The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery InterventionUP-A KindNCT07021001
Promotion of Mental Health in Adolescents: A School-Based Preventive Version of the Unified Protocol (UP-A Kind)
A study testing UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind). in people with The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery Intervention, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery Intervention
- What is being tested?
- UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Frequent 7º, 8º or 9º grade
- Providing written informed assent (the adolescent and the legal tutor)
- Being able to understand, write and read Portuguese
Who cannot join
- No exclusion criteria because of being a universal prevention study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Coimbra
Daniel Rijo, PhD, +351 239 247 410, drijo@fpce.uc.pt
About this study
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
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.
Read the 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.
- Being tested
- UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind).
- Keywords
- Mental Well-being, Unified Protocol, Adolescents, Transdiagnostic Processes, Emotion Regulation, Universal prevention, School
- Medical subject headings
- Psychological Well-Being, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind).Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind). |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-Demographic Information Questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
Secondary outcomes (8)
Social Emotional Abilities Survey (UNICEF, 2023)
The scale was adapted and translated to Portuguese for this study.
Measured: 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)
The scale was used to measure transdiagnostic dimensions of Emotional disorders.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is longitudinal research. The Cluster Randomized Control Trial include a Control Group (N=150) and an Experimental Group (N=150).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- EPIS Association - Entrepreneurs for Social Inclusion, Z Zurich Foundation, Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Inês Maçãs de Carvalho, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021001
- Sponsor's protocol ID
- 2022.154441.BD
- Acronym
- UP-A Kind
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07021001
- Acronym / sponsor ID
- UP-A Kind / 2022.154441.BD
- Keywords
- Mental Well-being, Unified Protocol, Adolescents, Transdiagnostic Processes, Emotion Regulation, Universal prevention, School
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- EPIS Association - Entrepreneurs for Social Inclusion, Z Zurich Foundation, Foundation for Science and Technology, Portugal
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is longitudinal research. The Cluster Randomized Control Trial include a Control Group (N=150) and an Experimental Group (N=150).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind).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). |
| 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Frequent 7º, 8º or 9º grade
- Providing written informed assent (the adolescent and the legal tutor)
- Being able to understand, write and read Portuguese
Key exclusion criteria (1 listed)
- No exclusion criteria because of being a universal prevention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind).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. | Behavioural | Experimental Group |
Primary outcome
Socio-Demographic Information Questionnaire
Time frame: 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)
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.
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.
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.
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.
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.
8 secondary outcomes
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 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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UP-A, a cognitive-behavioral structured group intervention, was adapted as a universal preventive intervention to be delivered in school settings (UP-A Kind). in people with The Focus is the Prevention and Promotion of Mental Well-being and is a Universal Delivery Intervention, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inês Maçãs-Carvalho, MSc (+351 239 247 410, inescarvalho.psicologia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-Demographic Information Questionnaire (time frame: Baseline, Week 8, Follow-Up 3 Months, Follow-Up 6 Months and Follow-Up 12 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.