to helping at-risk adolescents thrive before emotional disorder evolves. To cover this
      gap, PROCARE is conceptualized as a modularized selective preventive programme for
      adolescents aged 12 to 18 years. Using personalized medicine approach, PROCARE will allow to
      tailor intervention protocols according to the particular needs of an individual, but also to
      identify vulnerable people according to risk factors. Adolescents will be stratified based on
      risk and resilience status and allocated to a 3-arm intervention trial, delivered as a group,
      face-to-face or telehealth format, depending on Covid19 restrictions imposed by government.
      By the very first time, PROCARE as selective intervention for at-risk adolescents will
      deliver specific add-on modules to tackle risk factors evidenced by adolescents, along with a
      core intervention. The PROCARE protocol aims to reduce the effect of risk factors and enhance
      protective factors that will eventually lead to lasting positive effects for adolescents.
      PROCARE will combine quantitative analysis, with special attention to vulnerable groups in a
      sex/gender disaggregated way. The PROCARE project is expected to have a far impact ultimately
      contributing to preventing and reducing the prevalence of mental disorders in the young. The
      outcomes of PROCARE will contribute to identifying and treating adolescents at risk for
      emotional mental at an early stage, before they incur personal, societal and economic cost.
      PROCARE will be culturally-adapted and implemented as a multicenter Randomized-Controlled
      Trial (RCT). PROCARE will be designed to be an acceptable, scalable, and sustainable
      selective prevention program.
    

Detailed description: 
      OBJECTIVES The general objective of PROCARE is to design, implement and evaluate a selective
      preventive intervention for adolescents aged 12-18 at risk of emotional disorders like
      anxiety and depression. The core 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 selective prevention purposes thanks support of main
      author of the protocol (Prf. Ehrenreich-May). By the very first time, PROCARE as selective
      intervention for at-risk adolescents will deliver specific add-on modules to tackle risk
      factors evidenced by adolescents. So, PROCARE will be flanked with a preliminary risk and
      resilience factor stratification, according to the identified users' and stakeholders' needs
      in order to empower emotional regulation, building resilience and coping capacities. It will
      be culturally-adapted and designed to be an acceptable, scalable, and sustainable selective
      prevention program.

      The specific objectives of the PROCARE project are:

        -  To identify adolescents at risk for emotional difficulties via a thorough screening risk
           and resilience factor analysis. The personalised medicine approach will allow the team
           to tailor add-on intervention modules according to the particular needs of every subject
           but also to know what risk factors are the best indicators to identify young people at
           risk and/or indicators of the effectiveness of the programme.

        -  To implement a selective preventive transdiagnostic intervention for adolescents at risk
           of developing mental health problems like anxiety and depression that will serve as a
           gold standard in the field. The preventive programme will be adapted from the UP-A
           protocol for clinical population; tailoring it to the specific requirements of recruited
           adolescents with add-on modules according to the risk factors presented. Thanks to 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/Spanish MInistry of
           Social Affairs and Agenda 2030) & Confederación de Organizaciones de Psicopedagogía y
           Orientación de España (COPOE), PROCARE will be designed to be an acceptable, scalable,
           and sustainable face-to-face selective prevention program for use in culturally-diverse
           school setting, avoiding stigmatization or via telehealth, depending on governmental
           restrictions due to pandemia.

        -  To demonstrate cost-effectiveness of the intervention using a rigorous scientific
           method. Designed as a three-arm RCT (Arm 1 = Active Control group; Arm 2 = PROCARE
           without add-on modules (UP-A adapted for selective prevention); Arm 3 = PROCARE with
           add-on modules;) and a baseline, post-test, 6-month and one-year follow-up, PROCARE will
           meet internationally adopted guidelines to maximise the reliability of results in
           preventive trials.

        -  To facilitate the replication of the programme based on a well-defined methodology and
           analysis plan and elaborate practice guidelines for mental health problems amongst
           adolescents. These guidelines will be used as a gold standard for prevention. The
           evaluation will combine quantitative and qualitative methods and the analysis of the
           findings: (a) in a qualitative way, (b) in a quantitative way and (c) in a sex
           disaggregated way, by examining differences between boys and girls and data intersecting
           with sex (cultural gender norms and emotion regulation skills) that can help to explain
           these differences.

      The preventive approach outlined in PROCARE is aimed at serving as a blueprint to timely
      detect and intervene in young people at risk and to contribute to the promotion of emotional
      mental health in the young.

      The PROCARE project will bundle the resources for the improvement of health and wellbeing at
      early ages. This action will be focused on preventing emotional problems by a sequenced
      approach to skill development, resilience, an explicit implementation guidelines and
      effective training to mental health providers.

      METHODOLOGY The methodology was designed in order to achieve the project's objective of
      presenting a novel approach to treating adolescents at risk of developing emotional
      disorders, in response to current trends for selective prevention and personalized medicine.
      PROCARE working plan will be divided into 3 interconnected stages. Firstly, in order to
      identify adolescents at 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, the
      Connor-Davidson Resilience Scale (CD-RISC) to assess resilience, and the Revised Child
      Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional
      symptomatology. Second, putative risk factors will be collected by adolescents, parents and
      teachers in those adolescents who are retained. These factors will serve for stratification
      for tailoring add-on intervention modules according to the particular needs of every subject
      but also to know which risk factors are the best indicators to: (i) identify subjects at
      risk, (ii) predict response to the selective preventive intervention (PROCARE) and to (iii)
      define short- and long-term mechanisms of action of the selective preventive intervention
      (PROCARE). 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 a selective preventive intervention using multi-center randomized control trial and
      personalised medicine approach. Special attention will be paid to particularly vulnerable
      young people, such as disabled, refugees, immigrants, or minorities (national, ethnic,
      linguistic, religious, and sexual).

      IMPACT The need to include mental health among the first priorities of the public health
      agenda has been increasingly recognized over the past decades. The outcomes of the PROCARE
      project will have a far impact ultimately contributing to preventing and reducing the
      prevalence of mental disorders in the young. These problems are wide-ranging, long-lasting,
      and enormous and impose a range of costs on individuals, families and communities. The
      outcomes of the project, if successful, will have far reaching implications, contributing to
      identifying and treating adolescents at risk for emotional mental at an early stage, before
      they incur personal, societal and economic cost.
    

Intervention name(s): PROCARE+ (with add-on modules); PROCARE (UP-A for selective purposes); Active control condition
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The modules will mainly consist in therapy sessions to provide the adolescents with tools to confront risk situations such as communication skills, coping skills to manage stress, etc. The group will include education about discussing thoughts, feelings, and behaviour as parts of emotion, and emphasis on providing support around the specific risks factors detected.; This core intervention is meant to respond to the heterogeneity inherent in emotional difficulties presentation by extinguishing distress associated with the presentation of heightened negative emotion in general and reduction or elimination of resultant emotionally-driven behaviours, including avoidance, escape, aggression, and controlling behaviours (e.g., reassurance seeking) that reinforce emotional distress intensity over time.; Psychoeducation about many different emotions, emphasis on discussing thoughts, feelings, and behavior as parts of emotion, and emphasis on providing support around generally distressing events.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Two interventions are evaluated in parallel against a active control group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ADOLESCENCE; TRANSDIAGNOSTIC; SELECTIVE PREVENTION; Randomized-Controlled Trial; AT-RISK