Skip to main content
OpenTrials
Completed

NCT Number: NCT06350760

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorders and Symptoms Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Miguel Hernández, Elche, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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+ 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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Collaborators

  • Universidad Miguel Hernandez de Elche
  • University Rovira i Virgili
  • University of Miami

Registry information

Official study title

Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)

Acronym: PROCARE-I+

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.