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Completed

NCT Number: NCT03123991

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UP-A adapted as a preventive intervention

Behavioral

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.

Same than experimental group (EG), after EG finishes

Behavioral

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 outcomes

  1. Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.

    Time frame: Up to 3 months

    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.

  2. 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.

    Time frame: Up to 3 months

    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.

  3. 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.

    Time frame: Up to 3 months

    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 outcomes

  1. Strenghts and Difficulties Questionnaire (SDQ) (Goodman, 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

    The Spanish version by García and colleagues was used (García et al., 2000).

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

    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

    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).

  3. Childhood Anxiety Sensitivity Index (CASI) (Silverman, Fleisig, Rabian, & Peterson, 1991).

    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

    The Spanish version by Sandín and Chorot was applied (Sandín & Chorot, 1997).

  4. Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) (Kennedy & Ehrenreich-May, 2016).

    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

    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.

  5. Depression and Anxiety Interference Scale for children [Escala de Interferencia de Depresión y Ansiedad en Niños] (EIDAN) (García-Escalera, Sandín, Chorot, & Valiente, 2017).

    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

    This scale measuring Depression and Anxiety Interference was created for this study.

  6. Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)

    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

    The Spanish adaptation by Chorot y Navas (1995; en Sandín, 2008) was used.

  7. Satisfacion With Life Scale for Children (SWLS-C) (Sandín, Chorot, & Valiente, 2015).

    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

    This measure is an adaptation for children and adolescents of an adult measure of satisfaction with life (SWLS) (Diener, Emmons, Larsen, & Griffin, 1985).

  8. Kidscreen-10 (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

    The Spanish official version by the KIDSCREEN Group was used to measure quality of life (KIDSCREEN Group, 2006)

  9. 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

  10. General Indiscipline Scale [Escala de Indisciplina General] (IG)

    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

    Adapted from Martín and colleagues' questionnaire (Martín, Pros, Busquets, & Muntada, 2012)

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Educación a Distancia

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain
  • Spanish Ministry of Education, Culture and Sport

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2017
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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