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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UP-A adapted as a preventive intervention
Same than experimental group (EG), after EG finishes
Sponsored by
Universidad Nacional de Educación a Distancia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental Group

    Wait-list Control Group

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 1997).
    The Spanish version by García and colleagues was used (García et al., 2000).
    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).
    Childhood Anxiety Sensitivity Index (CASI) (Silverman, Fleisig, Rabian, & Peterson, 1991).
    The Spanish version by Sandín and Chorot was applied (Sandín & Chorot, 1997).
    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.
    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.
    Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)
    The Spanish adaptation by Chorot y Navas (1995; en Sandín, 2008) was used.
    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).
    Kidscreen-10 (KIDSCREEN Group, 2006)
    The Spanish official version by the KIDSCREEN Group was used to measure quality of life (KIDSCREEN Group, 2006)
    Schoool Adjustment Brief Scale [Escala Breve de Ajuste escolar] (EBAE-10) (Moral, Sánchez-Sosa, & Villarreal, 2010).
    General Indiscipline Scale [Escala de Indisciplina General] (IG)
    Adapted from Martín and colleagues' questionnaire (Martín, Pros, Busquets, & Muntada, 2012)
    Socio-Demographic Information Questionnaire
    End of Program Questionnaire

    Full Information

    First Posted
    March 16, 2017
    Last Updated
    November 28, 2017
    Sponsor
    Universidad Nacional de Educación a Distancia
    Collaborators
    Spanish Ministry of Education, Culture and Sport, Ministerio de Economía y Competitividad, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03123991
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2016 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Nacional de Educación a Distancia
    Collaborators
    Spanish Ministry of Education, Culture and Sport, Ministerio de Economía y Competitividad, Spain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    157 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Wait-list Control Group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    UP-A adapted as a preventive intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Same than experimental group (EG), after EG finishes
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.
    Description
    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.
    Time Frame
    Up to 3 months
    Title
    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.
    Description
    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.
    Time Frame
    Up to 3 months
    Title
    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.
    Description
    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.
    Time Frame
    Up to 3 months
    Secondary Outcome Measure Information:
    Title
    Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 1997).
    Description
    The Spanish version by García and colleagues was used (García et al., 2000).
    Time Frame
    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
    Title
    Children Positive and Negative Affect Schedule [Escalas PANAS para niños] (PANASN) (Sandín, 2003).
    Description
    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).
    Time Frame
    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
    Title
    Childhood Anxiety Sensitivity Index (CASI) (Silverman, Fleisig, Rabian, & Peterson, 1991).
    Description
    The Spanish version by Sandín and Chorot was applied (Sandín & Chorot, 1997).
    Time Frame
    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
    Title
    Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016).
    Description
    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.
    Time Frame
    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
    Title
    Depression and Anxiety Interference Scale for children [Escala de Interferencia de Depresión y Ansiedad en Niños] (EIDAN) (García-Escalera, Sandín, Chorot, & Valiente, 2017).
    Description
    This scale measuring Depression and Anxiety Interference was created for this study.
    Time Frame
    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
    Title
    Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)
    Description
    The Spanish adaptation by Chorot y Navas (1995; en Sandín, 2008) was used.
    Time Frame
    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
    Title
    Satisfacion With Life Scale for Children (SWLS-C) (Sandín, Chorot, & Valiente, 2015).
    Description
    This measure is an adaptation for children and adolescents of an adult measure of satisfaction with life (SWLS) (Diener, Emmons, Larsen, & Griffin, 1985).
    Time Frame
    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
    Title
    Kidscreen-10 (KIDSCREEN Group, 2006)
    Description
    The Spanish official version by the KIDSCREEN Group was used to measure quality of life (KIDSCREEN Group, 2006)
    Time Frame
    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
    Title
    Schoool Adjustment Brief Scale [Escala Breve de Ajuste escolar] (EBAE-10) (Moral, Sánchez-Sosa, & Villarreal, 2010).
    Time Frame
    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
    Title
    General Indiscipline Scale [Escala de Indisciplina General] (IG)
    Description
    Adapted from Martín and colleagues' questionnaire (Martín, Pros, Busquets, & Muntada, 2012)
    Time Frame
    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
    Title
    Socio-Demographic Information Questionnaire
    Time Frame
    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
    Title
    End of Program Questionnaire
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bonifacio Sandín, PhD
    Organizational Affiliation
    Universidad Nacional de Educación a Distancia (UNED)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32402261
    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.
    Results Reference
    derived
    PubMed Identifier
    28827212
    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.
    Results Reference
    derived

    Learn more about this trial

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

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