NCT03123991

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

March 16, 2017

Last Update Submit

November 28, 2017

Conditions

AnxietyDepression

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 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

  • Children Positive and Negative Affect Schedule [Escalas PANAS para niños] (PANASN) (Sandín, 2003).

    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).

    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).

    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).

    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

  • +7 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Wait-list Control Group

OTHER

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

Interventions

UP-A adapted as a preventive interventionBEHAVIORAL

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.

Experimental Group
Same than experimental group (EG), after EG finishesBEHAVIORAL

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.

Wait-list Control Group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32402261DERIVED

  • 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.

    PMID: 28827212DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Bonifacio Sandín, PhD

    Universidad Nacional de Educación a Distancia (UNED)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

April 21, 2017

Study Start

October 10, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11