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| Name | Class |
|---|---|
| EPIS Association - Entrepreneurs for Social Inclusion | UNKNOWN |
| Z Zurich Foundation | UNKNOWN |
| Foundation for Science and Technology, Portugal | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | UP-A Kind is a school based universal preventive intervention with 8 sessions adapted from the UP-A. Intervention is delivered in eight weekly sessions (each session lasting around 100 minutes). Participants pertaining to this group will be assessed at 4 different time points (pre- and post-treatment and at a 3-, 6- and 12- month follow-up). |
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| Control Group | No Intervention | Control group participants will receive no treatment and will be assessed at the same time points as participants from the Experimental group (pre- and pos-intervention, 3-, 6- and 12-month follow-up). Participants in Control group will be offered the possibility of participating in the UP-A Kind after the 12-month follow-up in a voluntary basis. Nevertheless, data from this delivery will not be included in the clinical trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind). | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-Demographic Information Questionnaire | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months | |
| Mental Health Continuum-Short Form (Keyes et al., 2008) | The scale was used to measure Positive Mental Health. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Kidscreen-10 (Portuguese version: Matos et al., 2012) | The scale was used to measure quality of life. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Overall Depression Severity and Impairment Scale (ODSIS) (Bentley, Gallagher, Carl, Barlow, 2014) | ODSIS was used to measure Depression and was translate and adapt to Portuguese for this study. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006) | OASIS was used to measure Anxiety and was translate and adapt to Portuguese for this study. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| School Connectedness Scale (SCS) (Furlong and O'Brennan, 2011) | The scale was used to measure School connectedness and was adapted and translated to Portuguese for this study. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Social Emotional Abilities Survey (UNICEF, 2023) | The scale was adapted and translated to Portuguese for this study. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| The Multidimensional Emotional Disorder Inventory (MEDI) (Rosellini & Brown, 2019) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inês Maçãs-Carvalho, MSc | Contact | +351 239 247 410 | inescarvalho.psicologia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra | Recruiting | Coimbra | Portugal |
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This is longitudinal research. The Cluster Randomized Control Trial include a Control Group (N=150) and an Experimental Group (N=150).
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Baseline assessment occurs previously to allocation to experimental and control groups. Outcomes assessor is blind to participants' group allocation.
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The scale was used to measure transdiagnostic dimensions of Emotional disorders. |
| Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Difficulties in Emotion Regulation Scale Short Form (DERS-SF) (Portuguese version: Moreira et al., 2020) | The scale was used to measure emotion regulation difficulties. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016) | 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. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Distress Tolerance Scale (DTS) (Tonarely & Ehrenreich-May, 2020) | The scale was used to measure distress tolerance. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Child and Adolescent Mindfulness Measure (CAMM) (Portuguese version: Cunha et al., 2013) | The scale was used to measure Mindfulness. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Self-Compassion Scale (SCS) (Portuguese version: Cunha et al., 2016) | The scale was used to measure self-compassion. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
| Social Safeness and Pleasure Scale (SSPS-A) (Gilbert et al., 2009) | The scale was used to measure Social Safeness. | Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
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