Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules

NCT ID: NCT06350760

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-12-31

Brief 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 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.

Conditions

Anxiety Disorders and Symptoms; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active control condition

Intervention Type: BEHAVIORAL

The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.

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.

Group Type: EXPERIMENTAL

PROCARE-I+ 8-session

Intervention Type: BEHAVIORAL

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.

Interventions

Active control condition

The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.

Intervention Type: BEHAVIORAL

PROCARE-I+ 8-session

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.

Intervention Type: BEHAVIORAL

Eligibility 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 ""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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

LuisJoaquin Garcia-Lopez

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Joaquín García-López, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Jaén

Locations

Universidad Miguel Hernández

Elche, Alicante, Spain

Site Status: RECRUITING

University of Jaén

Jaén, Jaen, Spain

Site Status: RECRUITING

Universitat Rovira i Virgili

Tarragona, Tarragona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

LuisJoaquín J García-López, Ph.D.

Role: CONTACT

ljgarcia@ujaen.es

953213412

Laura Zafra-Palomino, Ph.D.stud

Role: CONTACT

lzpalomi@ujaen.es

953213412

Facility Contacts

José Antonio Piqueras, Ph. D.

Role: primary

jpiqueras@umh.es

966658343

Luis Joaquín García-López, Ph. D.

Role: primary

ljgarcia@ujaen.es

953213412

Josefa Canals, M.D.

Role: primary

josefa.canals@urv.cat

977257895

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 36635735 (View on PubMed)

Other Identifiers

UJA_PROCARE-I+

Identifier Type: -

Identifier Source: org_study_id