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

Depressive Symptoms Clinical Trial

— PROCARE-I+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350760
• Other study ID #: UJA_PROCARE-I+
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Jaén
• Contact: LuisJoaquín J García-López, Ph.D.
• Phone: 953213412
• Email: ljgarcia[@]ujaen.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Depression
• Depressive Symptoms

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernández	Elche	Alicante
Spain	University of Jaén	Jaén	Jaen
Spain	Universitat Rovira i Virgili	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
University of Jaén	Universidad Miguel Hernandez de Elche, University of Miami, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bullying	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
Other	Expressed Emotion	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
Other	Ecoanxiety	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
Other	Exam anxiety	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
Other	Videogames addiction	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
Other	Smartphone addiction	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Economic evaluations	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
Secondary	Psychological flexibility	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
Secondary	Emotional regulation	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