Promotion of Mental Health in Adolescents: A School-Based Preventive Version of the Unified Protocol (UP-A Kind)

Not Applicable

Recruiting

• Conditions: The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery Intervention

• Registration Number: NCT07021001
• Lead Sponsor: University of Coimbra

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.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	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.
Kidscreen-10 (Portuguese version: Matos et al., 2012)	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.
Overall Depression Severity and Impairment Scale (ODSIS) (Bentley, Gallagher, Carl, Barlow, 2014)	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.
Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006)	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.
School Connectedness Scale (SCS) (Furlong and O'Brennan, 2011)	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.

Secondary Outcome Measures

Name	Time	Method
Social Emotional Abilities Survey (UNICEF, 2023)	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.
The Multidimensional Emotional Disorder Inventory (MEDI) (Rosellini & Brown, 2019)	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.
Difficulties in Emotion Regulation Scale Short Form (DERS-SF) (Portuguese version: Moreira et al., 2020)	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.
Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016)	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.
Distress Tolerance Scale (DTS) (Tonarely & Ehrenreich-May, 2020)	Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months	The scale was used to measure distress tolerance.
Child and Adolescent Mindfulness Measure (CAMM) (Portuguese version: Cunha et al., 2013)	Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months	The scale was used to measure Mindfulness.
Self-Compassion Scale (SCS) (Portuguese version: Cunha et al., 2016)	Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months	The scale was used to measure self-compassion.
Social Safeness and Pleasure Scale (SSPS-A) (Gilbert et al., 2009)	Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months	The scale was used to measure Social Safeness.

Trial Locations

Locations (1)

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra; 🇵🇹 Coimbra, Portugal