Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from Baseline Emotional Go/No-Go Task at End of Treatment
研究概览
简要总结
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
详细描述
This project will implement and evaluate the Child STEPs treatment approach as compared to "treatment as usual" (known as Usual Care or UC) through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the STEPs modules. The project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •enrolled in grades 3-7
- •have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
- •clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress Disorder Reaction Index.
排除标准
- •Mental retardation
- •Pervasive developmental disorder
- •Eating disorder
- •children for whom attention problems or hyperactivity are the primary referral concern
- •active psychosis and/or a suicide attempt in the previous year
- •To participate in the two neuroimaging tasks (Emotion Regulation Task; Emotional Go/No Go Task), participants must be healthy (no major medical illness), right-handed, fluent in English, have no history of neurological impairment (including but not limited to history of loss of consciousness for great than 20 minutes, seizures, stroke, etc.), have normal or corrected to normal vision, and have no contra-indications or risk factors for MRI research (such as braces or metal implants).
结局指标
主要结局
Change from Baseline Emotional Go/No-Go Task at End of Treatment
时间窗: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Emotion Regulation Task at End of Treatment
时间窗: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
次要结局
- Change from Baseline Attentional Bias Task at End of Treatment(Change over time from Day 1 to end of treatment, assessed up to 40 weeks)
- Change from Baseline Granularity Task at End of Treatment(Change over time from Day 1 to end of treatment, assessed up to 40 weeks)
- Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment(Change over time from Day 1 to end of treatment, assessed up to 40 weeks)
- Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment(Change over time from Day 1 to end of treatment, assessed up to 40 weeks)
研究者
John Weisz
Professor and Primary Investigator
Harvard University