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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 主要终点
- Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No other exclusion criteria because of being an universal prevention study
研究组 & 干预措施
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).
干预措施: UP-A adapted as a preventive intervention (Behavioral)
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.
干预措施: Same than experimental group (EG), after EG finishes (Behavioral)
结局指标
主要结局
Change in Revised Child Anxiety and Depression Scale-30 (RCADS-30) at pre, post intervention and at 3 months follow-up.
时间窗: 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.
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.
时间窗: 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.
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.
时间窗: 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.
次要结局
- 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)
- 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)
- Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965)(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)
- 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)(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)
- 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)
- Satisfacion With Life Scale for Children (SWLS-C) (Sandín, Chorot, & Valiente, 2015).(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)(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)