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

Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín, Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín

Abstract

Background: Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program.

Objective: The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting.

Methods: A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed.

Results: We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017.

Conclusions: We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers.

Trial registration: Clinicaltrials.gov NCT03123991; https://ichgcp.net/clinical-trials-registry/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR).

Keywords: adolescents; anxiety; cluster; depression; emotional disorders; randomized controlled trial; school intervention; transdiagnostic; unified protocol; universal prevention.

Conflict of interest statement

Conflicts of Interest: None declared.

©Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.08.2017.

Figures

Figure 1
Figure 1
CONSORT flow diagram.

References

    1. Fernández-Máximo A, Martínez-Arias R, Rodríguez-Sutil C. Prevalencia de trastornos psicológicos en niños y adolescentes, su relación con la edad y el género. Psicothema. 2000;12(4):525–532.
    1. Merikangas KR, He J, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A) J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980–9. doi: 10.1016/j.jaac.2010.05.017.
    1. Beecham J. Annual research review: child and adolescent mental health interventions: a review of progress in economic studies across different disorders. J Child Psychol Psychiatry. 2014 Jun;55(6):714–32. doi: 10.1111/jcpp.12216.
    1. Bodden DH, Dirksen CD, Bögels SM. Societal burden of clinically anxious youth referred for treatment: a cost-of-illness study. J Abnorm Child Psychol. 2008 May;36(4):487–97. doi: 10.1007/s10802-007-9194-4.
    1. Lewinsohn PM, Solomon A, Seeley JR, Zeiss A. Clinical implications of “subthreshold” depressive symptoms. J Abnorm Psychol. 2000 May;109(2):345–51.
    1. Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086–93. doi: 10.1097/00004583-200109000-00018.
    1. Essau CA. Frequency and patterns of mental health services utilization among adolescents with anxiety and depressive disorders. Depress Anxiety. 2005;22(3):130–7. doi: 10.1002/da.20115.
    1. Mrazek PJ, Haggerty RJ, editors. Reducing Risks for Mental Disorders: Frontiers for Preventive Intervention Research. Washington, DC: National Academy Press; 1994.
    1. Essau CA, Conradt J, Sasagawa S, Ollendick TH. Prevention of anxiety symptoms in children: results from a universal school-based trial. Behav Ther. 2012 Jun;43(2):450–64. doi: 10.1016/j.beth.2011.08.003.
    1. Dozois DJA, Seeds PM, Collins KA. Transdiagnostic approaches to the prevention of depression and anxiety. J Cogn Psychother. 2009;23(1):44–59.
    1. Axelson DA, Birmaher B. Relation between anxiety and depressive disorders in childhood and adolescence. Depress Anxiety. 2001;14(2):67–78.
    1. Joiner TE, Catanzaro SJ, Laurent J, Sandín B, Blalock JA. Modelo tripartito sobre el afecto positivo y negativo, la depresión y la ansiedad: Evidencia basada en la estructura de los síntomas y en diferencias sexuales. Rev Psicopatol Psicol Clin. 1996;1(1):27–34.
    1. Ehrenreich-May J, Bilek EL, Queen AH, Hernandez-Rodríguez J. A unified protocol for the group treatment of childhood anxiety and depression. Rev Psicopatol Psicol Clin. 2012;17(3):219–236.
    1. Sandín B, Chorot P, Valiente RM. Transdiagnóstico: Nueva frontera en psicología clínica. Rev Psicopatol Psicol Clin. 2012;17(3):185–203. doi: 10.5944/rppc.vol.17.num.3.2012.11839.
    1. McEvoy PM, Nathan P, Norton PJ. Efficacy of transdiagnostic treatments: a review of published outcome studies and future research directions. J Cogn Psychother. 2009 Feb 01;23(1):20–33. doi: 10.1891/0889-8391.23.1.20.
    1. Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a “transdiagnostic” theory and treatment. Behav Res Ther. 2003 May;41(5):509–28.
    1. Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen Lj, May J. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide (Treatments That Work) New York, NY: Oxford University Press, USA; 2010.
    1. Ehrenreich-May J, Bilek E, Buzzella B, Kennedy SM, Mash JA, Bennett SM, et al. The unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide [In Press] New York, NY: Oxford University Press; 2017.
    1. Bilek EL, Ehrenreich-May J. An open trial investigation of a transdiagnostic group treatment for children with anxiety and depressive symptoms. Behav Ther. 2012 Dec;43(4):887–97. doi: 10.1016/j.beth.2012.04.007.
    1. Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46–55. doi: 10.1016/j.janxdis.2016.10.006.
    1. García-Escalera J, Chorot P, Valiente RM, Reales JM, Sandín B. Efficacy of transdiagnostic cognitive-behavioral therapy for anxiety and depression in adults, children and adolescents: A meta-analysis. Rev Psicopatol Psicol Clin. 2016;21(3):147–175. doi: 10.5944/rppc.vol.21.num.3.2016.17811.
    1. Kendall P, Stark K, Martinsen K, Rodriguez K, Arora P. Group Leader Manual for Emotion: “coping Kids” Managing Anxiety and Depression. Ardmore, PA: Workbook Publishing; 2013.
    1. Essau CA, Ollendick TH. The Super Skills for Life Programme. London: University of Roehampton; 2013.
    1. Martinsen K, Kendall P, Stark K, Neumer S. Prevention of anxiety and depression in children: acceptability and feasibility of the transdiagnostic EMOTION program. Cogn Behav Pract. 2016 Feb;23(1):1–13. doi: 10.1016/j.cbpra.2014.06.005.
    1. La Greca AM, Ehrenreich-May J, Mufson L, Chan S. Preventing adolescent social anxiety and depression and reducing peer victimization: intervention development and open trial. Child Youth Care Forum. 2016 Dec;45(6):905–926. doi: 10.1007/s10566-016-9363-0.
    1. Ehrenreich-May J, Bilek EL. Universal prevention of anxiety and depression in a recreational camp setting: an initial open trial. Child Youth Care Forum. 2011 Dec;40(6):435–455. doi: 10.1007/s10566-011-9148-4.
    1. Ahlen J, Lenhard F, Ghaderi A. Universal prevention for anxiety and depressive symptoms in children: a meta-analysis of randomized and cluster-randomized trials. J Prim Prev. 2015 Dec;36(6):387–403. doi: 10.1007/s10935-015-0405-4.
    1. Campbell MK, Elbourne DR, Altman DG, CONSORT Group CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702–8. doi: 10.1136/bmj.328.7441.702.
    1. Calkins SD. Psychobiological models of adolescent risk: implications for prevention and intervention. Dev Psychobiol. 2010 Apr;52(3):213–5. doi: 10.1002/dev.20435.
    1. Queen AH, Barlow DH, Ehrenreich-May J. The trajectories of adolescent anxiety and depressive symptoms over the course of a transdiagnostic treatment. J Anxiety Disord. 2014 Aug;28(6):511–21. doi: 10.1016/j.janxdis.2014.05.007.
    1. Girio-Herrera E, Ehrenreich-May J. Using flexible clinical processes in the unified protocol for the treatment of emotional disorders in adolescence. Psychotherapy (Chic) 2014 Mar;51(1):117–22. doi: 10.1037/a0032517.
    1. Sandín B, Chorot P, Valiente RM, Chorpita BF. Development of a 30-item version of the Revised Child Anxiety and Depression Scale. Rev Psicopatol Psicol Clin. 2010;15(3):165–178. doi: 10.5944/rppc.vol.15.num.3.2010.4095.
    1. Piqueras JA, Martín-Vivar M, Sandin B, San Luis C, Pineda D. The Revised Child Anxiety and Depression Scale: a systematic review and reliability generalization meta-analysis. J Affect Disord. 2017 Aug 15;218:153–169. doi: 10.1016/j.jad.2017.04.022.
    1. Chorot P, Valiente RM, Magaz AM, Santed MA, Sandin B. Perceived parental child rearing and attachment as predictors of anxiety and depressive disorder symptoms in children: the mediational role of attachment. Psychiatry Res. 2017 Jul;253:287–295. doi: 10.1016/j.psychres.2017.04.015.
    1. Sandín B, Chorot P, Valiente RM. TCC de los trastornos de ansiedad: Innovaciones en niños y adolescentes. Madrid: Klinik; 2016.
    1. Chorot P, Magaz A, Valiente RM. Estilos de crianza y vulnerabilidad psicopatológica [Parenting styles and vulnerability to psycholopathology]. Symposium Nacional de Psicología Clínica y de la Salud en Niños y Adolescentes; 2013; Elche (Spain).
    1. Weisz JR, Chorpita BF, Frye A, Ng MY, Lau N, Bearman SK, et al. Youth top problems: Using idiographic, consumer-guided assessment to identify treatment needs and to track change during psychotherapy. J Consult Clin Psychol. 2011 Jun;79(3):369–80. doi: 10.1037/a0023307.
    1. Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581–6.
    1. García P, Goodman R, Mazaria J, Torres A, Rodríguez-Sacristán J, Hervás A. El Cuestionario de Capacidades y Dificultades. Rev Psiquiatr Infanto-Juv. 2000;1:12–17.
    1. Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337–45. doi: 10.1097/00004583-200111000-00015.
    1. Gómez-Beneyto M, Nolasco A, Moncho J, Pereyra-Zamora P, Tamayo-Fonseca N, Munarriz M, Salazar J, Tabarés-Seisdedos R, Girón M. Psychometric behaviour of the strengths and difficulties questionnaire (SDQ) in the Spanish national health survey 2006. BMC Psychiatry. 2013 Mar 22;13:95. doi: 10.1186/1471-244X-13-95.
    1. García-Escalera J, Sandín B, Chorot P, Valiente RM. Escala de Interferencia de la Depresión y Ansiedad para Niños (EIDAN) Madrid, Spain: Universidad Nacional de Educación a Distancia [Unpublished Questionnaire]; 2016.
    1. Sandín B. Escalas PANAS de afecto positivo y negativo para niños y adolescentes (PANASN) Rev Psicopatol Psicol Clin. 2003;8(2):173–182.
    1. Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063–70.
    1. Tortella-Feliu M, Balle M, Sesé A. Relationships between negative affectivity, emotion regulation, anxiety, and depressive symptoms in adolescents as examined through structural equation modeling. J Anxiety Disord. 2010 Oct;24(7):686–93. doi: 10.1016/j.janxdis.2010.04.012.
    1. Silverman WK, Fleisig W, Rabian B, Peterson RA. Childhood Anxiety Sensitivity Index. J Clin Child Adolesc Psychol. 1991;20(2):162–168.
    1. Sandín B. Ansiedad, miedos y fobias en niños y adolescentes. Madrid: Dykinson; 1997.
    1. Sandín B, Chorot P, Santed M, Valiente RM. Análisis factorial confirmatorio del Indice de Sensibilidad a la Ansiedad para Niños. Psicothema. 2002;14(2):333–339.
    1. Kennedy SM, Ehrenreich-May J. Assessment of emotional avoidance in adolescents: psychometric properties of a new multidimensional measure. J Psychopathol Behav Assess. 2016 Nov 7;39(2):279–290. doi: 10.1007/s10862-016-9581-7.
    1. García-Escalera J, Chorot P, Valiente RM, Sandín B, Tonarely N, Ehrenreich-May J. Spanish version of the Emotional Avoidance Strategy Inventory for Adolescents (EASI) Madrid, Spain: Universidad Nacional de Educación a Distancia [Unpublished questionnaire]; 2016.
    1. Sandín B, Chorot P, Valiente RM. Escala de Satisfacción con la Vida para Niños y Adolescentes (SWLS-C) Madrid, Spain: Universidad Nacional de Educación a Distancia [Unpublished questionnaire]; 2015.
    1. Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71–5. doi: 10.1207/s15327752jpa4901_13.
    1. KIDSCREEN Group . The KIDSCREEN Questionnaires: Quality of Life Questionnaires for Children and Adolescents. Lengerich: Pabst Science Publishers; 2006.
    1. Erhart M, Ottova V, Gaspar T, Jericek H, Schnohr C, Alikasifoglu M, et al. Measuring mental health and well-being of school-children in 15 European countries using the KIDSCREEN-10 Index. Int J Public Health. 2009;54(2):160–6. doi: 10.1007/s00038-009-5407-7.
    1. Rosenberg M. Society and the Adolescent Self-Image. Princeton: Princeton University Press; 1965.
    1. Sandín B, Valiente RM, Chorot P. Instrumentos para la evaluación del estrés psicosocial. In: Sandín B, editor. El Estrés psicosocial: Conceptos y consecuencias clínicas. Madrid: Klinik; 2008. pp. 267–346.
    1. Molina J, Chorot P, Valiente RM, Sandín B. Miedo a la evaluación negativa, autoestima y presión psicológica: Efectos sobre el rendimiento deportivo en adolescentes. Cuad Psicol Deporte. 2014;14(3):57–66.
    1. Moral JC, Sánchez-Sosa JC, Villarreal ME. Desarrollo de una escala multidimensional breve de ajuste escolar. REMA. 2010;15(1):1–11.
    1. Sánchez-Sosa JC, Villarreal-González ME, Ávila Guerrero Me, Jiménez Av, Musitu G. Contextos de socialización y consumo de drogas ilegales en adolescentes escolarizados. Psychosocial Intervention. 2014 Apr;23(1):69–78. doi: 10.5093/in2014a7.
    1. Martín MB, Pros RC, Busquets CG, Muntada MC. La indisciplina social e instruccional en adolescentes y universitarios: la influencia del género. Rev Electron Investig Psicoeduc Psigopedag. 2012;10(27):693–712.
    1. Gotzens Busquets C, Cladellas Pros R, Clariana Muntada M, Badia Martín M. Indisciplina instruccional y convencional: su predicción en el rendimiento académico. Rev Colomb Psicol. 2015 Oct 07;24(2):317–330. doi: 10.15446/rcp.v24n2.44148.
    1. American Psychiatric Association Online Assessment Measures. 2013. [2016-09-02]. The Personality Inventory for DSM-5-Brief Form (PID-5-BF) Child Age 11 to 17 .
    1. Sandín B, Valiente RM, Chorot P, García-Escalera J. Spanish Version of the Personality Inventory for DSM-5 Brief Form (PID-5-BF) Child Age 11-17. Madrid, Spain: Universidad Nacional de Educación a Distancia [Unpublished questionnaire]; 2014.
    1. Rapee RM, Wignall A, Sheffield J, Kowalenko N, Davis A, McLoone J, Spence SH. Adolescents' reactions to universal and indicated prevention programs for depression: perceived stigma and consumer satisfaction. Prev Sci. 2006 Jun;7(2):167–77. doi: 10.1007/s11121-006-0035-4.
    1. Johnson C, Burke C, Brinkman S, Wade T. Effectiveness of a school-based mindfulness program for transdiagnostic prevention in young adolescents. Behav Res Ther. 2016 Jun;81:1–11. doi: 10.1016/j.brat.2016.03.002.
    1. Gao F, Earnest A, Matchar DB, Campbell MJ, Machin D. Sample size calculations for the design of cluster randomized trials: a summary of methodology. Contemp Clin Trials. 2015 May;42:41–50. doi: 10.1016/j.cct.2015.02.011.
    1. Faul F, Erdfelder E, Lang A, Buchner AG. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175–91.
    1. Calear AL, Christensen H. Systematic review of school-based prevention and early intervention programs for depression. J Adolesc. 2010 Jun;33(3):429–38. doi: 10.1016/j.adolescence.2009.07.004.
    1. Corrieri S, Heider D, Conrad I, Blume A, König HH, Riedel-Heller SG. School-based prevention programs for depression and anxiety in adolescence: a systematic review. Health Promot Int. 2014 Sep;29(3):427–41. doi: 10.1093/heapro/dat001.
    1. Sánchez-Hernández Ó, Méndez FX, Garber J. Prevención de la depresión en niños y adolescentes: revisión y reflexión. Rev Psicopatol Psicol Clin. 2014;19(1):63–76.
    1. Gallegos J, Linan-Thompson S, Stark K, Ruvalcaba N. Preventing childhood anxiety and depression: testing the effectiveness of a schoolbased program in Mexico. Psicología Educativa. 2013 Jun;19(1):37–44. doi: 10.5093/ed2013a6.
    1. Fiero MH, Huang S, Oren E, Bell ML. Statistical analysis and handling of missing data in cluster randomized trials: a systematic review. Trials. 2016 Feb 09;17:72. doi: 10.1186/s13063-016-1201-z.
    1. Díaz-Ordaz K, Kenward MG, Cohen A, Coleman CL, Eldridge S. Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clin Trials. 2014 Oct;11(5):590–600. doi: 10.1177/1740774514537136.
    1. Nehmy TJ, Wade TD. Reduction in the prospective incidence of adolescent psychopathology: a review of school-based prevention approaches. Mental Health & Prevention. 2014 Dec;2(3-4):66–79. doi: 10.1016/j.mhp.2014.11.002.
    1. Werner-Seidler A, Perry Y, Calear AL, Newby JM, Christensen H. School-based depression and anxiety prevention programs for young people: a systematic review and meta-analysis. Clin Psychol Rev. 2017 Feb;51:30–47. doi: 10.1016/j.cpr.2016.10.005.
    1. Cano-Vindel A, Muñoz-Navarro R, Wood CM, Limonero JT, Medrano LA, Ruiz-Rodríguez P, Gracia-Gracia I, Dongil-Collado E, Iruarrizaga I, Chacón F, Santolaya F. Transdiagnostic cognitive behavioral therapy versus treatment as usual in adult patients with emotional disorders in the primary care setting (PsicAP Study): protocol for a randomized controlled trial. JMIR Res Protoc. 2016 Dec 23;5(4):e246. doi: 10.2196/resprot.6351.
    1. Montero-Marín J, Araya R, Pérez-Yus MC, Mayoral F, Gili M, Botella C, Baños R, Castro A, Romero-Sanchiz P, López-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, García-Campayo J. An internet-based intervention for depression in primary care in Spain: a randomized controlled trial. J Med Internet Res. 2016 Aug 26;18(8):e231. doi: 10.2196/jmir.5695.
    1. Klein DN, Kotov R, Bufferd SJ. Personality and depression: explanatory models and review of the evidence. Annu Rev Clin Psychol. 2011;7:269–95. doi: 10.1146/annurev-clinpsy-032210-104540.

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