Anxiety Disorders and SymptomsPROCARENCT04851366
Selective Prevention Transdiagnostic Intervention for At-risk Adolescents
A study testing PROCARE+ (with add-on modules) and PROCARE (UP-A for selective purposes) in people with Anxiety Disorders and Symptoms and Depressive Symptoms, run by University of Jaén at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms, Depressive Symptoms
- What is being tested?
- PROCARE+ (with add-on modules) and PROCARE (UP-A for selective purposes)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Show all 9Show fewer
- absence of anxiety and/or mood disorders
- not receiving psychological or psychiatric treatment
- not presenting acute suicidality and (9) absence of neurodevelopmental disorders.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Universidad Miguel Hernandez
Elche, Alicante, 03202
University of Jaen
Jaén, Jaen, 23071
Universitat Rovira i Virgili
Tarragona, 43003
About this study
Official title: Selective PRevention Through transdiagnOstiC Intervention for Adolescents at Risk of Emotional Disorders (PROCARE)
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.
Read the 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.
- Being tested
- PROCARE+ (with add-on modules), PROCARE (UP-A for selective purposes), Active control condition
- Keywords
- ADOLESCENCE, TRANSDIAGNOSTIC, SELECTIVE PREVENTION, Randomized-Controlled Trial, AT-RISK
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCARE+ (with add-on modules)Behavioural
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.
PROCARE (UP-A for selective purposes)Behavioural
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 control conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PROCARE+ (with add-on modules) | Experimental | 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. Receives: Behavioral: PROCARE+ (with add-on modules) |
| PROCARE (UP-A for selective purposes) | Experimental | 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. Receives: Behavioral: PROCARE (UP-A for selective purposes) |
| Active control condition. | Active comparator | 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. Receives: Behavioral: Active control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with adolescents' mental health
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.
Measured: Baseline to 12 months after start of interventions
Resilience
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.
Measured: Baseline to 12 months after start of interventions
Health-related quality of life
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.
Measured: Baseline to 12 months after start of interventions
Secondary outcomes (3)
Emotion regulation skills
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.
Measured: Baseline to 12 months after start of interventions
Psychological flexibility
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.
Measured: Baseline to 12 months after start of interventions
Self-reported anxiety and mood symptomatology
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.
Measured: Baseline to 12 months after start of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two interventions are evaluated in parallel against a active control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche, University Rovira i Virgili, University of Miami
- Responsible party
- Principal investigator, LuisJoaquin Garcia-Lopez, University of Jaén
- Investigators
- LuisJoaquin Garcia-Lopez, PhD, Principal investigator, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851366
- Sponsor's protocol ID
- PID2019-111138RB-I00
- Acronym
- PROCARE
- Status last verified
- Dec 2023
- First submitted
- 11 Apr 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32402261Sandin 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.
PubMed 33182711Levin 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.
PubMed 22642525Queen 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.
PubMed 24960439Bilek 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.
PubMed 23046789Ehrenreich-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.
PubMed 27771133
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective PRevention Through transdiagnOstiC Intervention for Adolescents at Risk of Emotional Disorders (PROCARE)
- ClinicalTrials.gov ID
- NCT04851366
- Acronym / sponsor ID
- PROCARE / PID2019-111138RB-I00
- Keywords
- ADOLESCENCE, TRANSDIAGNOSTIC, SELECTIVE PREVENTION, Randomized-Controlled Trial, AT-RISK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche, University Rovira i Virgili, University of Miami
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Two interventions are evaluated in parallel against a active control group
| Arm | Type | Receives |
|---|---|---|
| PROCARE+ (with add-on modules) | Experimental | Behavioral: 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. |
| PROCARE (UP-A for selective purposes) | Experimental | Behavioral: 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. |
| Active control condition. | Active comparator | Behavioral: Active control conditionThe 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PROCARE+ (with add-on modules) |
| 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. | Behavioural | PROCARE (UP-A for selective purposes) |
| Active control conditionPsychoeducation about many different emotions, emphasis on discussing thoughts, feelings, and behavior as parts of emotion, and emphasis on providing support around generally distressing events. | Behavioural | Active control condition. |
Primary outcome
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.
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.
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.
3 secondary outcomes
Emotion regulation skills
Time frame: Baseline to 12 months after start of interventions
Psychological flexibility
Time frame: Baseline to 12 months after start of interventions
Self-reported anxiety and mood symptomatology
Time frame: Baseline to 12 months after start of interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Results publication: PubMed 32402261Garcia-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.
- Results publication: PubMed 33182711Sandin 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.
- Results publication: PubMed 22642525Levin 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.
- Results publication: PubMed 24960439Queen 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.
- Results publication: PubMed 23046789Bilek 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.
- Results publication: PubMed 27771133Ehrenreich-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LuisJoaquin Garcia-Lopez, PhD principal investigator
University of Jaen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROCARE+ (with add-on modules) and PROCARE (UP-A for selective purposes) in people with Anxiety Disorders and Symptoms and Depressive Symptoms, run by University of Jaén at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with adolescents' mental health (time frame: Baseline to 12 months after start of interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851366, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.