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临床试验/NCT04104841
NCT04104841已完成不适用

School-Based Depression Prevention for Adolescents With ADHD

University of Maryland, College Park2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Children's Depression Inventory, 2nd Edition (CDI-2)

研究概览

简要总结

The purpose of this study is to develop a modified behavioral activation program in adolescents with ADHD to be implemented by school mental health providers in an urban, low-income school district. Subsequently the investigators will examine its effectiveness in reducing depressive symptoms and improving emotion regulation and reward responsivity, compared to usual care.

详细描述

Children with ADHD are at elevated risk for depression in adolescence and young adulthood, and this comorbidity is associated with far greater impairment than either disorder alone, including higher rates of inpatient hospitalization and increased risk for suicidal ideation and behavior. Despite these adverse outcomes, existing evidence-based interventions for ADHD have not demonstrated effects in reducing depressive symptoms nor do established depression prevention programs work as well for adolescents with ADHD. Reward responsivity (RR) and emotion regulation (ER) are two key factors demonstrated to mediate the association between ADHD and depression and are thus key targets for prevention. In an effort to address the gap between access and utilization of mental health care, which is especially stark among adolescents with ADHD, the investigators aim to develop and test a modified behavioral activation prevention program [Behaviorally Enhancing Adolescents' Mood in Schools (BEAM-S)] that incorporates modules to directly target these purported mechanisms. In line with the Deployment-Focused Model of Intervention Development and Testing, the investigators will develop a program that can be easily implemented and sustainable in the high school setting as delivered by school mental health staff that reduces depression and improves overall functioning in adolescents with ADHD, by way of improving RR and ER. As a first step, the investigators will conduct focus groups with community stakeholders (e.g., school mental health providers, school administration, adolescents, parents, teachers) to develop an acceptable and sustainable selected and indicated prevention program for school staff to utilize. The investigators will then initially train school staff to deliver this prevention program via to pilot the intervention for implementation of the prevention program in a case series to evaluate preliminary feasibility. The investigators will then conduct a stage 1 RCT with a hybrid-type 1 implementation effectiveness design in three high schools where adolescents will be randomized to either the BEAM-S condition (n= 54) or treatment as usual (n = 54). Finally, qualitative and quantitative data from aims 1-3 will be used to prepare final procedures for a future large-scale effectiveness trial R01 (aim 4).

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
None

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in a participating Baltimore City Public High School
  • DSM-5 Diagnosis of attention-deficit/hyperactivity disorder (ADHD)
  • Depressive symptoms above T=65 on the Children's Depression Inventory (CDI)

排除标准

  • History of seizures or neurological problems
  • DSM-diagnosis of Pervasive Developmental Disorder
  • Full scale IQ below 70
  • Current depressive symptoms or active suicidality at severe levels where more intensive services would be warranted

结局指标

主要结局

Children's Depression Inventory, 2nd Edition (CDI-2)

时间窗: 12-week follow-up

Adolescent and parent reported depressive symptoms

次要结局

  • Suicide Behavior Questionnaire(12-week follow-up)
  • Affective Reactivity Index(12-week follow-up)
  • Mirror Tracing Persistence Task(12-week follow-up)
  • Tripartite Pleasure Inventory(12-week follow-up)
  • Behavioral Activation for Depression Scale(12-week follow-up)
  • Emotion Regulation Checklist(12-week follow-up)
  • Difficulties in Emotion Regulation(12-week follow-up)
  • Impairment Rating Scale(12-week follow-up)
  • Reward Probability Index(12-week follow-up)
  • Balloon Analog Risk Task(12-week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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