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

NCT06350760 | Completed DMC

• 1 other identifier: UJA_PROCARE-I+
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 3

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.

Conditions

Depressive Symptoms; Anxiety Disorders and Symptoms

Keywords

transdiagnostic; emotional disorders; anxiety; depression; adolescents; child and youth population; indicated prevention

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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.

  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

  Baseline to 7 months after start of interventions

Secondary Outcomes (3)

• Economic evaluations

  Baseline to 7 months after start of interventions

• Psychological flexibility

  Baseline to 7 months after start of interventions

• Emotional regulation

  Baseline to 7 months after start of interventions

Other Outcomes (6)

• Bullying

  Baseline to 7 months after start of interventions

• Expressed Emotion

  Baseline to 7 months after start of interventions

• Ecoanxiety

  Baseline to 7 months after start of interventions

Study Arms (2)

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.

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.

Behavioral: PROCARE-I+ 8-session

Interventions

Active control condition BEHAVIORAL

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

PROCARE-I (UP-A for indicated purposes)

PROCARE-I+ 8-session 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.

PROCARE-I+ 8-session (for indicated purposes)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jaén: lead
• Universidad Miguel Hernandez de Elche: collaborator
• University Rovira i Virgili: collaborator
• University of Miami: collaborator

Study Sites (3)

Universidad Miguel Hernández

Elche, Alicante, 03202, Spain

Location

University of Jaén

Jaén, Jaen, 23071, Spain

Location

Universitat Rovira i Virgili

Tarragona, Tarragona, 43003, Spain

Location

Related Publications (2)

• 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.

  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.

  PMID: 36635735 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Luis Joaquín García-López, Ph. D.

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 5, 2024
• Study Start: March 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From June 2024
• Access Criteria: upon request to authors

Locations

ES (3)