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Selective Prevention Transdiagnostic Intervention for At-risk Adolescents (PROCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04851366
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Universidad Miguel Hernandez de Elche
Universitat Rovira i Virgili
University of Miami
Information provided by (Responsible Party):
LuisJoaquin Garcia-Lopez, University of Jaén

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders and Symptoms Depressive Symptoms Behavioral: PROCARE+ (with add-on modules) Behavioral: PROCARE (UP-A for selective purposes) Behavioral: Active control condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
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)
Masking Description: A three-armed simple-blind RCT will be conducted.
Primary Purpose: Prevention
Official Title: Selective PRevention Through transdiagnOstiC Intervention for Adolescents at Risk of Emotional Disorders (PROCARE)
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: PROCARE+ (with add-on modules)
In addition to core UP-A preventive intervention, PROCARE will apply an innovative personalized medicine approach by adding specific modules according to the risk factor evidenced by adolescents. Different modules will be suited for the stratified groups in a more personalized format. Add-on young-focused modules would include, but not limited to social, parental, stress-related (including CoVid19 impact) risk factors, and health. Dosage (number of modules) will be included as covariate in all subsequent analyses.
Behavioral: PROCARE+ (with add-on modules)
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.

Experimental: PROCARE (UP-A for selective purposes)
To ensure cost-effectiveness, PROCARE core intervention will be designed as a brief 8-session child-focused programme which aims to build resilience for adolescents by adapting the core modules from UP-A, along with one individual session with adolescent and parents. Sessions will be delivered in reduced groups, using a typical selective preventive intervention format focused on cost-effectiveness.
Behavioral: PROCARE (UP-A for selective purposes)
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.

Active Comparator: Active control condition.
The active control condition will be based on the "U talk programme" developed by Prf. Jill Ehrenreich-May at University of Miami and colleagues. It follows a similar structure as the UP-A original programme and allows for two alternative compare conditions to PROCARE. The U Talk programme support-based group condition will be used as active control condition.
Behavioral: Active control condition
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.

Primary Outcome Measures :
  1. Self-reported anxiety and mood symptomatology [ Time Frame: Baseline to 12 months after start of interventions ]
    The study's primary outcome was self-reported anxiety and mood symptomatology as assessed by Revised Child Anxiety Depression Scale (RCADS-30). Total scores range from 0 to 90. Higher scores mean a worse outcome.

  2. Factors associated with adolescents' mental health [ Time Frame: 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). Total scores range from 0 to 50. Higher scores mean a worse outcome.

  3. Resilience [ Time Frame: Baseline to 12 months after start of interventions ]
    Self-reported resilience, as measured by Connor-Davidson Resilience Scale (CD-RISC). Total scores range from 0 to 100. Higher scores mean a better outcome.

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Baseline to 12 months after start of interventions ]
    Secondary outcome assessed included self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. Total scores range from 10 to 50. Higher scores mean a better outcome.

  2. Economic evaluations [ Time Frame: Baseline to 12 months after start of interventions ]
    Implementation service costs (training, program materials, provider salaries), costs to school system, and later health costs saved for preventing emotional problems that could narrow cumulative disparities in mental health and disadvantage later in life.

  3. Educational outcome [ Time Frame: Baseline to 12 months after start of interventions ]
    Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.

  4. Emotion regulation skills [ Time Frame: Baseline to 12 months after start of interventions ]
    Emotion regulation skills as assessed by Difficulties in Emotion Regulation Scale-36 (DERS-36). Total scores range from 36 to 180. Higher scores mean a worse outcome.

  5. Psychological flexibility [ Time Frame: Baseline to 12 months after start of interventions ]
    Psychological flexibility as assessed by Willingness and Action Measure for Children and Adolescents (WAM-C/A). Total scores range from 0 to 56. Higher scores mean a better outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • written informed consent from adolescent and legal guardian
  • able to attend prevention modules on his/her own
  • language competence
  • 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
  • absence of anxiety and/or mood disorders
  • evidence of risk factors

Exclusion Criteria:

  • age <12 or >18 years
  • in- or outpatient
  • concomitant psychological/psychiatric treatment
  • acute suicidality
  • general medical contraindications that hamper attendance to prevention modules
  • Strengths and Difficulties Questionnaire "probable diagnoses"
  • score on Connor-Davidson Resilience Scale as high resilient
  • presence of mood and/or anxiety disorders
  • absence of risk factors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04851366

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Contact: LuisJoaquin Garcia-Lopez, PhD 953213412
Contact: JoseAntonio Muela-Martinez, PhD 953211986

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Universidad Miguel Hernandez Recruiting
Elche, Alicante, Spain, 03202
Contact: Jose A Piqueras, PhD    966658343   
Sub-Investigator: Jose A Piqueras, Ph.D.         
Sub-Investigator: Maria Rivera-Riquelme, M.A.         
University of Jaen Recruiting
Jaén, Jaen, Spain, 23071
Contact: LuisJoaquin Garcia-Lopez, PhD    953213412   
Principal Investigator: LuisJoaquin Garcia-Lopez, Ph.D.         
Principal Investigator: Jose A Muela-Martinez, Ph.D.         
Principal Investigator: Lourdes Espinosa-Fernandez, Ph.D.         
Principal Investigator: Manuel Vivas-Fernandez, Ph.D. stud         
Principal Investigator: Eva M Parras-Blanca, M.A.         
Principal Investigator: David Jimenez-Vazquez, M.A.         
Universitat Rovira i Virgili Recruiting
Tarragona, Spain, 43003
Contact: Josefa Canals, M.D.    977257895   
Sub-Investigator: Josefa Canals, M.D.         
Sub-Investigator: Paula Morales-Hidalgo, Ph.D.         
Sponsors and Collaborators
University of Jaén
Universidad Miguel Hernandez de Elche
Universitat Rovira i Virgili
University of Miami
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Principal Investigator: LuisJoaquin Garcia-Lopez, PhD University of Jaen
Publications of Results:

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Responsible Party: LuisJoaquin Garcia-Lopez, Professor, University of Jaén Identifier: NCT04851366    
Other Study ID Numbers: PID2019-111138RB-I00
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LuisJoaquin Garcia-Lopez, University of Jaén:
Randomized-Controlled Trial
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Behavioral Symptoms