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

• ClinicalTrials.gov Identifier: NCT04851366
• Recruitment Status: Recruiting
• First Posted: April 20, 2021
• Last Update Posted: April 20, 2021
• Sponsor: University of Jaén
• Collaborators: Universidad Miguel Hernandez de Elche; Universitat Rovira i Virgili; University of Miami
• Information provided by (Responsible Party): LuisJoaquin Garcia-Lopez, University of Jaén

Study Description

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

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: LuisJoaquin Garcia-Lopez, PhD; 953213412; ljgarcia@ujaen.es

Contact: JoseAntonio Muela-Martinez, PhD; 953211986; jmuela@ujaen.es

Locations

Spain

Universidad Miguel Hernandez; Recruiting

Elche, Alicante, Spain, 03202

Contact: Jose A Piqueras, PhD 966658343 jpiqueras@umh.es

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 ljgarcia@ujaen.es

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 josefa.canals@urv.cat

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

Investigators

• Principal Investigator: LuisJoaquin Garcia-Lopez, PhD; University of Jaen

More Information

Publications of Results:

García-Escalera J, Valiente RM, Sandín 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.

Sandín B, García-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). pii: E8306. doi: 10.3390/ijerph17228306.

Levin L, Henderson HA, Ehrenreich-May J. Interpersonal predictors of early therapeutic alliance in a transdiagnostic cognitive-behavioral treatment for adolescents with anxiety and depression. Psychotherapy (Chic). 2012 Jun;49(2):218-230. doi: 10.1037/a0028265.

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.

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.

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.

• Responsible Party: LuisJoaquin Garcia-Lopez, Professor, University of Jaén
• ClinicalTrials.gov Identifier: NCT04851366
• Other Study ID Numbers: PID2019-111138RB-I00
• First Posted: April 20, 2021
• Last Update Posted: April 20, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

ADOLESCENCE; TRANSDIAGNOSTIC; SELECTIVE PREVENTION; Randomized-Controlled Trial; AT-RISK

Additional relevant MeSH terms:

Anxiety Disorders; Depression; Mental Disorders; Behavioral Symptoms