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NCT Number: NCT07021001

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

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.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Location contact

Daniel Rijo, PhD

CONTACT

[email protected]

+351 239 247 410

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Socio-Demographic Information Questionnaire

    Time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months

  2. Mental Health Continuum-Short Form (Keyes et al., 2008)

    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.

  3. Kidscreen-10 (Portuguese version: Matos et al., 2012)

    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.

  4. Overall Depression Severity and Impairment Scale (ODSIS) (Bentley, Gallagher, Carl, Barlow, 2014)

    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.

  5. Overall Anxiety Severity and Impairment Scale (OASIS) (Norman, Cissell, Means-Christensen, & Stein, 2006)

    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.

  6. School Connectedness Scale (SCS) (Furlong and O'Brennan, 2011)

    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.

Secondary outcomes

  1. Social Emotional Abilities Survey (UNICEF, 2023)

    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.

  2. The Multidimensional Emotional Disorder Inventory (MEDI) (Rosellini & Brown, 2019)

    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.

  3. Difficulties in Emotion Regulation Scale Short Form (DERS-SF) (Portuguese version: Moreira et al., 2020)

    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.

  4. Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016)

    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.

  5. Distress Tolerance Scale (DTS) (Tonarely & Ehrenreich-May, 2020)

    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.

  6. Child and Adolescent Mindfulness Measure (CAMM) (Portuguese version: Cunha et al., 2013)

    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.

  7. Self-Compassion Scale (SCS) (Portuguese version: Cunha et al., 2016)

    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.

  8. Social Safeness and Pleasure Scale (SSPS-A) (Gilbert et al., 2009)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Inês Maçãs-Carvalho, MSc

CONTACT

[email protected]

+351 239 247 410

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • EPIS Association - Entrepreneurs for Social Inclusion
  • Foundation for Science and Technology, Portugal
  • Z Zurich Foundation

Registry information

Official study 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

Acronym: UP-A Kind

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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