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

University of Coimbra

Status: Enrolling

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

Treatments: 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).

Study type: Interventional

Funder types: Other

Identifiers

NCT07021001

2022.154441.BD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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).

Treatment:

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 group

Description:

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.