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

NCT07021001 | Recruiting

• 1 other identifier: 2022.154441.BD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (8)

• Social Emotional Abilities Survey (UNICEF, 2023)

  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)

  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)

  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)

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

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

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

Study Arms (2)

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).

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.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Coimbra: lead
• EPIS Association - Entrepreneurs for Social Inclusion: collaborator
• Z Zurich Foundation: collaborator
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

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

Coimbra, Portugal

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Emotional Regulation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Self-Control; Social Behavior

Central Study Contacts

Inês Maçãs-Carvalho, MSc

CONTACT

+351 239 247 410; inescarvalho.psicologia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Baseline assessment occurs previously to allocation to experimental and control groups. Outcomes assessor is blind to participants' group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: This is longitudinal research. The Cluster Randomized Control Trial include a Control Group (N=150) and an Experimental Group (N=150).

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

PT (1)