- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350760
Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules (PROCARE-I+)
Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LuisJoaquín J García-López, Ph.D.
- Phone Number: 953213412
- Email: ljgarcia@ujaen.es
Study Contact Backup
- Name: Laura Zafra-Palomino, Ph.D.stud
- Phone Number: 953213412
- Email: lzpalomi@ujaen.es
Study Locations
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-
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Tarragona, Spain, 43003
- Recruiting
- Universitat Rovira i Virgili
-
Contact:
- Josefa Canals, M.D.
- Phone Number: 977257895
- Email: josefa.canals@urv.cat
-
Sub-Investigator:
- Josefa Canals, M.D.
-
-
Alicante
-
Elche, Alicante, Spain, 03202
- Recruiting
- Universidad Miguel Hernández
-
Contact:
- José Antonio Piqueras, Ph. D.
- Phone Number: 966658343
- Email: jpiqueras@umh.es
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Sub-Investigator:
- José Antonio Piqueras, Ph. D.
-
-
Jaen
-
Jaén, Jaen, Spain, 23071
- Recruiting
- University of Jaén
-
Contact:
- Luis Joaquín García-López, Ph. D.
- Phone Number: 953213412
- Email: ljgarcia@ujaen.es
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Principal Investigator:
- Luis Joaquín García-López, Ph. D.
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Principal Investigator:
- José Antonio Muela-Martínez, Ph. D.
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Principal Investigator:
- Lourdes Espinosa-Fernández, Ph. D.
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Principal Investigator:
- Laura Zafra-Palomino, Ph. D. stud
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Principal Investigator:
- David Jiménez-Vázquez, Ph. D. stud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 ""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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROCARE-I (UP-A for indicated purposes)
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.
|
The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.
|
Experimental: PROCARE-I+ 8-session (for indicated purposes)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to 7 months after start of interventions
|
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.
|
Baseline to 7 months after start of interventions
|
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
|
Baseline to 7 months after start of interventions
|
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.
|
Baseline to 7 months after start of interventions
|
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.
|
Baseline to 7 months after start of interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Economic evaluations
Time Frame: Baseline to 7 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.
|
Baseline to 7 months after start of interventions
|
Psychological flexibility
Time Frame: Baseline to 7 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. |
Baseline to 7 months after start of interventions
|
Emotional regulation
Time Frame: Baseline to 7 months after start of interventions
|
The Difficulties in Emotion Regulation Scale (DERS).
Scores range from 0 to 150.
The higher the score, the greater the difficulties in emotional regulation.
|
Baseline to 7 months after start of interventions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bullying
Time Frame: Baseline to 7 months after start of interventions
|
Cyberbullying. peer bullying screening.
Scores range from 0 to 40.
The higher the score, the greater the role played in bullying (aggressor, victim, observer).
|
Baseline to 7 months after start of interventions
|
Expressed Emotion
Time Frame: Baseline to 7 months after start of interventions
|
Expressed Emotion Evaluation Questionnaire.
The scores range from 1 to 7. The higher the score, the greater the difficulties in the family communication style.
|
Baseline to 7 months after start of interventions
|
Ecoanxiety
Time Frame: Baseline to 7 months after start of interventions
|
Climate Anxiety Scale.
Scores range from 13 to 52.
The higher the score, the greater the climate anxiety.
|
Baseline to 7 months after start of interventions
|
Exam anxiety
Time Frame: Baseline to 7 months after start of interventions
|
Test anxiety questionnaire adapted for ESO and Baccalaureate.
Scores range from 35 to 140.
The higher the score, the greater the anxiety before the exams.
|
Baseline to 7 months after start of interventions
|
Videogames addiction
Time Frame: Baseline to 7 months after start of interventions
|
Game Addiction Scale for Adolescents (GASA).
Scores range from 0 to 28.
The higher the score, the greater the risk of video game addiction.
|
Baseline to 7 months after start of interventions
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Smartphone addiction
Time Frame: Baseline to 7 months after start of interventions
|
Smartphone Addiction Scale - Short Version (SAS-SV).
Scores range from 10 to 70.
The higher the score, the greater the risk of smartphone addiction.
|
Baseline to 7 months after start of interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis Joaquín García-López, Ph. D., University of Jaén
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJA_PROCARE-I+
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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