Clinical trial NCT03123991: Applying the Spanish Version of the UP-A as a Universal School-based Anxiety and Depression Prevention Program
Official title: Applying the Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents as a Universal School-based Anxiety and Depression Prevention Program: a Cluster Randomized Controlled-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Spanish Ministry of Education, Culture and Sport
name: Ministerio de Economía y Competitividad, Spain
First posted: 2017-04-21
Enrollment: 157
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study proposes to extend transdiagnostic treatment research to adolescents by establishing initial pre to post-treatment and follow-up outcomes associated with the use of the Spanish Version of the Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May, Bilek, Buzzella, Kennedy, Mash, \& Bennett, 2016) as a universal school-based preventive intervention.

Detailed description: The study has the primary aim to examine whether a transdiagnostic CBT intervention adapted as a school-based universal preventive intervention and delivered by professionals is more effective than the usual school curriculum in: (1) reducing symptoms of anxiety and depression and (2) preventing high levels of anxiety and depression from developing in 13-18 years old adolescents.

The study has the following secondary aims: (1) Examine the reduction in negative affect, anxiety sensitivity, emotional avoidance and emotional symptoms' interference levels at post-treatment as compared to pre-treatment levels; (3) Examine the improvement in positive affect, self-esteem, satisfaction with life, quality of life, school adjustment, and general indiscipline at post-treatment as compared to pre-treatment levels; (4) Examine the moderating role of gender, age, social economic status, personality traits, conduct problems, hyperactivity/inattention, and peer problems on the effectiveness of the UP-A program; (5) Assess the moderating role of home practice, understanding of basic concepts of the program, number of sessions attended, practice of specific strategies and behavior during sessions (6) Examine if the effects at post-treatment are maintained at the 3 month follow up; (7) Assess the feasibility and acceptability of implementing UP-A in a group format and in a school setting.

Eligibility criteria: Inclusion Criteria:

* Providing written, informed consent (both the adolescent and at least one of the parents or legal tutors)
* Being able to understand, write and read Spanish

Exclusion Criteria:

* No other exclusion criteria because of being an universal prevention study

Primary outcomes:
measure: Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.
timeFrame: Up to 3 months
measure: Change in Depression Questionnaire for Children [Cuestionario de Depresión para Niños] (CDN) (Sandín, Chorot, & Valiente, 2016) at pre, post intervention and at 3 months follow-up.
timeFrame: Up to 3 months
measure: Change in Anxiety Scale for Children [Escala de Ansiedad para Niños] (EAN) (Sandín et al., 2016) at pre, post intervention and at 3 months follow-up.
timeFrame: Up to 3 months
Secondary outcomes:
measure: Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 1997).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Children Positive and Negative Affect Schedule [Escalas PANAS para niños] (PANASN) (Sandín, 2003).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Childhood Anxiety Sensitivity Index (CASI) (Silverman, Fleisig, Rabian, & Peterson, 1991).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Depression and Anxiety Interference Scale for children [Escala de Interferencia de Depresión y Ansiedad en Niños] (EIDAN) (García-Escalera, Sandín, Chorot, & Valiente, 2017).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Satisfacion With Life Scale for Children (SWLS-C) (Sandín, Chorot, & Valiente, 2015).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Kidscreen-10 (KIDSCREEN Group, 2006)
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Schoool Adjustment Brief Scale [Escala Breve de Ajuste escolar] (EBAE-10) (Moral, Sánchez-Sosa, & Villarreal, 2010).
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: General Indiscipline Scale [Escala de Indisciplina General] (IG)
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: Socio-Demographic Information Questionnaire
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
measure: End of Program Questionnaire
timeFrame: One week before and one week after after experimental group receives intervention; three months after experimental group finishes intervention and one week after wait-list control group finishes intervention
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Nacional de Educación a Distancia (UNED)
name: Bonifacio Sandín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14.
citation: Garcia-Escalera J, Valiente RM, Chorot P, Ehrenreich-May J, Kennedy SM, Sandin B. The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2017 Aug 21;6(8):e149. doi: 10.2196/resprot.7934.