Clinical trial NCT06350760: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules
Official title: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems with Add-On Modules (PROCARE-I+)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depressive Symptoms
Keywords: transdiagnostic
emotional disorders
anxiety
depression
adolescents
child and youth population
indicated prevention
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: Universidad Miguel Hernandez de Elche
name: University Rovira i Virgili
name: University of Miami
First posted: 2024-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Self-reported anxiety and mood symptomatology
timeFrame: Baseline to 7 months after start of interventions
measure: Factors associated with adolescents' mental health
timeFrame: Baseline to 7 months after start of interventions
measure: Resilience measure
timeFrame: Baseline to 7 months after start of interventions
measure: Health-related quality of life
timeFrame: Baseline to 7 months after start of interventions
measure: Absence of emotional disorders
timeFrame: Baseline to 7 months after start of interventions
Secondary outcomes:
measure: Economic evaluations
timeFrame: Baseline to 7 months after start of interventions
measure: Psychological flexibility
timeFrame: Baseline to 7 months after start of interventions
measure: Emotional regulation
timeFrame: Baseline to 7 months after start of interventions
Other outcomes:
measure: Bullying
timeFrame: Baseline to 7 months after start of interventions
measure: Expressed Emotion
timeFrame: Baseline to 7 months after start of interventions
measure: Ecoanxiety
timeFrame: Baseline to 7 months after start of interventions
measure: Exam anxiety
timeFrame: Baseline to 7 months after start of interventions
measure: Videogames addiction
timeFrame: Baseline to 7 months after start of interventions
measure: Smartphone addiction
timeFrame: Baseline to 7 months after start of interventions
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernández
state: Alicante
city: Jaén
country: Spain
facility: University of Jaén
state: Jaen
city: Tarragona
country: Spain
facility: Universitat Rovira i Virgili
Study officials:
affiliation: University of Jaén
name: Luis Joaquín García-López, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.