Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Coimbra, Portugal
Location status: Recruiting
NCT Number: NCT07021001
The goal of this clinical trial is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders for Adolescents (UP-A; Ehrenreich-May et al., 2018) as a universal school-based preventive intervention (UP-A Kind) in adolescents aged 11-18. This intervention aims to prevent emotional symptoms and improve adolescents' mental well-being in school setting, assessing changes in transdiagnostic processes. Researchers will compare an experimental group and a control group. Participants will participate in eight weekly sessions and will be assessed at 4 time points (pre- and post-treatment and 3-, 6- and 12-month follow-up). Control group participants will receive no intervention and will be assessed at the same time points.
Interested in participating?
Request Info11 year–18 year
All sexes
Interventional
Not applicable
Coimbra, Portugal
Location status: Recruiting
Emotional disorders are highly prevalent during adolescence, and significantly impact the development and well-being of adolescents. The World Health Organization defines preventive interventions and promotion of adolescent mental health as a priority. Nevertheless, many adolescents lack access to psychological interventions, leading to short, medium, and long-term impacts. The school setting is a privileged context for the implementation of universal preventive interventions as it offers accessibility to all adolescents. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018), a transdiagnostic intervention, has demonstrated effectiveness in reducing anxiety and depressive symptoms and improving quality of life in this population. Preventive transdiagnostic interventions may have better results in the long term. The main goal is to assess the efficacy of UP-A as a preventive intervention. The goal is prevent emotional symptoms and improve mental well-being, assessing changes in transdiagnostic factors, including cognitive flexibility, mindfulness, and distress tolerance. Participants are adolescents aged 11-18 that frequent 7-9 grade. The intervention will be delivered by clinical psychologists. The design is a cluster randomized controlled trial with two groups: control group and experimental group. Pre- and post-intervention, and follow-up at 3, 6 and 12 months will be carried out.
All procedures were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra and the School Boards authorized the data collection protocol to be implemented in school contexts. Informed consent from adolescents and their parents/legal guardians will be required. Adolescents and their parents/legal guardians will be informed that the participation is voluntary, confidential and that they can decline to participate at any time without any consequence.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The UP-A Kind is a school-based universal prevention intervention that aims to promote adaptive emotion regulations strategies, enhance mental well-being and prevent emotional disorders with the following contents: motivating to take care of mental well-being, psychoeducation about emotions, awareness of physical sensations, cognitive lexibility, behavioral experiences, recognizing warning signs, and promoting a compassionate attitude towards the self and others.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure Positive Mental Health.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure quality of life.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
ODSIS was used to measure Depression and was translate and adapt to Portuguese for this study.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
OASIS was used to measure Anxiety and was translate and adapt to Portuguese for this study.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure School connectedness and was adapted and translated to Portuguese for this study.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was adapted and translated to Portuguese for this study.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure transdiagnostic dimensions of Emotional disorders.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure emotion regulation difficulties.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
This measure is an adaptation of an adult measure of emotional avoidance (Fairholme, Ehrenreich-May, Ellard, Boisseau, Farchione, Barlow, 2008) and was adapted and translated to Portuguese for this study.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure distress tolerance.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure Mindfulness.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure self-compassion.
Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
The scale was used to measure Social Safeness.
Contact information is provided by the study sponsor or research team.
University of Coimbra
Other
Prevention and Promotion of Mental Well-being in Adolescents: Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders as a School-based Universal Prevention Program (UP-A Kind) Through a Cluster Randomized Controlled-trial
Acronym: UP-A Kind
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