Selective Prevention Transdiagnostic Intervention for At-risk Adolescents (PROCARE)
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|ClinicalTrials.gov Identifier: NCT04851366|
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders and Symptoms Depressive Symptoms||Behavioral: PROCARE+ (with add-on modules) Behavioral: PROCARE (UP-A for selective purposes) Behavioral: Active control condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||318 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Two interventions are evaluated in parallel against a active control group|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||A three-armed simple-blind RCT will be conducted.|
|Official Title:||Selective PRevention Through transdiagnOstiC Intervention for Adolescents at Risk of Emotional Disorders (PROCARE)|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: PROCARE+ (with add-on modules)
In addition to core UP-A preventive intervention, PROCARE will apply an innovative personalized medicine approach by adding specific modules according to the risk factor evidenced by adolescents. Different modules will be suited for the stratified groups in a more personalized format. Add-on young-focused modules would include, but not limited to social, parental, stress-related (including CoVid19 impact) risk factors, and health. Dosage (number of modules) will be included as covariate in all subsequent analyses.
Behavioral: PROCARE+ (with add-on modules)
The modules will mainly consist in therapy sessions to provide the adolescents with tools to confront risk situations such as communication skills, coping skills to manage stress, etc. The group will include education about discussing thoughts, feelings, and behaviour as parts of emotion, and emphasis on providing support around the specific risks factors detected.
Experimental: PROCARE (UP-A for selective purposes)
To ensure cost-effectiveness, PROCARE core intervention will be designed as a brief 8-session child-focused programme which aims to build resilience for adolescents 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 selective preventive intervention format focused on cost-effectiveness.
Behavioral: PROCARE (UP-A for selective purposes)
This core intervention is meant to respond to the heterogeneity inherent in emotional difficulties presentation by extinguishing distress associated with the presentation of heightened negative emotion in general and reduction or elimination of resultant emotionally-driven behaviours, including avoidance, escape, aggression, and controlling behaviours (e.g., reassurance seeking) that reinforce emotional distress intensity over time.
Active Comparator: Active control condition.
The active control condition will be based on the "U talk programme" developed by Prf. Jill Ehrenreich-May at University of Miami and colleagues. It follows a similar structure as the UP-A original programme and allows for two alternative compare conditions to PROCARE. The U Talk programme support-based group condition will be used as active control condition.
Behavioral: Active control condition
Psychoeducation about many different emotions, emphasis on discussing thoughts, feelings, and behavior as parts of emotion, and emphasis on providing support around generally distressing events.
- Self-reported anxiety and mood symptomatology [ Time Frame: Baseline to 12 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.
- Factors associated with adolescents' mental health [ Time Frame: Baseline to 12 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.
- Resilience [ Time Frame: Baseline to 12 months after start of interventions ]Self-reported resilience, as measured by Connor-Davidson Resilience Scale (CD-RISC). Total scores range from 0 to 100. Higher scores mean a better outcome.
- Health-related quality of life [ Time Frame: Baseline to 12 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.
- Economic evaluations [ Time Frame: Baseline to 12 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.
- Educational outcome [ Time Frame: Baseline to 12 months after start of interventions ]Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.
- Emotion regulation skills [ Time Frame: Baseline to 12 months after start of interventions ]Emotion regulation skills as assessed by Difficulties in Emotion Regulation Scale-36 (DERS-36). Total scores range from 36 to 180. Higher scores mean a worse outcome.
- Psychological flexibility [ Time Frame: Baseline to 12 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851366
|Contact: LuisJoaquin Garcia-Lopez, PhDemail@example.com|
|Contact: JoseAntonio Muela-Martinez, PhDfirstname.lastname@example.org|
|Universidad Miguel Hernandez||Recruiting|
|Elche, Alicante, Spain, 03202|
|Contact: Jose A Piqueras, PhD 966658343 email@example.com|
|Sub-Investigator: Jose A Piqueras, Ph.D.|
|Sub-Investigator: Maria Rivera-Riquelme, M.A.|
|University of Jaen||Recruiting|
|Jaén, Jaen, Spain, 23071|
|Contact: LuisJoaquin Garcia-Lopez, PhD 953213412 firstname.lastname@example.org|
|Principal Investigator: LuisJoaquin Garcia-Lopez, Ph.D.|
|Principal Investigator: Jose A Muela-Martinez, Ph.D.|
|Principal Investigator: Lourdes Espinosa-Fernandez, Ph.D.|
|Principal Investigator: Manuel Vivas-Fernandez, Ph.D. stud|
|Principal Investigator: Eva M Parras-Blanca, M.A.|
|Principal Investigator: David Jimenez-Vazquez, M.A.|
|Universitat Rovira i Virgili||Recruiting|
|Tarragona, Spain, 43003|
|Contact: Josefa Canals, M.D. 977257895 email@example.com|
|Sub-Investigator: Josefa Canals, M.D.|
|Sub-Investigator: Paula Morales-Hidalgo, Ph.D.|
|Principal Investigator:||LuisJoaquin Garcia-Lopez, PhD||University of Jaen|