Clinical trial NCT07021001: Promotion of Mental Health in Adolescents: A School-Based Preventive Version of the Unified Protocol (UP-A Kind)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery Intervention
Keywords: Mental Well-being
Unified Protocol
Adolescents
Transdiagnostic Processes
Emotion Regulation
Universal prevention
School
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: EPIS Association - Entrepreneurs for Social Inclusion
name: Z Zurich Foundation
name: Foundation for Science and Technology, Portugal
First posted: 2025-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is longitudinal research. The Cluster Randomized Control Trial include a Control Group (N=150) and an Experimental Group (N=150).
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Frequent 7º, 8º or 9º grade
* Providing written informed assent (the adolescent and the legal tutor)
* Being able to understand, write and read Portuguese

Exclusion Criteria:

* No exclusion criteria because of being a universal prevention study

Primary outcomes:
measure: Socio-Demographic Information Questionnaire
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Mental Health Continuum-Short Form (Keyes et al., 2008)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Kidscreen-10 (Portuguese version: Matos et al., 2012)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Overall Depression Severity and Impairment Scale (ODSIS) (Bentley, Gallagher, Carl, Barlow, 2014)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: School Connectedness Scale (SCS) (Furlong and O'Brennan, 2011)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
Secondary outcomes:
measure: Social Emotional Abilities Survey (UNICEF, 2023)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: The Multidimensional Emotional Disorder Inventory (MEDI) (Rosellini & Brown, 2019)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Difficulties in Emotion Regulation Scale Short Form (DERS-SF) (Portuguese version: Moreira et al., 2020)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Distress Tolerance Scale (DTS) (Tonarely & Ehrenreich-May, 2020)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Child and Adolescent Mindfulness Measure (CAMM) (Portuguese version: Cunha et al., 2013)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Self-Compassion Scale (SCS) (Portuguese version: Cunha et al., 2016)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
measure: Social Safeness and Pleasure Scale (SSPS-A) (Gilbert et al., 2009)
timeFrame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Study officials:
References: