Anxiety Disorders and SymptomsPROCARE-I+NCT06350760
Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules
A study testing PROCARE-I+ 8-session in people with Anxiety Disorders and Symptoms and Depressive Symptoms, run by University of Jaén at 3 sites in Spain.
Trial summary
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the… 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-I+ 8-session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Mar 2023to 31 Dec 2025
- 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
- language competence
- Strengths and Difficulties Questionnaire ""probable diagnoses"
- score above cut-off for Revised Child Anxiety and Depression Scale-30
- having incipient symptoms on an emotional level in ADIS 5 C/P
- absence of anxiety and/or mood disorders
Who cannot join
- in- or outpatient
- concomitant psychological/psychiatric treatment
- acute suicidality
- general medical contraindications that hamper attendance to prevention modules
- have been diagnosed with a neurodevelopmental disorder
- Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
- presence of mood and/or anxiety disorders
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Universidad Miguel Hernández
Elche, Alicante, 03202
University of Jaén
Jaén, Jaen, 23071
Universitat Rovira i Virgili
Tarragona, Tarragona, 43003
About this study
Official title: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty.
Read the detailed description
The general objetive of PROCARE-I+ is to implement and evaluate an indicated 8-session preventive group intervention with add-on modules for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The 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 indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program.
METHODOLOGY: In order to achieve this objetive, PROCARE-I+ working plan will be divided into 3 steps. Firstly, in order to identify adolescents at high 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, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Then, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. 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 PROCARE-I with add-on modules.
IMPACT: The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements.
- Being tested
- Active control condition, PROCARE-I+ 8-session
- Keywords
- transdiagnostic, emotional disorders, anxiety, depression, adolescents, child and youth population, indicated prevention
- 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.
Active control conditionBehavioural
The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.
PROCARE-I+ 8-sessionBehavioural
The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021. In addition, PROCARE-I+ adds additional modules, which allow adolescents to be provided with tools to address the risk factors they present.
| Study group | Role | What they receive |
|---|---|---|
| PROCARE-I (UP-A for indicated purposes) | Experimental | To ensure cost-effectiveness, PROCARE-I intervention will be designed as a brief 8-session child-focused programme 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 indicated preventive intervention format focused on cost-effectiveness. Receives: Behavioral: Active control condition |
| PROCARE-I+ 8-session (for indicated purposes) | Experimental | PROCARE-I+ intervention will be designed as a brief 8-session with 4 additonal sessions (add-on modules) child-focused programme by adapting the core modules from UP-A. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness. Receives: Behavioral: PROCARE-I+ 8-session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 7 months after start of interventions
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 7 months after start of interventions
Resilience measure
This primary measure was intended to measure the resilience of adolescents through 10 items with 5 response options. Scores range from 0 to 40. The higher the score, the greater the resilience.
Measured: Baseline to 7 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 7 months after start of interventions
Absence of emotional disorders
The study's primary outcome was absence of any emotional disorders over the long-term measured by the ADIS-5-C/P
Measured: Baseline to 7 months after start of interventions
Secondary outcomes (3)
Economic evaluations
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.
Measured: Baseline to 7 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 7 months after start of interventions
Emotional regulation
The Difficulties in Emotion Regulation Scale (DERS). Scores range from 0 to 150. The higher the score, the greater the difficulties in emotional regulation.
Measured: Baseline to 7 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 posted5 Apr 2024
- Study start15 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Model description
- To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 139 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
- Luis Joaquín García-López, Ph. D., Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350760
- Sponsor's protocol ID
- UJA_PROCARE-I+
- Acronym
- PROCARE-I+
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Authors of secondary analyses using shared data will attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They will also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses will explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data will deserve substantial credit for their efforts. Those using data collected by others will seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data will be recognized.
Publications
Ehrenreich-May, J.; & Kennedy, S.M. (2022). Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales en niños y adolescentes: Manual del terapeuta. Ediciones Pirámide.
Vivas-Fernandez M, Garcia-Lopez LJ, Piqueras JA, Muela-Martinez JA, Canals-Sans J, Espinosa-Fernandez L, Jimenez-Vazquez D, Diaz-Castela MDM, Morales-Hidalgo P, Rivera M, Ehrenreich-May J. Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders. Child Adolesc Psychiatry Ment Health. 2023 Jan 12;17(1):7. doi: 10.1186/s13034-022-00550-2.
PubMed 36635735
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)
- ClinicalTrials.gov ID
- NCT06350760
- Acronym / sponsor ID
- PROCARE-I+ / UJA_PROCARE-I+
- Keywords
- transdiagnostic, emotional disorders, anxiety, depression, adolescents, child and youth population, indicated prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 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
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Apr 2024 (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.
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty.
Detailed description
The general objetive of PROCARE-I+ is to implement and evaluate an indicated 8-session preventive group intervention with add-on modules for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The 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 indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program.
METHODOLOGY: In order to achieve this objetive, PROCARE-I+ working plan will be divided into 3 steps. Firstly, in order to identify adolescents at high 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, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Then, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. 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 PROCARE-I with add-on modules.
IMPACT: The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.
| Arm | Type | Receives |
|---|---|---|
| PROCARE-I (UP-A for indicated purposes) | Experimental | Behavioral: Active control conditionTo ensure cost-effectiveness, PROCARE-I intervention will be designed as a brief 8-session child-focused programme 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 indicated preventive intervention format focused on cost-effectiveness. |
| PROCARE-I+ 8-session (for indicated purposes) | Experimental | Behavioral: PROCARE-I+ 8-sessionPROCARE-I+ intervention will be designed as a brief 8-session with 4 additonal sessions (add-on modules) child-focused programme by adapting the core modules from UP-A. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- written informed consent from adolescent and legal guardian
- able to attend prevention modules on his/her own
- language competence
- Strengths and Difficulties Questionnaire ""probable diagnoses"
- score above cut-off for Revised Child Anxiety and Depression Scale-30
Key exclusion criteria (7 listed)
- in- or outpatient
- concomitant psychological/psychiatric treatment
- acute suicidality
- general medical contraindications that hamper attendance to prevention modules
- have been diagnosed with a neurodevelopmental disorder
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 |
|---|---|---|
| Active control conditionThe active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021. | Behavioural | PROCARE-I (UP-A for indicated purposes) |
| PROCARE-I+ 8-sessionThe active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021. In addition, PROCARE-I+ adds additional modules, which allow adolescents to be provided with tools to address the risk factors they present. | Behavioural | PROCARE-I+ 8-session (for indicated purposes) |
Primary outcome
Self-reported anxiety and mood symptomatology
Time frame: Baseline to 7 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
Factors associated with adolescents' mental health
Time frame: Baseline to 7 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 measure
Time frame: Baseline to 7 months after start of interventions
This primary measure was intended to measure the resilience of adolescents through 10 items with 5 response options. Scores range from 0 to 40. The higher the score, the greater the resilience.
Health-related quality of life
Time frame: Baseline to 7 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.
Absence of emotional disorders
Time frame: Baseline to 7 months after start of interventions
The study's primary outcome was absence of any emotional disorders over the long-term measured by the ADIS-5-C/P
3 secondary outcomes
Economic evaluations
Time frame: Baseline to 7 months after start of interventions
Psychological flexibility
Time frame: Baseline to 7 months after start of interventions
Emotional regulation
Time frame: Baseline to 7 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 1 May 2026.
- BackgroundEhrenreich-May, J.; & Kennedy, S.M. (2022). Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales en niños y adolescentes: Manual del terapeuta. Ediciones Pirámide.
- Background: PubMed 36635735Vivas-Fernandez M, Garcia-Lopez LJ, Piqueras JA, Muela-Martinez JA, Canals-Sans J, Espinosa-Fernandez L, Jimenez-Vazquez D, Diaz-Castela MDM, Morales-Hidalgo P, Rivera M, Ehrenreich-May J. Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders. Child Adolesc Psychiatry Ment Health. 2023 Jan 12;17(1):7. doi: 10.1186/s13034-022-00550-2.
- Individual participant dataSharing planned: Yes. Authors of secondary analyses using shared data will attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They will also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses will explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data will deserve substantial credit for their efforts. Those using data collected by others will seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data will be recognized.
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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.
Luis Joaquín García-López, Ph. D. principal investigator
University of Jaén
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-I+ 8-session 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 7 inclusion and 7 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 1 May 2026. 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?
Self-reported anxiety and mood symptomatology (time frame: Baseline to 7 months after start of interventions). The study lists 5 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 NCT06350760, which also lists 2 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 1 May 2026.