Applying the Spanish Version of the UP-A as a Universal School-based Anxiety and Depression Prevention Program

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: UP-A adapted as a preventive intervention; Behavioral: Same than experimental group (EG), after EG finishes

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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; UP-A adapted as a preventive intervention. Specifically, the Spanish version of The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) adapted as a 9 sessions school-based preventive intervention. The intervention is delivered in nine weekly sessions (each session lasting around 55 minutes).	Behavioral: UP-A adapted as a preventive intervention; The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) adapted as a school-based anxiety and depression preventive intervention. The UP-A (Ehrenreich-May et al., 2016) is a transdiagnostic anxiety and depressive disorders treatment protocol that implement a set of core principles to address common factors underlying youth anxiety and depressive symptoms in an individual setting. Core modules of the UP-A include: (1) Building and Keeping Motivation; (2) Getting to Know Your Emotions and Behaviors; (3) Behavioral Activation; (4) Sensational Awareness; (5) Being Flexible In Your Thinking; (6) Awareness of Emotional Experiences; (7) Situational Emotion Exposures and (8) Keeping it Going - Maintaining Your Gains.
Other: Wait-list Control Group; Same than experimental group (EG), after EG finishes. Specifically, classes in waitlist condition will be offered the same intervention than experimental group after EG finishes the three months follow-up.Before that, waitlist means that the classess work as usual with issues of mental health.	Behavioral: Same than experimental group (EG), after EG finishes; The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) adapted as a school-based anxiety and depression preventive intervention. The UP-A (Ehrenreich-May et al., 2016) is a transdiagnostic anxiety and depressive disorders treatment protocol that implement a set of core principles to address common factors underlying youth anxiety and depressive symptoms in an individual setting. Core modules of the UP-A include: (1) Building and Keeping Motivation; (2) Getting to Know Your Emotions and Behaviors; (3) Behavioral Activation; (4) Sensational Awareness; (5) Being Flexible In Your Thinking; (6) Awareness of Emotional Experiences; (7) Situational Emotion Exposures and (8) Keeping it Going - Maintaining Your Gains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.	RCADS-30 is a widely-used questionnaire of self-reported anxiety and depressive symptoms in children and adolescents. The scale is comprised of six subscales derived from DSM-IV criteria: social phobia (SOC), generalized anxiety disorder (GAD), obsessive-compulsive disorder (OCD), panic disorder (PD), separation anxiety disorder (SAD), and major depressive disorder (MDD). All subscales except for the MDD can be summed to creat a Total Anxiety Disorder Symptoms Score. Each item is scored from 0 (= Never) to 3 (= Always), with higher scores representing more severe symptoms.	Up to 3 months
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.	The CDN is a 16-item self-report questionnaire designed to assess symptoms of DSM-IV major depressive disorder and dysthymic disorder in children and adolescents. In this study, the two items targeting suicidal ideation were not included because of indications from the school principal and school counseler implicated in the study. The items are rated on a 3-point scale of frequency corresponding to Never or almost never (=0), Sometimes (=1), and Very often (2). The sum of all items provides an overall score with higher scores indicated more elevated depression symptoms.	Up to 3 months
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.	This 10- item questionnaire targeted to children and adolescents assesses anxiety symptoms during the last few weeks. Participants are instructed to respond to how frequently they have felt or experienced general anxiety symptoms on a four point, Likert-type scale, ranging from 0 (= Never or almost never) to 3 (= A lot of the times or almost always). The sum of all items provides an overall score with higher scores indicating more elevated anxiety symptoms.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 1997).	The Spanish version by García and colleagues was used (García et al., 2000).	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
Children Positive and Negative Affect Schedule [Escalas PANAS para niños] (PANASN) (Sandín, 2003).	This questionnaire is a downward version for children and adolescents aged 7-17 years of the Positive and Negative Affect Schedule for adults (Watson, Clark, & Tellegen, 1988).	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
Childhood Anxiety Sensitivity Index (CASI) (Silverman, Fleisig, Rabian, & Peterson, 1991).	The Spanish version by Sandín and Chorot was applied (Sandín & Chorot, 1997).	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
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). The scale was adapted and translated to Spanish for this study.	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
Depression and Anxiety Interference Scale for children [Escala de Interferencia de Depresión y Ansiedad en Niños] (EIDAN) (García-Escalera, Sandín, Chorot, & Valiente, 2017).	This scale measuring Depression and Anxiety Interference was created for this study.	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
Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)	The Spanish adaptation by Chorot y Navas (1995; en Sandín, 2008) was used.	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
Satisfacion With Life Scale for Children (SWLS-C) (Sandín, Chorot, & Valiente, 2015).	This measure is an adaptation for children and adolescents of an adult measure of satisfaction with life (SWLS) (Diener, Emmons, Larsen, & Griffin, 1985).	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
Kidscreen-10 (KIDSCREEN Group, 2006)	The Spanish official version by the KIDSCREEN Group was used to measure quality of life (KIDSCREEN Group, 2006)	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
Schoool Adjustment Brief Scale [Escala Breve de Ajuste escolar] (EBAE-10) (Moral, Sánchez-Sosa, & Villarreal, 2010).		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
General Indiscipline Scale [Escala de Indisciplina General] (IG)	Adapted from Martín and colleagues' questionnaire (Martín, Pros, Busquets, & Muntada, 2012)	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
Socio-Demographic Information Questionnaire		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
End of Program Questionnaire		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

Collaborators and Investigators

• Sponsor: Universidad Nacional de Educación a Distancia
• Collaborators: Ministerio de Economía y Competitividad, Spain; Spanish Ministry of Education, Culture and Sport
• Investigators: Principal Investigator: Bonifacio Sandín, PhD, Universidad Nacional de Educación a Distancia (UNED)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 13/03315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No