Anxiety Disorders and Symptoms, Depressive Symptoms
Conditions
Keywords
transdiagnostic, emotional disorders, anxiety, depression, adolescents, child and youth population, indicated 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.
Interventions
BEHAVIORALActive control condition
The active control condition will be based on PROCARE protocol, which was put into practice in PROCARE-I, in 2021.
BEHAVIORALPROCARE-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.
Sponsors
University of Jaén
Universidad Miguel Hernandez de Elche
University Rovira i Virgili
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported anxiety and mood symptomatology | 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 |
| Factors associated with adolescents' mental health | 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. |
| Resilience measure | 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. |
| Health-related quality of life | 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. |
| Absence of emotional disorders | 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
| Measure | Time frame | Description |
|---|---|---|
| Economic evaluations | 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. |
| Psychological flexibility | 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. |
| Emotional regulation | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORLuis Joaquín García-López, Ph. D.
University of Jaén
Outcome results
None listed